An Open-Label Extension Study to Evaluate the Safety and Tolerability of RWJ 333369 as Adjunctive Therapy in Patients 16 Years and Older With Partial Onset Seizures.

Sponsor
SK Life Science, Inc.
Study ID
NCT00991757
Phase
PHASE3
Status
Completed

Conditions

  • Complex Partial Seizures
  • Epilepsies, Partial
  • Epilepsy
  • Epilepsy, Complex Partial

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • carisbamate — DRUG
    Open-Label Extension: 400 mg/day (up to a maximum of 1200mg/day) given in 2 equally divided doses for up to 1 year (or until carisbamate is available by prescription or the sponsor terminates the study).

Study Details

The purpose of this open-label extension study is to demonstrate that RWJ-333369 is safe as long-term add-on treatment of partial onset seizures.

Key Dates

Start date
Feb 28, 2007
Status verified
Jun 2013
Primary completion
Oct 31, 2010
Completion
Oct 31, 2010

Study Design

Enrollment
991 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 001
    carisbamate Open-Label Extension: 400 mg/day (up to a maximum of 1200mg/day) given in 2 equally divided doses for up to 1 year (or until carisbamate is available by prescription or the sponsor terminates the study).

Primary Outcome Measure

Worsening of seizures, including rates of status epilepticus. [ Time Frame: Up to approximately 48 months ]

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