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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

Flunarizine Versus Topiramate for Chronic Migraine Prophylaxis

Phase 4
Completed
Conditions
Chronic Migraine
Interventions
First Posted Date
2015-12-24
Last Posted Date
2015-12-24
Lead Sponsor
Taipei Veterans General Hospital, Taiwan
Target Recruit Count
62
Registration Number
NCT02639598

Topiramate and Cerebrovascular Response in Migraineurs

Phase 4
Completed
Conditions
Migraine Disorders
Interventions
First Posted Date
2015-04-23
Last Posted Date
2015-04-23
Lead Sponsor
SMG-SNU Boramae Medical Center
Target Recruit Count
19
Registration Number
NCT02424318

Prospective Analgesic Compound Efficacy (PACE) Study

Completed
Conditions
Radiculopathy
Gout
Muscle Spasms
Headache
Arthritis
Synovitis
Migraine
Tendonitis
First Posted Date
2015-03-31
Last Posted Date
2018-02-01
Lead Sponsor
Express Specialty Pharmacy
Target Recruit Count
300
Registration Number
NCT02403687

Pharmacovigilance in Gerontopsychiatric Patients

Phase 3
Terminated
Conditions
Dementia
Depression
Schizophrenia
Psychosomatic Disorders
Anxiety Disorders
Interventions
First Posted Date
2015-03-02
Last Posted Date
2018-02-28
Lead Sponsor
Hannover Medical School
Target Recruit Count
407
Registration Number
NCT02374567
Locations
🇩🇪

Bezirkskrankenhaus Augsburg, Augsburg, Germany

🇩🇪

Krankenhaus Hedwigshöhe, Berlin, Germany

🇩🇪

Hannover Medical School, Hannover, Germany

and more 2 locations

A Randomized, Double-blind Placebo-Controlled Pharmacogenetic Study of Topiramate in European-American Heavy Drinkers

Phase 2
Completed
Conditions
Alcohol Use Disorder (AUD)
Alcoholism
Interventions
Behavioral: Medical Management
Drug: Inactive Placebo
First Posted Date
2015-02-26
Last Posted Date
2022-01-20
Lead Sponsor
University of Pennsylvania
Target Recruit Count
320
Registration Number
NCT02371889
Locations
🇺🇸

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

🇺🇸

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

A Open-label, Drug Interaction Study Between Eslicarbazepine Acetate and Topiramate

Phase 1
Completed
Conditions
Epilepsy
Interventions
First Posted Date
2014-11-05
Last Posted Date
2025-04-11
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
32
Registration Number
NCT02283814

Topiramate and Severe Obesity

Phase 3
Completed
Conditions
Obese Children and Adolescents
Interventions
Drug: Placebo
First Posted Date
2014-10-24
Last Posted Date
2019-02-19
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
18
Registration Number
NCT02273804
Locations
🇫🇷

Hopital Bicêtre, Le Kremlin-Bicêtre, Paris, France

Topiramate-Phentermine Combinations for Cocaine Dependence

Phase 1
Completed
Conditions
Cocaine Use Disorder
Interventions
First Posted Date
2014-09-15
Last Posted Date
2019-11-27
Lead Sponsor
University of Kentucky
Target Recruit Count
38
Registration Number
NCT02239913
Locations
🇺🇸

University of Kentucky Medical Center, Lexington, Kentucky, United States

Effect of VI-0521 (Qsymia®) on Glomerular Filtration Rate (GFR) in Overweight or Obese Healthy Subjects

Phase 4
Completed
Conditions
Obesity
Interventions
Drug: Placebo
First Posted Date
2014-09-01
Last Posted Date
2017-11-07
Lead Sponsor
VIVUS LLC
Target Recruit Count
51
Registration Number
NCT02229214
Locations
🇺🇸

Research Center, Lakewood, Colorado, United States

A Study to Investigate the Safety of the Drugs Topiramate and Levetiracetam in Treating Children Recently Diagnosed With Epilepsy

Phase 3
Completed
Conditions
Epilepsy
Interventions
First Posted Date
2014-07-28
Last Posted Date
2025-04-29
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
63
Registration Number
NCT02201251
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