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

Johnson & Johnson (J&J)

Status and phase

Completed

Phase 3

Conditions

Epilepsy, Generalized

Seizures

Epilepsy

Epilepsies, Partial

Treatments

Drug: topiramate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00236886

CR003703

Details and patient eligibility

About

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

Full 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.

Enrollment

49 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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