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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

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

Phase 3
Completed
Conditions
Obsessive-Compulsive Disorder
First Posted Date
2005-09-16
Last Posted Date
2011-10-05
Lead Sponsor
University of Florida
Target Recruit Count
96
Registration Number
NCT00187928
Locations
🇺🇸

UF Health Science Center, Gainesville, Florida, United States

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

Phase 4
Completed
Conditions
Obsessive Compulsive Disorder
Interventions
Drug: placebo
First Posted Date
2005-09-16
Last Posted Date
2020-09-01
Lead Sponsor
McMaster University
Target Recruit Count
23
Registration Number
NCT00182520
Locations
🇨🇦

MacAnxiety Research Centre, Hamilton, Ontario, Canada

Topiramate for Alcohol and Cocaine Dependence

Phase 2
Completed
Conditions
Alcoholism
Cocaine Dependence
Interventions
Drug: placebo
First Posted Date
2005-09-14
Last Posted Date
2020-07-07
Lead Sponsor
Kyle Kampman
Target Recruit Count
170
Registration Number
NCT00167245
Locations
🇺🇸

University of Pennsylvania, Treatment Research Center, Philadelphia, Pennsylvania, United States

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

Phase 4
Completed
Conditions
Epilepsy
Interventions
First Posted Date
2005-09-12
Last Posted Date
2009-09-02
Lead Sponsor
Eisai Korea Inc.
Target Recruit Count
140
Registration Number
NCT00154076
Locations
🇰🇷

Daegu Catholic University Medical Center, Daegu, Korea, Republic of

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

Phase 2
Completed
Conditions
Basilar Migraine
First Posted Date
2005-09-12
Last Posted Date
2007-04-05
Lead Sponsor
Monarch Medical Research
Target Recruit Count
40
Registration Number
NCT00158002
Locations
🇺🇸

Monarch Medical Research - Child and Adolescent Neurology, Norfolk, Virginia, United States

Relationship Between Topiramate Use and Ocular Angle Status

Phase 4
Conditions
Glaucoma, Angle-Closure
First Posted Date
2005-09-12
Last Posted Date
2007-10-31
Lead Sponsor
Chinese University of Hong Kong
Target Recruit Count
15
Registration Number
NCT00153699
Locations
🇭🇰

Hong Kong Eye Hospital, Kowloon, Hong Kong

🇭🇰

Prince of Wales Hospital, Shatin, Hong Kong

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

Phase 2
Completed
Conditions
Basilar Migraine
First Posted Date
2005-08-18
Last Posted Date
2012-11-12
Lead Sponsor
Monarch Medical Research
Target Recruit Count
40
Registration Number
NCT00131443
Locations
🇺🇸

Monarch Medical Research - Child and Adolescent Neurology, Norfolk, Virginia, United States

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

Phase 3
Completed
Conditions
Partial Seizure Disorder
Epilepsy
Seizures
Interventions
Drug: placebo
First Posted Date
2005-06-13
Last Posted Date
2014-03-26
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
118
Registration Number
NCT00113815

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

Not Applicable
Completed
Conditions
Prader-Willi Syndrome
Self-Injurious Behavior
First Posted Date
2003-08-05
Last Posted Date
2013-05-01
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Target Recruit Count
10
Registration Number
NCT00065923
Locations
🇺🇸

University of Florida-Brain Institute, Gainesville, Florida, United States

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
2002-05-21
Last Posted Date
2011-05-18
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
434
Registration Number
NCT00037674
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