A Phase 3 interventional study of topiramate in Epilepsy, Seizures and Epilepsies, Partial, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Completed. Per ClinicalTrials.gov, last updated 2011-06-08.
Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment
The purpose of this study is to compare the safety and effectiveness of two doses of topiramate as monotherapy in the treatment of pediatric and adult patients with newly diagnosed or recurrent epilepsy.
Topiramate is approved for treating epilepsy in combination with other epilepsy drugs, but not approved for treating epilepsy as sole treatment or in recently diagnosed epilepsy characterized by partial-onset seizures. This is a randomized, double-blind, parallel-group, multicenter study to compare the safety and effectiveness of two doses of topiramate as monotherapy in pediatric and adult patients with newly diagnosed (within 3 months) or recurrent epilepsy (partial-onset or primary generalized tonic-clonic). The study consists of 4 phases: Baseline (assessment of seizure frequency and other eligibility), Open-Treatment (all patients receive 25 milligrams[mg]/day of topiramate for 7 days), Core Double-Blind Phase (patients are randomized to receive either their assigned dose of topiramate of 50mg/day or 400mg/day, or maximum tolerated dose, and then remain, if possible, on that dose for the duration of the double-blind phase; they continue to receive the medication until they experience the first seizure or until 6 months after the last patient is enrolled), and Long-Term Extension Phase (patients continue to receive the medication at maximum tolerated dose, which may be adjusted according to individual tolerability and effectiveness, until either the patient withdraws or the sponsor terminates the study). The study hypothesis is that topiramate will be effective in the treatment of newly diagnosed or recurrent epilepsy in dose-dependent manner. Topiramate tablets (25 milligrams[mg]) daily by mouth in once-daily regimen during the 7-day Open-Treatment Phase; topiramate twice daily for total of 50mg/day or 400mg/day during the Double-Blind Phase.
1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.
This study's enrollment of 750 is above the median of 50 across 1,239 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is the lead sponsor of 465 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Time to first seizure (partial onset or generalized tonic-clonic seizure) during the core double-blind phase (excluding taper).
Mean plasma topiramate levels for the high and low topiramate dosing groups; laboratory evaluations, vital signs, visual field testing results, and adverse events during trial
No study locations are listed for this record.
The record gives a start of Jul 1999 and a completion of Sep 2003. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Topiramate
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