An Open-Label Extension Study of the Effectiveness and Safety of the Investigational Compound RWJ-333369 in Patients With Epilepsy

Epilepsy Clinical Trial

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])

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00210522
• Other study ID #: CR002191
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: January 15, 2013
• Start date: May 2005
• Est. completion date: June 2010

Study information

• Verified date: January 2013
• Source: SK Life Science
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 421
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SK Life Science

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events		Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor	No
Primary	Clinical laboratory test values		Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor	No
Primary	12-lead ECG recordings		Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor	No
Primary	Vital sign measurements		Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor	No