Topamax

(topiramate)

ApprovedSmall molecule

Topiramate is used to treat epilepsy (seizures) and to prevent migraines. It can also help with weight loss and is sometimes used to treat bipolar disorder.[2] Topamax is currently approved and in use across 42 indications[4].[1]

Topamax is one of 666 small molecule programs targeting Headache. It is currently in Approved.

Indications

198

Total Trials

Active Trials

665

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

MigraineCompleted

HypertriglyceridemiaApproved

DeafnessApproved

HypertensionApproved

Binge EatingApproved

Multiple SclerosisApproved

Nicotine DependenceApproved

HyperlipidemiaApproved

Epilepsy With Generalized Tonic-Clonic SeizuresApproved

Cognitive ImpairmentApproved

MigraineApproved

Completed

HypertriglyceridemiaApproved

Approved

DeafnessApproved

Approved

HypertensionApproved

Approved

Binge EatingApproved

Approved

Multiple SclerosisApproved

Approved

Nicotine DependenceApproved

Approved

HyperlipidemiaApproved

Approved

Epilepsy With Generalized Tonic-Clonic SeizuresApproved

Approved

Cognitive ImpairmentApproved

Approved

Showing 10 of 39 indications

Competition

Competitive Landscape

174 competitors in Schizophrenia

#DrugCompanyPhaseTrials

Topamax

WWim Janssens

Approved

2 2

Inapsine

Jazz Pharmaceuticals

Preclinical

1 3

Ozempic

Novo Nordisk

Preclinical

1 4

Resotran

Takeda

Preclinical

1 5

Depakote

Ibrance

Lunesta

3 8

Persantine

Boehringer Ingelheim

Preclinical

1 9

Luvox

SSolvay Pharmaceuticals

Preclinical

1 10

Catapres

Boehringer Ingelheim

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalActive, not recruiting

Migraine

NCT06799169

Post-ApprovalNot yet recruiting

Migraine

NCT06499116

Q3 2027

Post-ApprovalRecruiting

Bariatric Surgery

NCT05975580

Q3 2028

Phase 1/2Not yet recruiting

HIV

NCT07384624

Recruiting

Lactating Women on Select DOI

NCT03511118

Q4 2029

ApprovedRecruiting

Migraine

NCT06972056

Clinical

Trials by Indication[1]

Migraine34 trials

An Observational Study Evaluating the Safety of Topiramate for the Prevention of Migraine

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT00297336·80 enrolled

The Childhood and Adolescent Migraine Prevention Study

Terminated·—·Phase 3·NCT01581281·488 enrolled

Cognitive Side Effects of Commonly Prescribed Medications in Pediatric Migraine

Withdrawn·UUniversity of South Alabama·N/A·NCT00777218

Show 31 more trials

Mechanism-based Choice of Therapy for Pain: Can Successful Prevention of Migraine be Coupled to a Psychophysical Pain Modulation Profile?

Completed·RRambam Health Care Campus·N/A·NCT01161017·67 enrolled

Trial of Nortriptyline and Topiramate in the Initial Treatment of Vestibular Migraine

Terminated·SSt. Louis University·N/A·NCT02169830·35 enrolled

Comparison of Therapeutic Effects of Greater Occipital Nerve Block, Topiramate, and Flunarizine on Episodic Migraine

Completed·—·N/A·NCT03712917·120 enrolled

Management of Acute Tinnitus With Migraine Medications

Active, not recruiting·UUniversity of California, Irvine·Phase 4·NCT06799169·100 enrolled

A Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine

Completed·MMonarch Medical Research·Phase 2·NCT00158002·40 enrolled

Is Topiramate Effective in Treating Dizziness in Patient's With Migraine-Associated Dizziness

Withdrawn·UUniversity of California, San Francisco·N/A·NCT00732108

A Study of the Efficacy and Safety of Topiramate in the Prevention of Migraine

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00231595·768 enrolled

Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine

Completed· Novartis logo

Novartis·Phase 4·NCT03828539·777 enrolled

Migraine Treatment in ED

Withdrawn·NNYU Langone Health·N/A·NCT02643719

Zolmitriptane as Prophylaxis for Chilhood Migraine

Unknown status·TTanta University·Phase 4·NCT06089356·90 enrolled

An Open Label Extension of a Study of Topiramate in Chronic Migraine.

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00210873·200 enrolled

Pilot Study to Compare Frovatriptan vs. Topiramate for Prevention of Migraine

Completed·CClinvest·Phase 4·NCT00846495·55 enrolled

A Study of the Efficacy and Safety of Topiramate in the Prevention of Migraine

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00236509·763 enrolled

Dose Comparison Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine

Completed·MMonarch Medical Research·Phase 2/3·NCT00131443·40 enrolled

A Dose-Finding Study of Topiramate (JNS019) in Participants With Migraine

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT01081795·387 enrolled

A Study of the Effectiveness and Safety of Topiramate for the Prevention of Migraine

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00253175·211 enrolled

Comparison of the Effectiveness of First-line Preventive Treatment of Migraine in Primary Care

Not yet recruiting·FFundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina·Phase 4·NCT06499116·460 enrolled

Does Topiramate Adjust the Excitability of the Brain in Migraine Sufferers?

Unknown status·EEmerald City Headache Organization··NCT00286923·10 enrolled

NINDS CRC Chronic Migraine Treatment Trial

Completed·AAnne Lindblad·Phase 3·NCT00772031·191 enrolled

An Open Label Extension of a Study Comparing Topiramate and Amitriptyline in Migraine Prevention.

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00210860·142 enrolled

Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults

Completed· AbbVie logo

AbbVie·Phase 4·NCT02191579·282 enrolled

Flunarizine Versus Topiramate for Chronic Migraine Prophylaxis

Completed·TTaipei Veterans General Hospital, Taiwan·Phase 4·NCT02639598·62 enrolled

The Effectiveness and Safety of Topiramate on Prevention of Chronic Migraine

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00216606·59 enrolled

Zonisamide Versus Topiramate in Migraine

Recruiting·KKafrelsheikh University·Phase 3·NCT06347497·600 enrolled

Valproate Versus Topiramate in Migraine

Completed·KKafrelsheikh University·Phase 3·NCT06248931·600 enrolled

Topiramate and Cerebrovascular Response in Migraineurs

Completed·SSMG-SNU Boramae Medical Center·Phase 4·NCT02424318·19 enrolled

Continuous Treatment Study of Topiramate in Migraine Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT01799590·296 enrolled

An Open-label Study to Evaluate Topiramate Therapy in Migraine Patients, and Its Effects on Subject Responsiveness to Migraine Treatment With Triptans

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT00261469·38 enrolled

Acupuncture in Chronic Migraine: A Randomized Controlled Trial

Completed·—·N/A·NCT01096420·68 enrolled

A Comparative Effectiveness Study of Oral Medications Used for Migraine Prevention: The APT Comparison Study

Recruiting·MMayo Clinic·Approved·NCT06972056·1,335 enrolled

A Randomized, Double-Blind, Parallel-Group, Active Controlled Trial With Open-Label Safety Extension to Evaluate the Tolerability, Safety, and Efficacy of Atogepant Versus Topiramate in Subjects Requiring Preventive Treatment of Migraine (TEMPLE)

Completed· AbbVie logo

AbbVie·Phase 3·NCT05748483·545 enrolled

Epilepsy20 trials

A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures.

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00236873·47 enrolled

A Cross-sectional Study to Investigate the Effect of Topiramate on Bone and Mineral Metabolism in Female Participants With Epilepsy

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT01030094·140 enrolled

A Study of the Efficacy and Safety of Topiramate as "Add on" Treatment in Epilepsy Patients With Primary Generalized Tonic-clonic Seizures

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00236704·80 enrolled

Show 17 more trials

A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02201251·63 enrolled

Prospective Pilot Study on Metabolism and Weight Changes in Topiramate-Treated Epilepsy Patients

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00236886·49 enrolled

A Study on Safety and Efficacy of Two Doses of Topiramate as Monotherapy in the Treatment of Newly Diagnosed or Recurrent Epilepsy

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00231556·750 enrolled

A Study of the Efficacy and Safety of Topiramate in the Treatment of Patients With Difficult to Control Epilepsy

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00236730·178 enrolled

A Study to Assess Tolerability and Efficacy of Topiramate Monotherapy in Recently Diagnosed Patients With Epilepsy

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT01689649·139 enrolled

An Observational Study to Evaluate Long-term Retention Rate of Topiramate in Participants With Epilepsy

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT01682681·1,234 enrolled

An Observational Study of the Safety of Topiramate in Adults and Children With Epilepsy

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT00297323·80 enrolled

A Study to Evaluate the Dosing, Effectiveness and Safety of Topiramate for the Treatment of Epilepsy

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 4·NCT00266604·409 enrolled

A Study of the Effectiveness and Safety of Topiramate in the Treatment of Children With Epilepsy

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00236743·90 enrolled

A Study of the Efficacy and Safety of Topiramate in Epilepsy Patients With Primary Generalized Tonic-clonic Seizures

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00236418·80 enrolled

A Study of the Efficacy and Safety of Topiramate in the Treatment of Patients With Epilepsy.

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00236847·60 enrolled

Carisbamate Retention Study (CaReS): Comparative Study on the Long Term Effectiveness, Safety and Tolerability of Carisbamate Compared to Two Other Frequently Prescribed Anti-epileptic Drugs (AEDs) in Patients With Epilepsy.

Terminated·SSK Life Science, Inc.·Phase 3·NCT00563459·89 enrolled

Effect of Anti-epileptic Drugs on Etonogestrel-releasing Implant Pharmacokinetics in Women With Epilepsy

Suspended·UUniversity of Sao Paulo·Phase 4·NCT03307863·69 enrolled

Characterization of Epilepsy Patients BEEP 2b

Completed·FFood and Drug Administration (FDA)·Phase 1·NCT02707965·21 enrolled

A Study of the Efficacy and Safety of Topiramate Treatment in Patients With Epilepsy

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00266591·51 enrolled

A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00236860·56 enrolled

A Study of the Efficacy and Safety of Topiramate as add-on Therapy in the Treatment of Epilepsy Patients With Difficult to Treat, Partial-onset Seizures.

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00236691·188 enrolled

Obesity7 trials

Topiramate in Adolescents With Severe Obesity

Completed·UUniversity of Minnesota·Phase 2·NCT01859013·34 enrolled

Anti-obesity Pharmacotherapy and Inflammation

Active, not recruiting·LLouisiana State University Health Sciences Center in New Orleans··NCT05756764·30 enrolled

A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults

Completed·VVIVUS LLC·Phase 3·NCT00563368·756 enrolled

Show 4 more trials

A Study on Efficacy and Safety of Topiramate in the Treatment of Patients With Obesity

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00236639·1,293 enrolled

A Study of Safety and Efficacy of Topiramate in Male Patients With Abdominal Obesity

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00231608·68 enrolled

A Study on Efficacy and Safety of Topiramate in the Treatment of Patients With Obesity

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00236613·385 enrolled

Topiramate and Severe Obesity

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT02273804·18 enrolled

Headache7 trials

The Prolonged Use of Topiramate for Preventing Migraine Headaches

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00216619·834 enrolled

Detoxification and Treatment of Subjects With Medication Overuse Headache

Unknown status·TThe New England Center for Headache, P.C.·Phase 4·NCT00432549·60 enrolled

A Study of the Effectiveness and Safety of Topiramate Versus Placebo for Preventing Chronic Migraine Headaches

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00210912·328 enrolled

Show 4 more trials

Evaluation of the Effectiveness of Topiramate in Preventing the Transformation From Episodic Migraine to Chronic Daily Headache.

Completed·OOrtho-McNeil Neurologics, Inc.·Phase 4·NCT00212810·385 enrolled

A Comparison of the Efficacy and Safety of Topiramate Versus Placebo in Preventing Migraine Headaches in Children

Completed·OOrtho-McNeil Neurologics, Inc.·Phase 3·NCT00237302·162 enrolled

Comparing the Safety and Effectiveness of Topiramate With the Safety and Effectiveness of Amitriptyline in Preventing Migraine Headaches

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00210821·347 enrolled

Medical Therapies for Chronic Post-Traumatic Headaches

Terminated·MMadigan Army Medical Center·Phase 4·NCT00862095·64 enrolled

Alcohol Dependence6 trials

The Use of Anticonvulsants for Treatment of Patients With Alcohol Dependence and Post Traumatic Stress Disorder

Withdrawn·YYale University·Phase 3·NCT00571246

New Medications to Treat Alcohol Dependence

Completed·BBankole Johnson·Phase 2·NCT00223639·29 enrolled

Defining the Clinical Role of Topiramate in the Treatment of Alcohol Dependence in Australia

Unknown status·SSouth West Sydney Local Health District·Phase 3·NCT03479086·180 enrolled

Show 3 more trials

A Controlled Trial of Topiramate Treatment for Alcohol Dependence in Veterans With PTSD

Completed·UUniversity of California, San Francisco·Phase 4·NCT01749215·151 enrolled

An Efficacy and Safety Study of Topiramate in the Treatment of Alcohol Dependence

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00210925·371 enrolled

Adjunctive Topiramate for Treatment of Alcohol Dependence in Patients With Bipolar Disorder

Completed·SStanford University·Phase 4·NCT00572117·12 enrolled

76 more indications

Seizure5 trials

Topiramate as Adjunctive Therapy in Infants 1-24 Months for the Control of Partial Onset Seizures

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00113815·118 enrolled

A Study of the Safety of Topiramate Given in Combination With Other Medications in Adults and Children With Seizures

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT00297349·153 enrolled

A Study of the Pharmacokinetics, Safety and Tolerability of Topiramate in Infants (Age 1-24 Months) With Refractory Partial-onset Seizures

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT00233012·16 enrolled

Show 2 more trials

A Study of the Effectiveness and Safety of Topiramate Monotherapy in Patients With Recently Diagnosed Partial-Onset Seizure

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00230698·451 enrolled

Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures

Completed· UCB logo

UCB·Phase 4·NCT01229735·343 enrolled

Bipolar Disorder4 trials

A Study of the Effectiveness and Safety of Topiramate in the Treatment of Patients With Bipolar Disorder

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00240721·363 enrolled

A Pharmacokinetic Study of Lithium Before and During Topiramate Dosing in Bipolar Disorder Patients

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT00986128·32 enrolled

Topiramate vs. Placebo in Preventing Weight Gain in Bipolar Disorder Treated With Olanzapine

Completed·UUniversity of Cincinnati·Phase 4·NCT00394095·31 enrolled

Show 1 more trial

Topiramate Versus Placebo as add-on Treatment in Patients With Bipolar Disorder in the Outpatient Setting

Completed·OOrtho-McNeil Neurologics, Inc.·Phase 3·NCT00237289·287 enrolled

Cocaine Dependence4 trials

Topiramate-Phentermine Combinations for Cocaine Dependence

Completed·UUniversity of Kentucky·Phase 1·NCT02239913·38 enrolled

Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence

Completed·NNew York State Psychiatric Institute·Phase 2/3·NCT01811940·169 enrolled

Topiramate for Alcohol and Cocaine Dependence

Completed·KKyle Kampman·Phase 2·NCT00167245·170 enrolled

Show 1 more trial

Topiramate to Reduce Cocaine Dependence

Completed·BBankole Johnson·Phase 2·NCT00223626·25 enrolled

Eating Disorder4 trials

A Study of the Effectiveness and Safety of Topiramate in the Treatment of Moderate to Severe Binge-eating Disorder Associated With Obesity

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2/3·NCT00210808·407 enrolled

An Efficacy and Tolerability Study for Topiramate in Obese Patients With Binge Eating Disorder.

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00307619·73 enrolled

Topiramate for Binge Eating Disorder Among Adolescents

Completed·—·N/A·NCT00768677

Show 1 more trial

Topiramate for the Treatment of Alcohol Dependent Binge-Eating Disordered Individuals

Completed·UUniversity of Virginia·Phase 2·NCT00300742·5 enrolled

Fasting Conditions4 trials

Topiramate 25 mg Tablets Under Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00905606·30 enrolled

Topiramate 25 mg Capsules Under Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00905164·24 enrolled

Topiramate 25 mg Capsule Mixed With Applesauce Under Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00905346·24 enrolled

Show 1 more trial

Bioequivalence Study of Topiramate Tablets 25mg Under Fasting Conditions

Completed·RRanbaxy Laboratories Limited·N/A·NCT00901784·28 enrolled

Bipolar I Disorder3 trials

A Study to Evaluate the Safety and Effectiveness of Topiramate Compared to Placebo in the Treatment of Patients With Bipolar I Disorder

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00035802·13 enrolled

A Study on the Safety and Efficacy of Topiramate in the Treatment of Patients With Bipolar I Disorder

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00035230·338 enrolled

A Study on the Safety and Efficacy of Topiramate in the Treatment of Patients With Bipolar I Disorder

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00037674·434 enrolled

Post-Traumatic Stress Disorder3 trials

Topiramate in the Treatment of Posttraumatic Stress Disorder in Civilians

Completed·—·Phase 4·NCT00208130·60 enrolled

Safety & Efficacy Study Using Topiramate in Posttraumatic Stress Disorder

Completed·UUniversity of Oklahoma·Phase 2/3·NCT00204386·50 enrolled

Topiramate for Alcohol Use in Posttraumatic Stress Disorder

Terminated·UUniversity of Maryland, Baltimore·N/A·NCT01408641·4 enrolled

Efficacy and Safety3 trials

A Study on Efficacy and Safety of Topiramate OROS Controlled-Release in Obese, Type 2 Diabetic Subjects Managed With Diet or Metformin

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00231647·113 enrolled

A Study on Efficacy and Safety of Topiramate in Treatment of Obese Subjects With Dyslipidemia

Terminated· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00231621·179 enrolled

Efficacy and Safety of Danzhen

Unknown status·XXijing Hospital·Phase 1·NCT02645370·3,300 enrolled

Post-Traumatic Stress Disorder, PTSD3 trials

Topiramate in the Treatment of Post Traumatic Stress Disorder (PTSD)

Completed·TTuscaloosa Research & Education Advancement Corporation·Phase 4·NCT00203463·40 enrolled

Topiramate Treatment of Alcohol Use Disorders in Veterans With Post Traumatic Stress Disorder (PTSD): A Pilot Controlled Trial of Augmentation Therapy

Completed·UUniversity of California, San Francisco·Phase 4·NCT01087736·30 enrolled

Placebo Controled Clinical Trial Using Topiramate To Treat Posttraumatic Stress Disorder (PTSD) Patients.

Completed·FFederal University of São Paulo·Phase 4·NCT00725920·35 enrolled

Parkinson's Disease3 trials

Quantification of the Antidyskinetic Effect of Amantadine and Topiramate in Parkinson's Disease

Terminated·OOregon Health and Science University·N/A·NCT00794313·3 enrolled

Topiramate as a Treatment for Levodopa-Induced Dyskinesia in Parkinson's Disease

Terminated·UUniversity Health Network, Toronto·Phase 2·NCT00296959·20 enrolled

Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease

Terminated·RRush University Medical Center·Phase 2·NCT01789047·42 enrolled

Weight loss3 trials

Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With Obesity

Terminated·UUniversity of Iowa·Phase 2·NCT01351753·128 enrolled

Topiramate: Long-Term Maintenance of Weight Loss Induced by Low-Calorie Diet in Obese Subjects

Terminated·UUniversity of Copenhagen·Phase 4·NCT02040311·701 enrolled

A Study on Efficacy and Safety of Topiramate in Maintaining Weight Loss in Obese Patients Following an Intensive, Non-Pharmacologic Weight Loss Program

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00236600·561 enrolled

Smoking Cessation3 trials

Topiramate to Aid Smoking Cessation in Alcohol Dependent Men

Completed·VVA Office of Research and Development·Phase 2·NCT00802412·132 enrolled

Topiramate Alone and in Combination With the Nicotine Patch for Smoking Cessation: A Pilot Study

Completed·UUConn Health·Phase 3·NCT00755716·57 enrolled

Safety and Efficacy Study of Topiramate to Aid in Smoking Cessation

Completed·LLindner Center of HOPE·Phase 3·NCT00280839·87 enrolled

Bariatric Surgery3 trials

Pharmacotherapy in Conjunction With Lifestyle Counseling for Management of Weight Regain After Bariatric Surgery

Recruiting·UUniversity of California, Irvine·Phase 4·NCT05975580·120 enrolled

Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds

Completed·UUniversity of Colorado, Denver·Phase 2·NCT04095104·13 enrolled

Medications After Adolescent Bariatric Surgery

Withdrawn·JJaney Pratt·Phase 2·NCT04572217

Fed2 trials

Bioequivalence Study of Topiramate Tablets 25mg Under Fed Conditions

Completed·RRanbaxy Laboratories Limited·N/A·NCT00902473·18 enrolled

Topiramate 25 mg Capsules Under Fed Conditions

Completed· Teva logo

Teva·Phase 1·NCT00904943·18 enrolled

Bulimia Nervosa2 trials

Study on the Optimal Strategy of Chinese Patients With Bulimia Nervosa After Fluoxetine Treatment

Unknown status·SShanghai Mental Health Center·N/A·NCT04154813·550 enrolled

Topiramate Augmentation in Bulimia Nervosa Partial Responders

Withdrawn·NNeuropsychiatric Research Institute, Fargo, North Dakota·Phase 4·NCT00988481

Type 2 Diabetic Patients2 trials

A Study of the Efficacy and Safety of Topiramate in the Treatment fo Obese, Type 2 Diabetic Patients Treated With Metformin

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00231660·211 enrolled

A Study of the Efficacy and Safety of Topiramate in Obese, Type 2 Diabetic Patients Inadequately Controlled on Sulfonylurea Therapy

Terminated· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00231634·31 enrolled

Hospitalized Patients2 trials

Topiramate for Hospitalized Patients With Alcoholism: a 12-week Study

Unknown status·—·Phase 4·NCT01135602·150 enrolled

Efficacy of Topiramate for Hospitalized Patients With Alcoholism

Completed·—·Phase 2/3·NCT01145677·90 enrolled

Obsessive-Compulsive Disorder2 trials

Study to Determine the Efficacy and Safety of Adjunctive Topiramate in the Treatment of Obsessive-Compulsive Disorder

Completed·UUniversity of Florida·Phase 3·NCT00187928·96 enrolled

Topiramate Augmentation in the Treatment of Obsessive-Compulsive Disorder

Completed·MMontefiore Medical Center·Phase 4·NCT00211744·24 enrolled

MACE2 trials

Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Topiramate Tablets Under Fed Conditions

Completed·TTorrent Pharmaceuticals Limited·Phase 1·NCT00939705·18 enrolled

Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Topiramate Tablets Under Fasted Conditions

Completed·TTorrent Pharmaceuticals Limited·Phase 1·NCT00939692·26 enrolled

Alcohol Use2 trials

Effects of Topiramate on Adolescent Alcohol Use: Efficacy and Mechanisms

Completed·—·Phase 1/2·NCT01641445·82 enrolled

The Effects of Topiramate on Alcohol Use in Alcohol Dependent Subjects

Completed·—·Phase 4·NCT00329407·10 enrolled

Type 2 Diabetes2 trials

A Study of the Safety and Efficacy of Topiramate in the Treatment of Obese, Type 2 Diabetes Patients on a Controlled Diet

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00231530·541 enrolled

A Study of the Safety and Effectiveness of Topiramate on Insulin Sensitivity in Overweight or Obese Patients With Type 2 Diabetes

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00236626·38 enrolled

Heavy Drinker2 trials

A Randomized, Double-blind Placebo-Controlled Pharmacogenetic Study of Topiramate in European-American Heavy Drinkers

Completed·UUniversity of Pennsylvania·Phase 2·NCT02371889·320 enrolled

Topiramate to Reduce Heavy Drinking in HIV-Positive Heavy Drinkers

Terminated·UUniversity of Pennsylvania·Phase 2·NCT01764685·4 enrolled

Schizophrenia2 trials

Topiramate and Schizophrenia: Effects on Weight and Psychopathology

Unknown status·CCentre for Addiction and Mental Health·N/A·NCT02808533·50 enrolled

Topiramate vs Metformin on Cardio-Metabolic Profile in Schizophrenia on Atypical Antipsychotics

Completed·—·Phase 4·NCT05663749·60 enrolled

Cognition2 trials

Physiologic Effects of Topiramate on Cognition

Completed·UUniversity of Florida·Phase 1·NCT02884050·11 enrolled

Characterizing and Predicting Drug Effects on Cognition

Completed·UUniversity of Minnesota·Phase 4·NCT01889602·60 enrolled

Lennox-Gastaut syndrome2 trials

Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome

Completed·NNational Center for Research Resources (NCRR)·Phase 3·NCT00004776·10 enrolled

A Study of the Efficacy and Safety of Topiramate as an add-on Therapy in the Treatment of Epilepsy Patients With Lennox-Gastaut Syndrome

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00236756·100 enrolled

Treatment2 trials

Topiramate Treatment of Problem Drinkers

Completed·UUConn Health·Phase 4·NCT00626925·200 enrolled

Efficacy of Adding Topiramate to Current Treatment in Treatment-Resistant Generalized Social Phobia (GSP)

Terminated·MMcMaster University·Phase 4·NCT00182455·12 enrolled

Tourette syndrome2 trials

A Randomized, Placebo-controlled, Tourette Syndrome Study.

Completed·—·Phase 3·NCT00206323·29 enrolled

An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome.

Completed·—·Phase 3·NCT00206336·20 enrolled

Pilot Study1 trial

A Pilot Study of the Neural Correlates of Treatment Effect on Nicotine Craving

Completed·EEmory University·Phase 2·NCT00208858

Brain Injury1 trial

Preventing Epilepsy After Traumatic Brain Injury With Topiramate

Terminated·UUniversity of Pennsylvania·Phase 1·NCT00598923·6 enrolled

Cluster headache1 trial

A Double-Blind, Placebo-Controlled Study Examining the Use of Topiramate in the Treatment of Cluster Headache

Terminated·TThomas Jefferson University·Phase 4·NCT00203190·60 enrolled

Alcohol Use Disorder1 trial

Leveraging Biomarkers for Personalized Treatment of Alcohol Use Disorder Comorbid With PTSD

Recruiting·NNYU Langone Health·Phase 2·NCT03667846·150 enrolled

TED1 trial

Topiramate on Gambling-Related Behaviours

Withdrawn·CCentre for Addiction and Mental Health·Phase 2·NCT00370188

Pediatrics1 trial

Population Pharmacokinetics of Antiepileptic in Pediatrics

Completed·AAssistance Publique - Hôpitaux de Paris··NCT03196466·753 enrolled

Prolonged1 trial

Topiramate and Prolonged Exposure

Completed·VVA Office of Research and Development·Phase 2/3·NCT03176953·100 enrolled

Tremor1 trial

A Comparison of the Efficacy and Safety of Topiramate Versus Placebo in Treating Tremor of Unknown Cause.

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00236496·223 enrolled

HIV-11 trial

Studying Topiramate for Re-Activating the HIV-1 Reservoir

Unknown status·EErasmus Medical Center·Phase 1/2·NCT06282783·12 enrolled

Adult1 trial

Pharmacokinetic Comparison of Multiple Formulations of Topiramate and Phentermine in Obese Adults

Completed·VVIVUS LLC·Phase 1·NCT00518466·64 enrolled

Alcoholism1 trial

Interdisciplinary Study of Two Novel Anticonvulsants in Alcoholism

Terminated·—·Phase 2·NCT00862563·85 enrolled

Rett syndrome1 trial

Study of the Pathogenesis of Rett Syndrome

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·N/A·NCT00004807·120 enrolled

Methamphetamine Dependence1 trial

Topiramate for the Treatment of Methamphetamine Dependence - 1

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00345371·140 enrolled

Intravenous1 trial

Pharmacokinetics and Safety of Intravenous Topiramate in Adult Patients

Completed·UUniversity of Minnesota·Phase 1·NCT00753493·20 enrolled

Prader-Willi syndrome1 trial

Study of the Efficacy of Topiramate in Patients With Prader Willi Syndrome Over 8 Weeks

Terminated·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT02810483·69 enrolled

Sudden Sensorineural Hearing Loss1 trial

The Role of Migraine Prophylaxis Agent Topiramate in Treating Patients With Sudden Sensorineural Hearing Loss

Unknown status·—·Phase 2·NCT05403229·140 enrolled

Restless Legs Syndrome1 trial

Efficacy and Safety Study of Topiramate to Treat Restless Legs Syndrome

Completed·NNeurocare·Phase 4·NCT00200941·44 enrolled

Schizoaffective Disorder1 trial

A Pharmacokinetic Study of Risperidone and Topiramate Administered Alone and in Combination in Patients With Bipolar Disorder or Schizoaffective Disorders

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT00986336·56 enrolled

Polycystic Ovary Syndrome1 trial

Treatment of Obesity With Topiramate in Patients With Polycystic Ovary Syndrome

Unknown status·HHospital de Clinicas de Porto Alegre·Phase 4·NCT04453306·80 enrolled

Shivering1 trial

Study of Human Non-Shivering Thermogenesis and Basal Metabolic Rate

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT01950520·47 enrolled

Essential Hypertension1 trial

A Study of Efficacy and Safety of Topiramate in the Treatment of Obese Patients With Mild to Moderate Essential Hypertension

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 3·NCT00236665·531 enrolled

Concentration1 trial

The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users

Completed·UUniversity of Colorado, Denver·Phase 1·NCT03335163·48 enrolled

Pathological Gambling1 trial

Topiramate in the Treatment of Pathological Gambling

Terminated·IIcahn School of Medicine at Mount Sinai·Phase 3·NCT00245583·42 enrolled

Clinical Trial1 trial

Clinical Trial of Topiramate for Cocaine Addiction

Completed·JJohns Hopkins University·Phase 2·NCT00685178·250 enrolled

Borderline personality disorder1 trial

Topiramate for Treatment of Patients With Borderline Personality Disorder and Alcohol Dependence

Withdrawn·EElizabeth Ralevski·Phase 3·NCT00463775

Vomiting1 trial

Topiramate for the Prophylactic Treatment of Cyclic Vomiting Syndrome in Children

Terminated·MMonarch Medical Research·Phase 4·NCT00286988·12 enrolled

ART1 trial

A Study of Lasmiditan in Healthy Participants When Co-administered With Topiramate

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT03308669·30 enrolled

Randomized1 trial

Modified Atkins Diet Versus Topiramate In Children With Epileptic Spasms Refractory To Hormonal Treatment: A Randomized Open-Label Study

Unknown status·LLady Hardinge Medical College·Phase 2/3·NCT05958160·70 enrolled

Self-injurious behavior1 trial

Treatment of Self-Injurious Behavior in Individuals With Prader-Willi Syndrome

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·N/A·NCT00065923·10 enrolled

Adolescent1 trial

Biobehavioral Effects of Topiramate on Cannabis-Related Outcomes in Adolescents

Completed·—·Phase 2·NCT01110434·66 enrolled

Obsessive Compulsive Disorder (OCD)1 trial

Efficacy of Adding Topiramate to Current Treatment in Refractory Obsessive Compulsive Disorder (OCD)

Completed·MMcMaster University·Phase 4·NCT00182520·23 enrolled

Metabolic Syndrome1 trial

Efficacy of Topiramate for Weight Loss in Subjects With Metabolic Syndrome

Suspended·—·Phase 3·NCT00243984·90 enrolled

Trial1 trial

Topiramate Trial for Compulsive Buying

Completed·UUniversity of Sao Paulo·Phase 2·NCT02138058·42 enrolled

Childhood Absence Epilepsy1 trial

A Pilot Study of Topiramate in Childhood Absence Epilepsy

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00210574·12 enrolled

Congenital Heart Disease1 trial

Preventing Brain Injury in Infants With Congenital Heart Disease

Completed·UUniversity of California, Davis·Phase 1·NCT01426542·24 enrolled

Alcohol Use Disorders1 trial

Topiramate Treatment of Alcohol Use Disorders in African Americans

Terminated·VVA Office of Research and Development·Phase 4·NCT03018704·79 enrolled

Monotherapy1 trial

A Multicenter Comparative Trial of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies

Completed· Eisai logo

Eisai·Phase 4·NCT00154076·140 enrolled

Botox1 trial

A Study to Evaluate the Tolerability of Botox and Topiramate or Botox and Placebo and Effect on Cognitive Efficiency

Completed·—·Phase 4·NCT01700387·20 enrolled

Learning Disability1 trial

Topiramate Treatment for Patients With Epilepsy and Learning Disability : A Prospective Observational Study

Unknown status·—··NCT00956696·50 enrolled

HIV1 trial

Combining Latency Reversing Agents to Address the HIV Reservoir

Not yet recruiting·EErasmus Medical Center·Phase 1/2·NCT07384624·30 enrolled

Hazardous and Harmful Alcohol Use1 trial

Topiramate Treatment of Hazardous and Harmful Alcohol Use in Veterans With TBI

Completed·UUniversity of California, San Francisco·Phase 4·NCT01750268·32 enrolled

Sciatica1 trial

Topiramate in the Treatment of Sciatica

Completed·NNational Institute of Dental and Craniofacial Research (NIDCR)·Phase 2·NCT00011804·65 enrolled

Peripheral Neuropathy1 trial

Topiramate for Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome (CSPN)

Completed·VVirginia Commonwealth University·Phase 2·NCT02878798·132 enrolled

Tics1 trial

The Evaluation of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of QDX in Healthy Korean Male Subjects

Completed·SSK Chemicals Co., Ltd.·Phase 1·NCT04401137·42 enrolled

Polyneuropathy1 trial

A Study To Evaluate The Effect Of Topiramate On Clinical And Electrophysiological Parameters In Subjects With Diabetic Peripheral Polyneuropathy

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 2·NCT00231673·72 enrolled

Encephalopathy1 trial

Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy

Terminated·KKristin R Hoffman·Phase 1/2·NCT01765218·34 enrolled

Obesity, Childhood1 trial

Pharmacokinetics and Pharmacodynamics of Topiramate for Weight Loss in Youth: PHARMATOP

Completed·UUniversity of Minnesota·Phase 1·NCT04986631·65 enrolled

Lactating Women on Select DOI1 trial

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Recruiting·DDuke University··NCT03511118·1,600 enrolled

Unspecified3 trials

Pharmacovigilance in Gerontopsychiatric Patients

Terminated·HHannover Medical School·Phase 3·NCT02374567·407 enrolled

Relationship Between Topiramate Use and Ocular Angle Status

Unknown status·—·Phase 4·NCT00153699·15 enrolled

Topiramate's Effects on Heavy Drinking

Terminated·UUniversity of Pennsylvania·Phase 2·NCT02074904·1 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 24, 1996

TOPAMAX

NDA NDA020505

Oct 26, 1998

TOPAMAX

NDA NDA020844

Aug 16, 2013

TROKENDI XR

NDA NDA201635

Mar 11, 2014

QUDEXY XR

NDA NDA205122

Nov 5, 2021

EPRONTIA

NDA NDA214679

Sources

References

[1]
ClinicalTrials.gov — 198 trial records for topiramate. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Topamax drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — topiramate compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for topiramate. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA214679). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Topamax. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Wim Janssens company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Glutamate Receptor Ionotropic AMPA Antagonist; Glutamate Receptor Ionotropic Kainate Antagonist; Sodium Channel Alpha Subunit Blocker; Carbonic Anhydrase II Inhibitor; Carbonic Anhydrase IV Inhibitor; GABA-a Receptor; Anion Channel Positive Modulator[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: WWim Janssens

Patent Landscape[6]

Patent Cliff

Nov 16, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

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