Clinical trial NCT00210522: An Open-Label Extension Study of the Effectiveness and Safety of the Investigational Compound RWJ-333369 in Patients With Epilepsy
Official title: 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])
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy
Epilepsies, Partial
Keywords: RWJ-333369
Anticonvulsants
Epilepsy
Refractory partial epilepsy
Seizure disorder
Antiepileptic drugs
Lead sponsor: SK Life Science, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 421
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adverse events
timeFrame: Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor
measure: Clinical laboratory test values
timeFrame: Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor
measure: 12-lead ECG recordings
timeFrame: Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor
measure: Vital sign measurements
timeFrame: Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Faught E, Holmes GL, Rosenfeld WE, Novak G, Neto W, Greenspan A, Schmitt J, Yuen E, Reines S, Haas M. Randomized, controlled, dose-ranging trial of carisbamate for partial-onset seizures. Neurology. 2008 Nov 11;71(20):1586-93. doi: 10.1212/01.wnl.0000334751.89859.7f.