Not Signed In -
Epilepsy |
Seizure Disorders |
Clinical Trial: Open Label Trial to Study the Long-Term Safety and Efficacy of Seletracetam for the Treatment of Epilepsy
This study is not yet open for patient recruitment.
Verified by UCB Pharma September 2005
|
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Epilepsy | Drug: Seletracetam (ucb 44212) | Phase III |
MedlinePlus related topics: Epilepsy
Study Type: Interventional
Study Design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title: 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
Secondary Outcomes: Reduction in seizure frequency
Expected Total Enrollment: 1500
Eligibility
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 • Minimim 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
Location and Contact Information
Barbara Bennett, PhD, Study Director, UCB Pharma, Inc.
More Information
Last Updated: September 14, 2005
Record first received: September 9, 2005
ClinicalTrials.gov Identifier: NCT00175851
Health Authority: United States: Food and Drug Administration; Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-09-20
Resources
- (National Women's Health Information Center, OWH, HHS)
- A Pacemaker for the Brain (Cleveland Clinic)
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