A Study of the Efficacy and Safety of RWJ-333369 as add-on Therapy in the Treatment of Partial Onset Seizures.
Epilepsy Phase III Trial
1 other identifier
interventional
563
0 countries
N/A
Brief Summary
The purpose of this study is to demonstrate that RWJ-333369 is safe and effective as add-on treatment of partial onset seizures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2006
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 9, 2007
CompletedFirst Posted
Study publicly available on registry
February 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedJune 18, 2012
June 1, 2012
11 months
February 9, 2007
June 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome is the change in seizure frequency of all simple partial motor, complex partial, or secondarily generalized seizures from the pretreatment baseline phase compared with the double-blind treatment phase.
Secondary Outcomes (1)
The key secondary outcome is the change in the Seizure Severity Questionnaire score.
Interventions
Eligibility Criteria
You may qualify if:
- Male or Female, 16 year or older
- Clinical diagnosis of focal epilepsy for at least 1 year
- History of poor response to at least 1 anti-epileptic drug in the past
- Current treatment with 1 or 2 anti-epileptic drugs
- Should have at least 3 seizures per month
You may not qualify if:
- Generalized epilepsy
- Cannot count your seizures
- Unstable medical disease, such as a recent heart attack or uncontrolled diabetes
- Major psychiatric illness
- Recent drug or alcohol abuse
- Unable to swallow pills
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Lu C, Zheng J, Cao Y, Bresnahan R, Martin-McGill KJ. Carisbamate add-on therapy for drug-resistant focal epilepsy. Cochrane Database Syst Rev. 2021 Dec 6;12(12):CD012121. doi: 10.1002/14651858.CD012121.pub2.
PMID: 34870321DERIVEDSperling MR, Greenspan A, Cramer JA, Kwan P, Kalviainen R, Halford JJ, Schmitt J, Yuen E, Cook T, Haas M, Novak G. Carisbamate as adjunctive treatment of partial onset seizures in adults in two randomized, placebo-controlled trials. Epilepsia. 2010 Mar;51(3):333-43. doi: 10.1111/j.1528-1167.2009.02318.x. Epub 2009 Oct 27.
PMID: 19863578DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2007
First Posted
February 12, 2007
Study Start
November 1, 2006
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
June 18, 2012
Record last verified: 2012-06