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This study has been withdrawn prior to enrollment.
Information provided by:
First received: September 9, 2005
Last updated: March 19, 2012
Last verified: March 2012
This is a safety and efficacy study of add on therapy with seletracetam in patients experiencing refractory epilepsy.
Drug: Seletracetam (ucb 44212)
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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.
Primary Outcome Measures:
- Safety profile of seletracetam
Secondary Outcome Measures:
- Reduction in seizure frequency
| Study Start Date:
|Ages Eligible for Study:
||16 Years to 65 Years
|Genders Eligible for Study:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00175864
||Barbara Bennett, PhD
No publications provided
History of Changes
|Other Study ID Numbers:
||N01212, Not yet available
|Study First Received:
||September 9, 2005
||March 19, 2012
||United States: Food and Drug Administration
Canada: Health Canada
Keywords provided by UCB, Inc.:
Partial Onset, Primary Generalized Seizures, Seletracetam
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Central Nervous System Diseases
Nervous System Diseases