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

Tracking Information

First Received Date ^ICMJE

October 7, 2005

Last Updated Date

June 18, 2009

Start Date ^ICMJE

May 1998

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00236886 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief Summary

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

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Epilepsy
Epilepsies, Partial
Epilepsy, Generalized
Seizures

Intervention ^ICMJE

Drug: topiramate

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2000

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00236886

Responsible Party

Study ID Numbers ^ICMJE

CR003703

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

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

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

Information Provided By

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

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP