MedPath

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

Phentermine/Topiramate as Preventive Pharmacotherapy for Obesity

Phase 2
Withdrawn
Conditions
Obesity, Adolescent
Interventions
Behavioral: Placebo and lifestyle management therapy
First Posted Date
2023-04-28
Last Posted Date
2023-10-26
Lead Sponsor
University of Minnesota
Registration Number
NCT05834062
Locations
🇺🇸

University of Minnesota, Minneapolis, Minnesota, United States

Topiramate, Amitriptyline Monotherapy and Combination Therapy in Migraine Prophylaxis

First Posted Date
2023-03-08
Last Posted Date
2023-03-08
Lead Sponsor
Dr. Reaz Mahmud
Target Recruit Count
150
Registration Number
NCT05759845
Locations
🇧🇩

Dhaka Medical College, Dhaka, Bangladesh

Anti-obesity Pharmacotherapy and Inflammation

Active, not recruiting
Conditions
Obesity
Interventions
First Posted Date
2023-03-06
Last Posted Date
2025-01-10
Lead Sponsor
Louisiana State University Health Sciences Center in New Orleans
Target Recruit Count
30
Registration Number
NCT05756764
Locations
🇺🇸

LSU Clinical & Translational Research Center (CTRC - - LSUHSC-NO, New Orleans, Louisiana, United States

🇺🇸

Ochsner Health System - Biospecimen, New Orleans, Louisiana, United States

Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine

Phase 3
Active, not recruiting
Conditions
Migraine
Interventions
First Posted Date
2023-02-28
Last Posted Date
2024-11-22
Lead Sponsor
AbbVie
Target Recruit Count
545
Registration Number
NCT05748483
Locations
🇨🇿

Praglandia /ID# 247511, Prague, Praha 5, Czechia

🇩🇪

Universitaetsklinikum Carl Gustav Carus Dresden /ID# 246040, Dresden, Sachsen, Germany

🇧🇪

Universitair Ziekenhuis Brussel /ID# 246959, Jette, Bruxelles-Capitale, Belgium

and more 78 locations

Topiramate vs Metformin on Cardio-Metabolic Profile in Schizophrenia on Atypical Antipsychotics

Phase 4
Completed
Conditions
Metabolic Syndrome
Schizophrenia
Interventions
First Posted Date
2022-12-23
Last Posted Date
2023-08-22
Lead Sponsor
All India Institute of Medical Sciences, Bhubaneswar
Target Recruit Count
60
Registration Number
NCT05663749
Locations
🇮🇳

Dept of Psychiatry, Aiims, Bhubaneswar, Bhubaneswar, Odisha, India

Transcutaneous Supraorbital Nerve Stimulator Versus Topiramate in Prevention of Recurrent Migraine

Not Applicable
Conditions
Migraine, Classic
Interventions
Device: Transcutaneous Supraorbital Nerve Stimulator
First Posted Date
2022-08-25
Last Posted Date
2022-08-25
Lead Sponsor
Tongji Hospital
Target Recruit Count
200
Registration Number
NCT05516251
Locations
🇨🇳

Wensheng Qu, Wuhan, Hubei, China

The Role of Migraine Prophylaxis Agent Topiramate in Treating Patients With Sudden Sensorineural Hearing Loss

Phase 2
Recruiting
Conditions
Sudden Sensorineural Hearing Loss
Sudden Deafness
Interventions
Drug: Systemic Steroids
First Posted Date
2022-06-03
Last Posted Date
2024-02-16
Lead Sponsor
Chang Gung Memorial Hospital
Target Recruit Count
140
Registration Number
NCT05403229
Locations
🇨🇳

New Taipei Municipal Tucheng Hospital, New Taipei City, Taiwan

Phase IV Study of Qsymia in Obese Patients

First Posted Date
2022-05-18
Last Posted Date
2024-01-31
Lead Sponsor
Alvogen Korea
Target Recruit Count
232
Registration Number
NCT05378503
Locations
🇰🇷

The Catholic Univ. of Korea Bucheon St. Mary's Hospital, Bucheon, Gyeonggi-do, Korea, Republic of

🇰🇷

Hanyang Univ. Guri Hospital, Guri-si, Gyeonggi-do, Korea, Republic of

🇰🇷

Sejong Hospital, Bucheon-si, Gyeonggi-do, Korea, Republic of

and more 5 locations

A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects

Phase 4
Completed
Conditions
Blood Pressure
Interventions
First Posted Date
2022-01-31
Last Posted Date
2024-07-17
Lead Sponsor
VIVUS LLC
Target Recruit Count
565
Registration Number
NCT05215418
Locations
🇺🇸

Clinical Site, Norfolk, Virginia, United States

🇺🇸

Clinical site, Salt Lake City, Utah, United States

Pharmacokinetics and Pharmacodynamics of Topiramate for Weight Loss in Youth: PHARMATOP

Early Phase 1
Active, not recruiting
Conditions
Obesity, Childhood
Interventions
First Posted Date
2021-08-03
Last Posted Date
2025-03-13
Lead Sponsor
University of Minnesota
Target Recruit Count
65
Registration Number
NCT04986631
Locations
🇺🇸

University of Minnesota, Minneapolis, Minnesota, United States

© Copyright 2025. All Rights Reserved by MedPath