An open label study to evaluate the efficacy, safety and tolerability of RWJ333369 as adjunctive therapy in subjects with partial onset seizure

• Conditions: Partial Onset Epilepsy Seizures

• Registration Number: EUCTR2007-001801-99-HU
• Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 510

Inclusion Criteria

For the double blind trial 3002:
1. Male or female aged 16 years or older, inclusive. 2. Weight of at least 40 kg. 3. Established diagnosis of partial epilepsy for at least 1 year, using ILAE criteria. 4. History of inadequate response to at least 1 AED. 5. Current treatment with at least 1 and no more than 2 AED's. 6. Have had at least 3 simple partial motor, complex partial, or secondarily generalized seizures per month, and no seizure-free interval for more than 3 weeks. 6. Post-menopausal females, or those using acceptable method of birth control.
Inclusion criteria for study 3004:
subject must complete the 12-week double-blind treatment phase of study 333369-EPY-3002
subject must have signed a separate informed consent form for open-label extension study (333369-EPY-3004)
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of status epilepticus within 6 months before study entry. 2. Generalized epileptic syndrome or having only absence, atonic/tonic, or simple partial sensory or other simple partial type seizures. 3. Lennox-Gastaut Syndrome 4. Current serious or medically unstable systemic diseases. 5. Current major depression, or history of suicide within last 2 years. 6. History of drug or alcohol abuse. 7. Positive for hepatitis B or C, or HIV/AIDS. 8. History of drug-induced liver injury, or diagnosis of any form of chronic liver disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this open label study is to determine the long-term safety and tolerability of RWJ-333369 as adjunctive treatment of partial onset seizures. Safety evaluation will include worsening of seizures, including rates of status epilepticus.;Secondary Objective: The secondary objective of this study to determine health-related status as measured by the Quality of Life in Epilepsy-31 problems (QOLIE-31-P) outcomes scale.;Primary end point(s): The primary objective of this study is to determine the long-term safety and tolerability of RWJ-333369 as adjunctive treatment of partial onset seizure. Safety evaluation will include worsening of seizures, including rates of status epilepticus.<br>Subject diaries will be the source of all seizure data.