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Clinical Trials/NCT00175851
NCT00175851
Withdrawn
Phase 3

An Open-label, Multicenter, Follow-up Trial to Evaluate the Long-term Safety and Efficacy of Seletracetam Used as Adjunctive Treatment Using a Flexible Dosing Scheme of 4 to 80 mg b.i.d. in Subjects Aged 16 Years or Older Suffering From Epilepsy

UCB Pharma0 sitesStarted: May 2008Last updated:
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ConditionsEpilepsy
DrugsSeletracetam (ucb 44212)

Overview

Phase
Phase 3
Status
Withdrawn
Sponsor
UCB Pharma
Primary Endpoint
Safety profile of seletracetam
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Masking
None

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Safety profile of seletracetam

Secondary Outcomes

  • Reduction in seizure frequency

Investigators

Sponsor
UCB Pharma
Sponsor Class
Industry

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