MedPath

Topiramate

Generic Name
Topiramate
Brand Names
Eprontia, Qsymia, Qudexy, Topamax, Trokendi
Drug Type
Small Molecule
Chemical Formula
C12H21NO8S
CAS Number
97240-79-4
Unique Ingredient Identifier
0H73WJJ391
Background

Topiramate is a anti-epileptic drug used to manage seizures and prevent migraines. It was initially approved by the FDA in 1996. In 2004, topiramate was approved for the prevention of migraine in adults. Since 2012, the extended-release formulation has been approved in combination with phentermine for chronic weight management therapy in adults.

Characteristics that distinguish topiramate from other antiepileptic drugs are a monosaccharide chemical structure containing a sulfamate, and 40% of its mass accounted for by oxygen. Interestingly, topiramate was discovered by chance when attempts were made to formulate a novel antidiabetic drug.

Indication

Topiramate is indicated for the following conditions: 1)Monotherapy for partial onset or primary generalized tonic-clonic seizures for patients 2 years of age and above 2)Adjunctive therapy for partial onset seizures or primary generalized tonic-clonic seizures for both adult and pediatric patients above 2 years old 3)Adjunctive therapy for seizures associated with Lennox-Gastaut syndrome in patients above 2 years of age 4)Prophylaxis of migraine in children 12 years of age and older and adults.

Topiramate is also used off-label as an adjunct therapy for weight management and for mood disorders.

Associated Conditions
Alcohol Dependency, Epilepsy, Primary Generalized Tonic-Clonic Seizures, Generalized Tonic-Clonic Seizures, Lennox-Gastaut Syndrome, Migraine, Moods Disorders, Partial-Onset Seizures, Seizures, Weight
Associated Therapies
Chronic Weight Management therapy, Weight Reduction

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

Phase 3
Completed
Conditions
Obesity
Diabetes Mellitus, Type 2
Diabetes Mellitus, Adult-Onset
First Posted Date
2005-10-04
Last Posted Date
2011-06-08
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
541
Registration Number
NCT00231530

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

Phase 3
Terminated
Conditions
Obesity
Diabetes Mellitus, Type 2
Diabetes Mellitus, Adult-Onset
First Posted Date
2005-10-04
Last Posted Date
2011-06-08
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
31
Registration Number
NCT00231634

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

Phase 2
Completed
Conditions
Obesity
First Posted Date
2005-10-04
Last Posted Date
2011-06-08
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
68
Registration Number
NCT00231608

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

Phase 3
Terminated
Conditions
Obesity
Hyperlipidemia
Hypertriglyceridemia
First Posted Date
2005-10-04
Last Posted Date
2011-06-08
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
179
Registration Number
NCT00231621

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

Phase 2
Completed
Conditions
Obesity
Diabetes Mellitus, Type 2
Diabetes Mellitus, Adult-Onset
First Posted Date
2005-10-04
Last Posted Date
2011-06-08
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
113
Registration Number
NCT00231647

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

Phase 3
Completed
Conditions
Migraine
Common Migraine
Classic Migraine
Headache
First Posted Date
2005-10-04
Last Posted Date
2010-11-19
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
768
Registration Number
NCT00231595

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

Phase 3
Completed
Conditions
Epilepsies, Partial
Epilepsy
Seizures
Epilepsy, Tonic-Clonic
Epilepsy, Generalized
First Posted Date
2005-10-04
Last Posted Date
2011-06-08
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
750
Registration Number
NCT00231556

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

Phase 3
Completed
Conditions
Epilepsy
Epilepsies, Partial
Seizures
First Posted Date
2005-10-03
Last Posted Date
2010-11-15
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
451
Registration Number
NCT00230698

Topiramate to Reduce Cocaine Dependence

Phase 2
Completed
Conditions
Cocaine-Related Disorders
Interventions
First Posted Date
2005-09-22
Last Posted Date
2012-04-19
Lead Sponsor
Bankole Johnson
Target Recruit Count
25
Registration Number
NCT00223626
Locations
🇺🇸

University of Virginia CARE Center for Addiction Research & Education, Charlottesville, Virginia, United States

🇺🇸

UVA CARE Richmond, Richmond, Virginia, United States

Safety and Efficacy Study of Topiramate to Aid in Smoking Cessation

Phase 3
Completed
Conditions
Smoking Cessation
Interventions
Drug: Topiramate
Drug: Placebo
First Posted Date
2005-09-22
Last Posted Date
2012-04-13
Lead Sponsor
Lindner Center of HOPE
Target Recruit Count
87
Registration Number
NCT00280839
Locations
🇺🇸

University of Cincinnati Medical Center, Cincinnati, Ohio, United States

© Copyright 2025. All Rights Reserved by MedPath