Carisbamate Retention Study (CaReS): Comparative Study on the Long Term Effectiveness, Safety and Tolerability of Carisbamate Compared to Two Other Frequently Prescribed Anti-epileptic Drugs (AEDs) in Patients With Epilepsy.

Sponsor
SK Life Science, Inc.
Study ID
NCT00563459
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • carisbamate — DRUG
    400-1200 mg/day for 12 months
  • topiramate — DRUG
    200-400mg/day for 12 months
  • levetiracetam — DRUG
    1000-3000mg/day for 12 months

Study Details

The purpose of this research study is to compare the long term effectiveness, safety and tolerability of carisbamate compared to two other frequently prescribed anti-epileptic drugs (AEDs) in patients with epilepsy.

Key Dates

Start date
Nov 30, 2007
Status verified
Jan 2013
Primary completion
Apr 30, 2010
Completion
Apr 30, 2010

Study Design

Enrollment
89 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 001
    carisbamate 400-1200 mg/day for 12 months
  • Active Comparator: 002
    topiramate 200-400mg/day for 12 months
  • Active Comparator: 003
    levetiracetam 1000-3000mg/day for 12 months

Primary Outcome Measure

The primary efficacy endpoint is time from the first intake of study medication to discontinuation (all causes) of study medication during the 6 month core double-blind phase. [ Time Frame: A six month period ]

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