An Open-Label Extension Study of the Effectiveness and Safety of the Investigational Compound RWJ-333369 in Patients With Epilepsy
Condition: Epilepsy; Epilepsies, Partial
MeSH terms: Epilepsy; Epilepsies, Partial
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): RWJ 333369
Intervention type(s): Drug
Intervention description(s): 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.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RWJ-333369; Anticonvulsants; Epilepsy; Refractory partial epilepsy; Seizure disorder; Antiepileptic drugs