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Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00236886 |
The purpose of this study is to assess a possible predictor for weight loss seen in epilepsy patients treated with topiramate.
Condition | Intervention | Phase |
---|---|---|
Seizures Epilepsies, Partial Epilepsy Epilepsy, Generalized |
Drug: topiramate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 50 |
Study Start Date: | May 1998 |
Estimated Study Completion Date: | June 2000 |
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.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR003703 |
Study First Received: | October 7, 2005 |
Last Updated: | May 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00236886 History of Changes |
Health Authority: | United States: Institutional Review Board |
Primary Generalized Epilepsy Weight Loss Tonic-Clonic Seizures Epilepsy |
Partial Epilepsy Secondary Generalized Epilepsy Topiramate |
Epilepsies, Partial Seizures Central Nervous System Diseases Brain Diseases Neuroprotective Agents Body Weight Anti-Obesity Agents Signs and Symptoms |
Epilepsy Weight Loss Neoplasm Metastasis Body Weight Changes Neurologic Manifestations Topiramate Epilepsy, Generalized Anticonvulsants |
Epilepsies, Partial Physiological Effects of Drugs Seizures Nervous System Diseases Central Nervous System Diseases Brain Diseases Protective Agents Neuroprotective Agents Pharmacologic Actions |
Anti-Obesity Agents Signs and Symptoms Epilepsy Therapeutic Uses Neurologic Manifestations Topiramate Epilepsy, Generalized Central Nervous System Agents Anticonvulsants |