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 in the Treatment of Patients With Difficult to Control Epilepsy

Phase 2
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
178
Registration Number
NCT00236730

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

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
80
Registration Number
NCT00236418

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

Phase 2
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
60
Registration Number
NCT00236847

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

Phase 3
Completed
Conditions
First Posted Date
2005-10-12
Last Posted Date
2011-06-03
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
100
Registration Number
NCT00236756

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

Phase 3
Completed
Conditions
First Posted Date
2005-10-12
Last Posted Date
2011-05-19
Lead Sponsor
Ortho-McNeil Neurologics, Inc.
Target Recruit Count
287
Registration Number
NCT00237289

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

Phase 3
Completed
Conditions
First Posted Date
2005-10-12
Last Posted Date
2011-05-19
Lead Sponsor
Ortho-McNeil Neurologics, Inc.
Target Recruit Count
162
Registration Number
NCT00237302

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

First Posted Date
2005-10-12
Last Posted Date
2010-11-17
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
763
Registration Number
NCT00236509
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