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

April 26, 2010 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1998

Study Completion (Actual)

June 1, 2000

Study Registration Dates

First Submitted

October 7, 2005

First Submitted That Met QC Criteria

October 11, 2005

First Posted (Estimate)

October 12, 2005

Study Record Updates

Last Update Posted (Estimate)

April 28, 2010

Last Update Submitted That Met QC Criteria

April 26, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR003703

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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