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

Phase 3
Completed
Conditions
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Interventions
Drug: Placebo
First Posted Date
2002-05-07
Last Posted Date
2011-06-27
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
13
Registration Number
NCT00035802

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

Phase 3
Completed
Conditions
Bipolar Disorder
First Posted Date
2002-05-03
Last Posted Date
2011-06-08
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
338
Registration Number
NCT00035230

Topiramate in the Treatment of Sciatica

Phase 2
Completed
Conditions
Sciatica
First Posted Date
2001-03-01
Last Posted Date
2008-03-04
Lead Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
Target Recruit Count
65
Registration Number
NCT00011804
Locations
🇺🇸

National Institute of Dental And Craniofacial Research (NIDCR), Bethesda, Maryland, United States

Alcohol Dependency Study: Combining Medication Treatment for Alcoholism

First Posted Date
2000-09-12
Last Posted Date
2013-03-15
Lead Sponsor
Bankole Johnson
Target Recruit Count
320
Registration Number
NCT00006205
Locations
🇺🇸

University of Virginia Center for Addiction Research and Education, Richmond, Virginia, United States

Study of the Pathogenesis of Rett Syndrome

Not Applicable
Completed
Conditions
Rett Syndrome
First Posted Date
2000-02-25
Last Posted Date
2005-06-24
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Target Recruit Count
120
Registration Number
NCT00004807

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

Phase 3
Completed
Conditions
Lennox-Gastaut Syndrome
First Posted Date
2000-02-25
Last Posted Date
2005-06-24
Lead Sponsor
National Center for Research Resources (NCRR)
Target Recruit Count
10
Registration Number
NCT00004776
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