- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00210522
An Open-Label Extension Study of the Effectiveness and Safety of the Investigational Compound RWJ-333369 in Patients With Epilepsy
January 15, 2013 updated by: SK Life Science, Inc.
A Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of RWJ-333369 as Adjunctive Therapy in Subjects With Refractory Partial Seizures (Protocol 333369-EPY-2003 [Double-blind] and Protocol 333369-EPY-2006 [Open-label Extension])
The purpose of this study is to evaluate the effectiveness and safety of the novel compound RWJ-333369 in reducing the frequency of seizures in patients with epilepsy.
Study Overview
Detailed Description
333369EPY2006 is the open-label extension study that follows the double-blind study 333369EPY2003.
In an open label study such as 333369EPY2006, both the physician and the patient know the name of the assigned study medication.
In a double blind study such as 333369EPY2003, neither the physician nor the patient knows the name of the assigned study medication.
Patients who complete the double-blind treatment phase of study 333369EPY2003 will be eligible to enter the open-label extension study during which patients will transition through a blinded period to an open-label period with carisbamate (also referred to as RWJ-333369).
RWJ-333369 is a new chemical compound with anticonvulsant activity that is currently under investigation as a treatment for epilepsy.
Patients electing to enter the open-label extension phase will be supplied with both open-label carisbamate (RWJ-333369) and blinded study medication for the transition phase.
During this transition phase (approximately 3 weeks in length), the patient's dose of double-blind study drug will be gradually reduced and stopped and treatment with open-label RWJ-333369 will be started.
Throughout the remainder of the open label extension phase, investigators will be allowed to make further adjustments of the dosage and schedule of carisbamate, including independent adjustment of the morning and evening doses, but a dosage of 1,200 mg/day may not be exceeded and increases in dosage must be in increments of no more than 200 mg/day.
After 12 months of participation in the open-label extension study, patients who, in the judgment of the investigator, continue to benefit from treatment with RWJ-333369 may continue to receive the drug with follow up clinic visits every 3 months until RWJ 333369 is available by prescription or the program is terminated by the sponsor.
RWJ-333369 (100, 300, 800, or 1,600 milligrams per day) administered orally in 2 equally divided doses for up to 16 weeks of double-blind treatment followed by the option to continue RWJ-333369 treatment in an open-label study for at least 1 year, then until drug is available or production ceases.
Study Type
Interventional
Enrollment (Actual)
421
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must complete Visit 8 (Day 112) of the double-blind treatment phase of Study EPY-2003 to be eligible for entry into the open-label treatment phase of Study EPY-2006.
Exclusion Criteria:
- Patients who have seizures that cannot be quantitated accurately
- Patients with a history of nonepileptic seizures, serious systemic disease, progressive neurologic disorder, a major psychiatric disorder, status epilepticus in the past 3 months, vagal nerve stimulation discontinuation within the past 3 months
- Patients with a history of drug or alcohol abuse within the past 2 years
- Patients currently taking felbamate, vigabatrin, or tricyclic antidepressants
- and patients who are pregnant or nursing.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 001
RWJ 333369 Open-Label Extension: One 200 mg to 600mg tablet taken twice daily (up to a maximum of 1200mg/day) up to 1 year or the time that RWJ-333369 is available by prescription or the study is terminated by Sponsor.
|
Open-Label Extension: One 200 mg to 600mg tablet taken twice daily (up to a maximum of 1200mg/day) up to 1 year or the time that RWJ-333369 is available by prescription or the study is terminated by Sponsor.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events
Time Frame: Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor
|
Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor
|
Clinical laboratory test values
Time Frame: Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor
|
Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor
|
12-lead ECG recordings
Time Frame: Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor
|
Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor
|
Vital sign measurements
Time Frame: Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor
|
Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
January 24, 2013
Last Update Submitted That Met QC Criteria
January 15, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR002191
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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