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Clinical Trial: Open Label Study (Everyone Who Participates Receives Drug) to Further Determine How Safe and Effective Oral Treatment of Seletracetam is in Patients with Refractory Epilepsy.
This study is not yet open for patient recruitment.
Verified by UCB Pharma September 2005
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Epilepsy | Drug: Seletracetam (ucb 44212) | Phase III |
MedlinePlus related topics: Epilepsy
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title: Open Label, Multicenter Study of the Safety and Efficacy of Oral Treatment with Immediate Release Seletracetam (Ucb 44212) at Individualized Doses Up to a Maximum of 160mg/Day in Refractory Epileptic Patients.
Secondary Outcomes: Reduction in seizure frequency
Expected Total Enrollment: 500
Eligibility
Inclusion Criteria:
• An IRB/IEC approved written informed consent form signed and dated Male/Female patients age 18 (or 16 years where permitted by law) to 65.
• Minimum body weight of 40 kg. • Patients with a confirmed diagnosis of refractory epilepsy of ≥ 6 months. • Patients must be receiving 1 – 3 concomitant AEDs. • Female patients without childbearing potentials (2 years post-menopausal or surgical sterilization) are eligible. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method.
Exclusion Criteria:
• Seizures occurring in clusters (seizures occurring either too frequently or indistinctly separated to be reliably counted).
• Status epilepticus within 3 months of Visit 1. • History of non-epileptic seizures. • Patients on vigabatrin. • Patients on felbamate, unless treatment has been continuous for ≥ 18 months. • Use of benzodiazepines (for any indication) taken at a higher frequency than an average of once a week, unless counted as one of the concomitant AEDs.
• Ongoing psychiatric disease other than mild controlled disorders. • Patients with a clinically significant organ dysfunction. • Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients.
• Pregnant or lactating women. Any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control.
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: NCT00175864
Health Authority: United States: Food and Drug Administration; Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-09-20

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