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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: | NCT00236730 |
The purpose of the study is to evaluate the effectiveness and safety of topiramate as add-on therapy in patients with difficult to control partial onset seizures who are taking one or two standard anti-epileptic drugs.
Condition | Intervention | Phase |
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Epilepsies, Partial Seizures Epilepsy |
Drug: topiramate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double-Blind Parallel Comparison of Three Doses of Topiramate and Placebo in Refractory Partial Epilepsy |
Estimated Enrollment: | 180 |
Estimated Study Completion Date: | December 1990 |
Epilepsy is characterized by seizures, which are abnormal electrical discharges in the brain that temporarily disrupt normal brain function. Seizures are classified as "generalized," originating in both sides of the brain simultaneously, or "partial-onset," starting in one area of the brain. Antiepilepsy medications, such as topiramate, are selected based on seizure type. This is a double-blind, placebo-controlled study that includes a baseline phase and a treatment phase. During the baseline phase (12 weeks duration), patients receive one or two of the following standard antiepileptic drugs (AEDs): phenytoin, carbamazepine, phenobarbital, or primidone. Patients who continue to have seizures during treatment with standard AEDs proceed into the double-blind treatment phase. Patients then receive placebo or topiramate at a dosage of 100-milligrams (mg) once daily, increasing to twice daily dosing at a maximum dose of 200 mg/day, 400 mg/day, or 600 mg/day or maximum tolerated dose (depending on treatment group), through Week 16 (total duration of double-blind phase), while continuing on their standard AED regimen. Assessments of effectiveness include the percent reduction in the average monthly seizure rate, percent of patients responding to treatment (having equal to or greater than 50% reduction in seizure rate), and, the patient's and investigator's global assessments of medication at end of study. Safety assessments include the incidence of adverse events throughout the study, clinical laboratory tests (hematology, serum chemistry, urinalysis), neurologic examinations, and vital sign measurements (blood pressure, pulse, temperature) weekly during the treatment phase. The study hypothesis is that topiramate, taken as add-on therapy to treatment with AEDs, will significantly reduce seizure frequency, compared with placebo, in patients with refractory partial epilepsy and is well-tolerated.
Topiramate, 100 milligrams[mg] oral tablets. Dosage begins at 100-mg once daily and increases gradually to twice daily dosing at a maximum dose of 200, 400, or 600 mg/day, and continues through Week 16 (total duration).
Ages Eligible for Study: | 18 Years to 65 Years |
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: | CR005458 |
Study First Received: | October 7, 2005 |
Last Updated: | October 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00236730 |
Health Authority: | United States: Food and Drug Administration |
partial seizure disorder seizures partial epilepsies partial epilepsy |
topiramate brain diseases epilepsy epileptic seizures |
Epilepsies, Partial Signs and Symptoms Epilepsy Seizures |
Topiramate Neurologic Manifestations Central Nervous System Diseases Brain Diseases |
Anti-Obesity Agents Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases Protective Agents |
Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions Anticonvulsants |