A Study of the Efficacy and Safety of RWJ-333369 as add-on Therapy in the Treatment of Partial Onset Seizures.
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.
1 other identifier
interventional
566
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
January 19, 2007
CompletedFirst Posted
Study publicly available on registry
January 22, 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 20, 2012
June 1, 2012
11 months
January 19, 2007
June 19, 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
January 19, 2007
First Posted
January 22, 2007
Study Start
November 1, 2006
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
June 20, 2012
Record last verified: 2012-06