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

NCT00210522 | Completed Phase 2

• 1 other identifier: CR002191
• Study Type: interventional
• Target: 421
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Epilepsy; Epilepsies, Partial

Keywords

RWJ-333369; Anticonvulsants; Epilepsy; Refractory partial epilepsy; Seizure disorder; Antiepileptic drugs

Outcome Measures

Primary Outcomes (4)

• Adverse events

  Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor

• Clinical laboratory test values

  Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor

• 12-lead ECG recordings

  Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor

• Vital sign measurements

  Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor

Study Arms (1)

001

EXPERIMENTAL

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.

Drug: RWJ 333369

Interventions

RWJ 333369 DRUG

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.

001

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SK Life Science, Inc.: lead

Related Publications (1)

• 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.

  PMID: 19001248 DERIVED

MeSH Terms

Conditions

Epilepsy; Epilepsies, Partial

Interventions

S-2-O-carbamoyl-1-o-chlorophenyl-ethanol

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: May 1, 2005
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: January 24, 2013

Record last verified: 2013-01