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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

First Add-on vs. Mono-therapy Study of Topiramate in Neuro-Surgical Patients

Phase 4
Completed
Conditions
Epilepsy
Interventions
First Posted Date
2012-06-26
Last Posted Date
2013-10-29
Lead Sponsor
Johnson & Johnson Taiwan Ltd
Target Recruit Count
55
Registration Number
NCT01627860

The Childhood and Adolescent Migraine Prevention Study

Phase 3
Terminated
Conditions
Migraine
Migraine Disorders
Headache
Interventions
First Posted Date
2012-04-20
Last Posted Date
2017-08-10
Lead Sponsor
Children's Hospital Medical Center, Cincinnati
Target Recruit Count
488
Registration Number
NCT01581281
Locations
🇺🇸

University of Maryland School of Medicine, Baltimore, Maryland, United States

🇺🇸

University of Nevada, Reno, Nevada, United States

🇺🇸

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

and more 32 locations

Topiramate Bioequivalence Study Brazil - Fast

Phase 1
Completed
Conditions
Epilepsy, Tonic-Clonic
Interventions
First Posted Date
2011-09-23
Last Posted Date
2017-06-28
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
26
Registration Number
NCT01439438
Locations
🇧🇷

GSK Investigational Site, Campinas, São Paulo, Brazil

Preventing Brain Injury in Infants With Congenital Heart Disease

Phase 1
Completed
Conditions
Cyanotic Congenital Heart Disease
Interventions
Other: No medication, but routine heart surgery
First Posted Date
2011-08-31
Last Posted Date
2019-02-08
Lead Sponsor
University of California, Davis
Target Recruit Count
24
Registration Number
NCT01426542
Locations
🇺🇸

UC Davis Children's Hospital, Sacramento, California, United States

Topiramate for Alcohol Use in Posttraumatic Stress Disorder

Not Applicable
Terminated
Conditions
Alcohol Dependence
Alcoholism
Alcohol Abuse
Alcohol Use Disorder
Posttraumatic Stress Disorder
PTSD
Interventions
Drug: Placebo
First Posted Date
2011-08-03
Last Posted Date
2022-03-03
Lead Sponsor
University of Maryland, Baltimore
Target Recruit Count
4
Registration Number
NCT01408641
Locations
🇺🇸

Baltimore VA, VA Maryland Health Care System, Baltimore, Maryland, United States

The Therapeutic Effects of Topiramate and Metformin on Second Generation Antipsychotics-induced Obesity

Not Applicable
Completed
Conditions
Obesity
Interventions
First Posted Date
2011-06-29
Last Posted Date
2012-02-24
Lead Sponsor
Beitou Armed Forces Hospital, Taipei, Taiwan
Target Recruit Count
25
Registration Number
NCT01384279
Locations
🇨🇳

Beitou Armed Forces Hospital, Taipei, Taiwan

Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With Obesity

Phase 2
Terminated
Conditions
Metabolic Syndrome X
Obesity
Interventions
First Posted Date
2011-05-11
Last Posted Date
2021-06-09
Lead Sponsor
University of Iowa
Target Recruit Count
136
Registration Number
NCT01351753
Locations
🇺🇸

University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States

Evaluation of the Pharmacokinetics, Safety, and Tolerability of TPM XR as Adjunctive Therapy in Pediatric Subjects With Epilepsy

Phase 1
Completed
Conditions
Epilepsy
Interventions
First Posted Date
2011-01-27
Last Posted Date
2016-06-02
Lead Sponsor
Supernus Pharmaceuticals, Inc.
Target Recruit Count
30
Registration Number
NCT01284530

Safety and Efficacy of Topiramate in Neonates With Hypoxic Ischemic Encephalopathy Treated With Hypothermia

Phase 2
Completed
Conditions
Hypoxic Ischemic Encephalopathy
Interventions
First Posted Date
2010-11-16
Last Posted Date
2013-12-13
Lead Sponsor
Azienda Ospedaliero, Universitaria Meyer
Target Recruit Count
64
Registration Number
NCT01241019
Locations
🇮🇹

Neonatal Intensive Care Unit - Azienda Ospedaliero-Universitaria Meyer, Florence, Italy

🇮🇹

Neonatal Intensive Care Unit - Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy

Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures

Phase 4
Completed
Conditions
Epilepsy
Interventions
First Posted Date
2010-10-28
Last Posted Date
2017-08-15
Lead Sponsor
UCB Korea Co., Ltd.
Target Recruit Count
343
Registration Number
NCT01229735
Locations
🇰🇷

18, Seoul, Korea, Republic of

🇰🇷

13, Daegu, Korea, Republic of

🇰🇷

23, Kyunggi-Do, Korea, Republic of

and more 21 locations
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