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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

Topiramate and Prolonged Exposure

Phase 2
Completed
Conditions
PTSD and Alcohol Use Disorder
Interventions
Behavioral: prolonged exposure
Drug: placebo
First Posted Date
2017-06-06
Last Posted Date
2023-11-18
Lead Sponsor
VA Office of Research and Development
Target Recruit Count
100
Registration Number
NCT03176953
Locations
🇺🇸

VA San Diego Healthcare System, San Diego, CA, San Diego, California, United States

Topiramate Augmenting Strategies for the Treatment of Alcohol Use Disorder

Early Phase 1
Conditions
Alcoholism
Interventions
First Posted Date
2017-04-19
Last Posted Date
2020-10-27
Lead Sponsor
Nassima Ait-Daoud Tiouririne
Target Recruit Count
16
Registration Number
NCT03120468
Locations
🇺🇸

UVA Center for Leading Edge Addiction Research, Charlottesville, Virginia, United States

Topiramate Treatment of Alcohol Use Disorders in African Americans

Phase 4
Terminated
Conditions
Alcohol Use Disorder
Interventions
Drug: placebo
First Posted Date
2017-01-12
Last Posted Date
2023-03-23
Lead Sponsor
VA Office of Research and Development
Target Recruit Count
79
Registration Number
NCT03018704
Locations
🇺🇸

Atlanta VA Medical and Rehab Center, Decatur, GA, Decatur, Georgia, United States

🇺🇸

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, Philadelphia, Pennsylvania, United States

Physiologic Effects of Topiramate on Cognition

Phase 1
Completed
Conditions
Alteration of Cognitive Function
Interventions
Drug: Placebo
First Posted Date
2016-08-30
Last Posted Date
2017-01-11
Lead Sponsor
University of Florida
Target Recruit Count
11
Registration Number
NCT02884050

Topiramate for Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome (CSPN)

Phase 2
Completed
Conditions
Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome
Interventions
Other: Placebo
First Posted Date
2016-08-25
Last Posted Date
2023-11-14
Lead Sponsor
Virginia Commonwealth University
Target Recruit Count
132
Registration Number
NCT02878798
Locations
🇺🇸

Vanderbilt University Medical Center, Nashville, Tennessee, United States

🇺🇸

Virginia Commonwealth University, Richmond, Virginia, United States

🇺🇸

University of Miami, Miami, Florida, United States

and more 17 locations

Study of the Efficacy of Topiramate in Patients With Prader Willi Syndrome Over 8 Weeks

Phase 3
Terminated
Conditions
Prader-Willi Syndrome
Interventions
Drug: Placebo Comparator
First Posted Date
2016-06-23
Last Posted Date
2018-04-11
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
69
Registration Number
NCT02810483
Locations
🇫🇷

Hôpital La Pitié Salpêtrière, Paris, France

Topiramate and Schizophrenia: Effects on Weight and Psychopathology

Not Applicable
Recruiting
Conditions
Schizophrenia, Schizoaffective Disorder
Interventions
Other: Placebo
First Posted Date
2016-06-21
Last Posted Date
2023-07-24
Lead Sponsor
Centre for Addiction and Mental Health
Target Recruit Count
50
Registration Number
NCT02808533
Locations
🇨🇦

Center for Addiction and Mental Health, Toronto, Ontario, Canada

Characterization of Epilepsy Patients BEEP 2b

First Posted Date
2016-03-14
Last Posted Date
2020-03-27
Lead Sponsor
Food and Drug Administration (FDA)
Target Recruit Count
21
Registration Number
NCT02707965
Locations
🇺🇸

University of Maryland, Baltimore, Baltimore, Maryland, United States

Efficacy and Safety of Danzhen

Phase 1
Conditions
Migraine
Interventions
Drug: Danzhen
First Posted Date
2016-01-01
Last Posted Date
2016-01-01
Lead Sponsor
Xijing Hospital
Target Recruit Count
3300
Registration Number
NCT02645370
Locations
🇨🇳

Xijing Hospital, Xi'an, Shanxi, China

Migraine Treatment in ED

Not Applicable
Withdrawn
Conditions
Migraine
Interventions
Behavioral: Relaxation Therapy
Drug: Standard of Care
Drug: Abortive Medication (Naproxen and Sumatriptan)
First Posted Date
2015-12-31
Last Posted Date
2018-08-24
Lead Sponsor
NYU Langone Health
Registration Number
NCT02643719
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