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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

Efficacy and Safety Study of BOTOX® Compared to Topiramate for the Prevention of Chronic Migraine in Adults

Phase 4
Completed
Conditions
Migraine Disorders
Interventions
Biological: onabotulinumtoxinA
First Posted Date
2014-07-16
Last Posted Date
2018-06-07
Lead Sponsor
Allergan
Target Recruit Count
282
Registration Number
NCT02191579
Locations
🇺🇸

Kansas City Bone and Joint Clinic, Overland Park, Kansas, United States

🇺🇸

Newport Beach Clinical Research Associates, Inc., Newport Beach, California, United States

🇺🇸

California Headache and Balance Center, Fresno, California, United States

and more 29 locations

Trial of Nortriptyline and Topiramate in the Initial Treatment of Vestibular Migraine

Not Applicable
Terminated
Conditions
Migraine Disorders
Interventions
Behavioral: Diet Modification
First Posted Date
2014-06-23
Last Posted Date
2021-04-23
Lead Sponsor
St. Louis University
Target Recruit Count
35
Registration Number
NCT02169830
Locations
🇺🇸

Saint Louis University, Saint Louis, Missouri, United States

Topiramate Trial for Compulsive Buying

Phase 2
Completed
Conditions
Compulsive Shopping
Interventions
Behavioral: Cognitive restructuring intervention
First Posted Date
2014-05-14
Last Posted Date
2017-05-09
Lead Sponsor
University of Sao Paulo
Target Recruit Count
42
Registration Number
NCT02138058
Locations
🇧🇷

Associação Viver Bem, São Paulo, SP, Brazil

Topiramate's Effects on Heavy Drinking

Phase 2
Terminated
Conditions
Alcohol Drinking
Interventions
Drug: Placebo
First Posted Date
2014-02-28
Last Posted Date
2018-09-21
Lead Sponsor
University of Pennsylvania
Target Recruit Count
1
Registration Number
NCT02074904
Locations
🇺🇸

University of Pennsylvania Center for Studies of Addiction, Philadelphia, Pennsylvania, United States

Topiramate: Long-Term Maintenance of Weight Loss Induced by Low-Calorie Diet in Obese Subjects

Phase 4
Terminated
Conditions
Obesity
Interventions
First Posted Date
2014-01-20
Last Posted Date
2014-01-20
Lead Sponsor
University of Copenhagen
Target Recruit Count
701
Registration Number
NCT02040311
Locations
🇩🇰

Department of Human Nutrition, Frederiksberg, Denmark

Study of Human Non-Shivering Thermogenesis and Basal Metabolic Rate

First Posted Date
2013-09-25
Last Posted Date
2024-10-16
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Target Recruit Count
47
Registration Number
NCT01950520
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Characterizing and Predicting Drug Effects on Cognition

Phase 4
Completed
Conditions
Cognitive Deficits
Interventions
First Posted Date
2013-06-28
Last Posted Date
2019-12-17
Lead Sponsor
University of Minnesota
Target Recruit Count
60
Registration Number
NCT01889602
Locations
🇺🇸

University of Minnesota, Minneapolis, Minnesota, United States

Topiramate in Adolescents With Severe Obesity

Phase 2
Completed
Conditions
Obesity, Morbid
Obesity
Weight Loss
Interventions
Other: Placebo
First Posted Date
2013-05-21
Last Posted Date
2017-07-02
Lead Sponsor
University of Minnesota
Target Recruit Count
34
Registration Number
NCT01859013
Locations
🇺🇸

University of Minnesota, Minneapolis, Minnesota, United States

Topiramate Trial for Pathological Gamblers

Phase 2
Completed
Conditions
Pathological Gambling
Interventions
Drug: Placebo matching tablets
Behavioral: 4-session gambling cognitive restructuring
First Posted Date
2013-05-01
Last Posted Date
2013-05-03
Lead Sponsor
University of Sao Paulo
Target Recruit Count
38
Registration Number
NCT01843699
Locations
🇧🇷

Instituto de Psiquiatria da Universidade de São Paulo, São Paulo, Brazil

Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence

Phase 2
Completed
Conditions
Cocaine Dependence
Interventions
Drug: Adderall-ER
Other: Placebo
First Posted Date
2013-03-15
Last Posted Date
2019-04-24
Lead Sponsor
New York State Psychiatric Institute
Target Recruit Count
169
Registration Number
NCT01811940
Locations
🇺🇸

STARS, New York, New York, United States

🇺🇸

University of Pennsylvania, Philadelphia, Pennsylvania, United States

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