Prospective Pilot Study on Metabolism and Weight Changes in Topiramate-Treated Epilepsy Patients (NCT00236886) | Clinical Trial Compass
CompletedPhase 3
Prospective Pilot Study on Metabolism and Weight Changes in Topiramate-Treated Epilepsy Patients
49 participantsStarted 1998-05
Plain-language summary
The purpose of this study is to assess a possible predictor for weight loss seen in epilepsy patients treated with topiramate.
Who can participate
Age range16 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
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
Trial details
NCT IDNCT00236886
SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.