Prospective Pilot Study on Metabolism and Weight Changes in Topiramate-Treated Epilepsy Patients - Full Text View

Sponsor:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00236886

Purpose

The purpose of this study is to assess a possible predictor for weight loss seen in epilepsy patients treated with topiramate.

Condition	Intervention	Phase
Epilepsy Epilepsies, Partial Epilepsy, Generalized Seizures	Drug: topiramate	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Prospective Pilot Study on Metabolism and Weight Changes in Subjects With Diagnosed Partial Onset Epilepsy, With or Without Secondarily Generalized Seizures and Treated With Topiramate.

Resource links provided by NLM:

Genetics Home Reference related topics: autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures Weight Control

Drug Information available for: Topiramate

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

Metabolic test battery including Body Mass Index (BMI), lean body mass, blood lipids and fasting glucose along with physical examinations (including body weights) will be recorded at the beginning of the trial, after 3 months and after one year

Secondary Outcome Measures:

Safety evaluations (vital signs, physical exams, electrocardiogram, incidence and severity of adverse events) will be conducted throughout the study; Seizure frequency will be monitored throughout the study

Enrollment:	49
Study Start Date:	May 1998
Study Completion Date:	June 2000

Detailed Description:

Topiramate has been shown to be an effective anti-epileptic medication with a good safety profile. In clinical trials, some patients have experienced substantial weight loss. This prospective single center, open, pilot study will investigate whether there is any metabolic predictor for the weight loss. The patients will receive daily oral dose of topiramate in addition to anti-epileptic medications already prescribed by their physicians. A battery of metabolic tests including Body Mass Index (BMI), lean body mass, blood lipids and fasting glucose in tandem with other examinations will be taken before dispensing of topiramate, after 3 months and at the final visit. The study hypothesis is metabolic test results will provide a predictor of weight loss with topiramate. Patients will receive between 25 to 400mg daily of topiramate by mouth in addition to current anti-epileptic medications for up to 1 year. Dose will be adjusted (up to 1000 mg daily) by the investigators depending on the patients' clinical response.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

A diagnosis of partial onset epilepsy, with or without secondary generalization. Patients with a diagnosis of epilepsy characterized by primary generalized tonic-clonic seizures may also qualify
Currently taking one or more anti-epileptic medications on a stable dose for one month
Weight between 40 and 130 kg (88 to 286 lbs)
Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing an acceptable method of contraception (requires negative pregnancy test).

Exclusion Criteria:

Patients with rapidly progressive disorders that may impair their weight or their reliable participation in the study
Patients prone to severe malabsorption and/or metabolic disorders
Patients who have mental retardation or impairment which would confound the interpretation of this study
History (within the past six months) of a psychiatric or mood disorder requiring medical treatment
History of poor compliance with past anti-epileptic drug therapy
Suicide attempt in the past five years

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236886

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director:

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

Publications:

Ben-Menachem E, Axelsen M, Johanson EH, Stagge A, Smith U. Predictors of weight loss in adults with topiramate-treated epilepsy. Obes Res. 2003 Apr;11(4):556-62.

ClinicalTrials.gov Identifier:	NCT00236886 History of Changes
Other Study ID Numbers:	CR003703
Study First Received:	October 7, 2005
Last Updated:	April 26, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Epilepsy
Partial Epilepsy
Secondary Generalized Epilepsy
Primary Generalized Epilepsy

Tonic-Clonic Seizures
Topiramate
Weight Loss

Additional relevant MeSH terms:

Body Weight Changes
Epilepsy
Epilepsies, Partial
Epilepsy, Generalized
Seizures
Body Weight
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Neurologic Manifestations
Topiramate
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on February 09, 2012