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

• Status: Completed
• Trial end date: 2000-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Topiramate

Criteria

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