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Safety and Efficacy of 333369 in the Treatment of Partial Epilepsy

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SK Life Science

Status and phase

Completed
Phase 2

Conditions

Refractory Epilepsy

Treatments

Drug: RWJ-333369

Study type

Interventional

Funder types

Industry

Identifiers

NCT00228969
333369-EPY-2003

Details and patient eligibility

About

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of 4 daily doses of RWJ-333369 as adjunctive treatment of refractory partial epilepsy in subjects who are between 18 and 70 years of age, inclusive

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age 18-70 years old,
  2. Diagnosis of epilepsy for at least 1 year,
  3. Presenting, on average, at least 3 partial onset seizures per month,
  4. Currently treated with a stable dose (i.e., for at least 4 weeks) of no more than 3 anti-epileptic drugs (AEDs),

Exclusion criteria

  1. Have experienced status epilepticus in the past 3 months,
  2. Have any serious diseases,
  3. History of major psychiatric disorders within the past 2 years.
  4. Have received an experimental drug/device within the past 30 days
  5. Are pregnant or breastfeeding.

Trial contacts and locations

61

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Data sourced from clinicaltrials.gov

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