Epilepsy Clinical Trial
Official 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.
The purpose of this study is to assess a possible predictor for weight loss seen in epilepsy patients treated with topiramate.
Status | Completed |
Enrollment | 49 |
Est. completion date | June 2000 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Ben-Menachem E, Axelsen M, Johanson EH, Stagge A, Smith U. Predictors of weight loss in adults with topiramate-treated epilepsy. Obes Res. 2003 Apr;11(4):556-62. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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