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Open Label Trial to Study the Long-term Safety and Efficacy of Seletracetam for the Treatment of Epilepsy

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UCB

Status and phase

Withdrawn
Phase 3

Conditions

Epilepsy

Treatments

Drug: Seletracetam (ucb 44212)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00175851
Not yet available
N01197

Details and patient eligibility

About

This is a safety and efficacy study of add-on therapy with seletracetam in epilepsy patients who have participated in a previous seletracetam study

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • A signed and dated IRB/IEC approved written informed consent form
  • Male/female age 18 years (16 years where permitted) to 65 years
  • Minimum body weight of 40 kg
  • Patients having participated in a previous seletracetam study
  • Female patients without childbearing potential or using a medically accepted non-hormonal contraceptive method are eligible.

Exclusion criteria

  • Ongoing psychiatric disease other than mild controlled disorders
  • Subject with clinically significant abnormalities in laboratory tests or ECG
  • Poor compliance with visit schedule or medication intake in a previous seletracetam study
  • Subject taking part in another clinical/pharmacological study, with the exception of seletracetam studies, in the 30 days preceding enrollment

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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