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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

Generating Evidence on NonEpileptic, Stereotypical and Intermittent Symptoms (NESIS) in Chronic Subdural Hematomas

Phase 4
Recruiting
Conditions
Chronic Subdural Hematoma
Epilepsy; Seizure
Nonepileptic, Stereotypical and Intermittent Symptoms
Cortical Depression; Cortical Depolarization
NESIS
Interventions
First Posted Date
2021-02-18
Last Posted Date
2021-04-30
Lead Sponsor
Université de Sherbrooke
Target Recruit Count
56
Registration Number
NCT04759196
Locations
🇨🇦

Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada

Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old

Phase 4
Recruiting
Conditions
Migraine Disorders
Interventions
Drug: Placebo
First Posted Date
2021-02-10
Last Posted Date
2025-01-27
Lead Sponsor
Upsher-Smith Laboratories
Target Recruit Count
132
Registration Number
NCT04748601
Locations
🇺🇸

Upsher-Smith Clinical Trial Site #5, Birmingham, Alabama, United States

🇺🇸

Upsher-Smith Clinical Trial Site #15, La Jolla, California, United States

🇺🇸

Upsher-Smith Clinical Trials Site #3, Aurora, Colorado, United States

and more 12 locations

Beneficial Side Effects of Topiramate in Obese Patients Undergoing Total Joint Arthroplasty

Early Phase 1
Withdrawn
Conditions
Weight Loss
Pain, Postoperative
Interventions
First Posted Date
2020-11-03
Last Posted Date
2025-04-11
Lead Sponsor
Stanford University
Registration Number
NCT04613024
Locations
🇺🇲

Stanford University, Palo Alto, United States Minor Outlying Islands

Medications After Adolescent Bariatric Surgery

Phase 2
Withdrawn
Conditions
Pediatric Obesity
Interventions
First Posted Date
2020-10-01
Last Posted Date
2022-05-26
Lead Sponsor
Janey Pratt
Registration Number
NCT04572217
Locations
🇺🇸

Stanford University, Palo Alto, California, United States

Treatment of Obesity With Topiramate in Patients With Polycystic Ovary Syndrome

Phase 4
Conditions
Polycystic Ovary Syndrome
Hyperandrogenism
Obesity
Interventions
Drug: Placebo
First Posted Date
2020-07-01
Last Posted Date
2020-07-01
Lead Sponsor
Hospital de Clinicas de Porto Alegre
Target Recruit Count
80
Registration Number
NCT04453306
Locations
🇧🇷

Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil

The Evaluation of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of QDX in Healthy Korean Male Subjects

Phase 1
Completed
Conditions
Migraine
Interventions
First Posted Date
2020-05-26
Last Posted Date
2020-10-27
Lead Sponsor
SK Chemicals Co., Ltd.
Target Recruit Count
42
Registration Number
NCT04401137
Locations
🇰🇷

Seoul National University Hospital, Dept. of Clinical Pharmacology, Seoul, Korea, Republic of

Study on the Optimal Strategy of Chinese Patients With Bulimia Nervosa After Fluoxetine Treatment

Not Applicable
Conditions
Fluoxetine
Interventions
Behavioral: dialectical behavior therapy (DBT)
Behavioral: cognitive behavioral therapy (CBT)
First Posted Date
2019-11-07
Last Posted Date
2021-09-16
Lead Sponsor
Shanghai Mental Health Center
Target Recruit Count
550
Registration Number
NCT04154813
Locations
🇨🇳

Shanghai Mental Health Center, Shanghai, Shanghai, China

Adjunct Phentermine + Topiramate After Bariatric Surgery in 12-24 Year Olds

Phase 2
Completed
Conditions
Bariatric Surgery
Young Adult
Obesity, Morbid
Adolescent
Drug Therapy
Interventions
First Posted Date
2019-09-19
Last Posted Date
2022-03-09
Lead Sponsor
Jaime Moore, MD MPH
Target Recruit Count
13
Registration Number
NCT04095104
Locations
🇺🇸

Children's Hospital Colorado, Aurora, Colorado, United States

Therapy for Migraine Prevention in Children 6-11 Years of Age

Phase 4
Terminated
Conditions
Migraine Disorders
Headache Disorders
Interventions
Drug: Placebo
First Posted Date
2019-08-08
Last Posted Date
2024-08-09
Lead Sponsor
Supernus Pharmaceuticals, Inc.
Target Recruit Count
26
Registration Number
NCT04050293
Locations
🇺🇸

CNS Healthcare, Memphis, Tennessee, United States

SMART Use of Medication for the Treatment of Adolescent Severe Obesity

Phase 2
Active, not recruiting
Conditions
Adolescent Obesity
Interventions
Behavioral: Lifestyle Modification Therapy (LSMT)
First Posted Date
2019-07-05
Last Posted Date
2025-03-13
Lead Sponsor
University of Minnesota
Target Recruit Count
150
Registration Number
NCT04007393
Locations
🇺🇸

University of Minnesota, Minneapolis, Minnesota, United States

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