Epilepsy Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of RWJ 333369 as Adjunctive Therapy in Subjects With Partial Onset Seizures Followed by an Open-Label Extension Study: Open-Label Extension Period
Verified date | June 2013 |
Source | SK Life Science |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this open-label extension study is to demonstrate that RWJ-333369 is safe as long-term add-on treatment of partial onset seizures.
Status | Completed |
Enrollment | 991 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - In order to enter the open label extension, the patient must have completed either Study 333369EPY3001 or Study 333369EPY3002. Exclusion Criteria: - Generalized epilepsy - Currently experiencing seizures that cannot be counted accurately - Unstable medical disease, such as a recent heart attack or uncontrolled diabetes - Major psychiatric illness - Recent drug or alcohol abuse - Unable to swallow pills |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
SK Life Science |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Worsening of seizures, including rates of status epilepticus. | Up to approximately 48 months | No | |
Secondary | Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) | month 6 | No |
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