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 Efficacy and Safety of Topiramate Treatment in Patients With Epilepsy

Phase 3
Completed
Conditions
First Posted Date
2005-12-19
Last Posted Date
2011-06-08
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
51
Registration Number
NCT00266591

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

Phase 2
Completed
Conditions
First Posted Date
2005-12-05
Last Posted Date
2011-05-17
Lead Sponsor
Janssen-Ortho Inc., Canada
Target Recruit Count
38
Registration Number
NCT00261469

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

Phase 3
Completed
Conditions
First Posted Date
2005-11-15
Last Posted Date
2010-04-28
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
211
Registration Number
NCT00253175

Topiramate in the Treatment of Pathological Gambling

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2005-10-28
Last Posted Date
2019-07-02
Lead Sponsor
Icahn School of Medicine at Mount Sinai
Target Recruit Count
42
Registration Number
NCT00245583
Locations
🇺🇸

Mount Sinai School of Medicine, New York, New York, United States

Efficacy of Topiramate for Weight Loss in Subjects With Metabolic Syndrome

First Posted Date
2005-10-25
Last Posted Date
2007-12-10
Lead Sponsor
Northeastern Ohio Universities College of Medicine
Target Recruit Count
90
Registration Number
NCT00243984
Locations
🇺🇸

Akron General Medical Center, Akron, Ohio, United States

🇺🇸

Forum Health/Northside Medical Center, Youngstown, Ohio, United States

🇺🇸

St. Elizabeth Health Center, Youngstown, Ohio, United States

and more 2 locations

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

Phase 3
Completed
Conditions
First Posted Date
2005-10-12
Last Posted Date
2011-06-08
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
90
Registration Number
NCT00236743

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

Phase 3
Completed
Conditions
First Posted Date
2005-10-12
Last Posted Date
2011-06-10
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
223
Registration Number
NCT00236496
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