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Epilepsy Extension Trial: Study to Evaluate the Safety and Tolerability of RWJ 333369 as Adjunctive Therapy in Subjects With Partial Onset Seizures

2014-07-23 21:12:33 | BioPortfolio

Summary

The purpose of this study is to demonstrate that RWJ-333369 is safe as long-term add-on treatment of partial onset seizures.

Description

333369EPY3004 is the open-label extension study that follows 333369EPY3001 and 333369EPY3002, the double blind studies. In an open label study such as 333369EPY3004, both the physician and the patient know the name of the assigned study medication. In a double blind study such as 333369EPY3001 and 333369EPY3002, neither the physician nor the patient knows the name of the assigned study medication. Patients who complete the double-blind treatment phase of studies 333369EPY3001 and 333369EPY3002 will be eligible to enter the open-label extension study during which patients will transition through a blinded period to open-label carisbamate. There will be a blinded transition during which patients will take blinded study medication; after this, patients will then take unblinded, open-label study medication. Safety assessments include the monitoring of the frequency, severity, and timing of adverse events, clinical laboratory test results, 12-lead electrocardiogram (ECG) recordings, vital signs measurements, physical and neurologic examinations, the Physician Withdrawal Checklist for symptoms of withdrawal for those patients who taper and/or discontinue study drug, and pregnancy tests for females of childbearing potential. Seizure counts will be obtained at every visit. A Quality of Life in Epilepsy questionnaire will be administered during the study. There is no statistical testing hypothesis for this study.

Detailed Description update,5 Oct 2009. The Sponsor in conjunction with the DSMB agreed to amend the protocol to withdraw subjects who develop signs of a drug hypersensitivity reaction. 200 mg per day RWJ-333369, 400 mg per day RWJ-333369, or 600 mg per day RWJ-333369, given twice daily with or without food approximately 12 hours apart; study drug should be swallowed whole and not be chewed, divided, crushed, or dissolved.

Study Design

N/A

Conditions

Epilepsy

Intervention

carisbamate 200mg, carisbamate 100mg, carisbamate 400mg

Status

Active, not recruiting

Source

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:12:33-0400

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