Status:
WITHDRAWN
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.
Lead Sponsor:
UCB Pharma
Conditions:
Epilepsy
Eligibility:
All Genders
16-65 years
Phase:
PHASE3
Brief Summary
This is a safety and efficacy study of add on therapy with seletracetam in patients experiencing refractory epilepsy.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00175864
Start Date
February 1 2006
Last Update
March 20 2012
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