Status:
COMPLETED
Prospective Pilot Study on Metabolism and Weight Changes in Topiramate-Treated Epilepsy Patients
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Epilepsy
Epilepsies, Partial
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess a possible predictor for weight loss seen in epilepsy patients treated with topiramate.
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2000
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00236886
Start Date
May 1 1998
End Date
June 1 2000
Last Update
April 28 2010
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