Open Label Trial to Study the Long-term Safety and Efficacy of Seletracetam for the Treatment of Epilepsy
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
2 other identifiers
interventional
N/A
0 countries
N/A
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
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedMay 28, 2012
May 1, 2012
September 9, 2005
May 25, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety profile of seletracetam
Secondary Outcomes (1)
Reduction in seizure frequency
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Barbara Bennett, PhD
UCB Pharma
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 15, 2005
Study Start
May 1, 2008
Last Updated
May 28, 2012
Record last verified: 2012-05