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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

Comparing the Safety and Effectiveness of Topiramate With the Safety and Effectiveness of Amitriptyline in Preventing Migraine Headaches

Phase 3
Completed
Conditions
Migraine
Headache
First Posted Date
2005-09-21
Last Posted Date
2011-06-10
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
347
Registration Number
NCT00210821

An Efficacy and Safety Study of Topiramate in the Treatment of Alcohol Dependence

Phase 2
Completed
Conditions
Alcoholism
First Posted Date
2005-09-21
Last Posted Date
2011-06-08
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
371
Registration Number
NCT00210925

Evaluation of the Effectiveness of Topiramate in Preventing the Transformation From Episodic Migraine to Chronic Daily Headache.

Phase 4
Completed
Conditions
Migraine
Headache
Classic Migraine
Common Migraine
First Posted Date
2005-09-21
Last Posted Date
2011-05-19
Lead Sponsor
Ortho-McNeil Neurologics, Inc.
Target Recruit Count
385
Registration Number
NCT00212810

Topiramate in the Treatment of Posttraumatic Stress Disorder in Civilians

Phase 4
Completed
Conditions
Post-Traumatic Stress Disorder
First Posted Date
2005-09-21
Last Posted Date
2009-04-29
Lead Sponsor
Creighton University
Target Recruit Count
60
Registration Number
NCT00208130
Locations
🇺🇸

Creighton University Psychiatry and Research Center, Omaha, Nebraska, United States

Topiramate Augmentation in the Treatment of Obsessive-Compulsive Disorder

Phase 4
Completed
Conditions
Obsessive-compulsive Disorder
First Posted Date
2005-09-21
Last Posted Date
2018-05-30
Lead Sponsor
Montefiore Medical Center
Target Recruit Count
24
Registration Number
NCT00211744
Locations
🇺🇸

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

A Double-Blind, Placebo-Controlled Study Examining the Use of Topiramate in the Treatment of Cluster Headache

Phase 4
Terminated
Conditions
Cluster Headache
First Posted Date
2005-09-20
Last Posted Date
2009-01-23
Lead Sponsor
Thomas Jefferson University
Target Recruit Count
60
Registration Number
NCT00203190
Locations
🇺🇸

Jefferson Headache Center, Philadelphia, Pennsylvania, United States

Topiramate in the Treatment of Post Traumatic Stress Disorder (PTSD)

Phase 4
Completed
Conditions
PTSD
First Posted Date
2005-09-20
Last Posted Date
2009-07-29
Lead Sponsor
Tuscaloosa Research & Education Advancement Corporation
Target Recruit Count
40
Registration Number
NCT00203463
Locations
🇺🇸

Tuscaloosa Research & Education Advancement Corporation, Tuscaloosa, Alabama, United States

Safety & Efficacy Study Using Topiramate in Posttraumatic Stress Disorder

Phase 2
Completed
Conditions
Posttraumatic Stress Disorder
First Posted Date
2005-09-20
Last Posted Date
2007-05-30
Lead Sponsor
University of Oklahoma
Target Recruit Count
50
Registration Number
NCT00204386
Locations
🇺🇸

The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

Efficacy and Safety Study of Topiramate to Treat Restless Legs Syndrome

Phase 4
Completed
Conditions
Restless Legs Syndrome
First Posted Date
2005-09-20
Last Posted Date
2005-12-16
Lead Sponsor
Neurocare
Target Recruit Count
44
Registration Number
NCT00200941
Locations
🇺🇸

Neurocare, Newton, Massachusetts, United States

Efficacy of Adding Topiramate to Current Treatment in Treatment-Resistant Generalized Social Phobia (GSP)

Phase 4
Terminated
Conditions
Social Phobia
Interventions
Drug: Placebo
First Posted Date
2005-09-16
Last Posted Date
2020-09-02
Lead Sponsor
McMaster University
Target Recruit Count
12
Registration Number
NCT00182455
Locations
🇨🇦

MacAnxiety Research Centre, Hamilton, Ontario, Canada

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