Prospective Pilot Study on Metabolism a… | Clinical Trial

Key information

Conditions

Epilepsy Body Weight Body Weight Changes Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy, Generalized Epilepsy, Idiopathic Generalized Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms Weight Loss

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topiramate

Drug

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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.

Important dates

Study start: 1998
Study completion: 2000
First posted: Oct 12, 2005
Registry last updated: Apr 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed