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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. - Article


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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

Sponsored by: UCB Pharma
Information provided by: UCB Pharma
ClinicalTrials.gov Identifier: NCT00175864

Purpose

This is a safety and efficacy study of add on therapy with seletracetam in patients experiencing refractory epilepsy.
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.

Further Study Details: 
Primary Outcomes: Safety profile of seletracetam
Secondary Outcomes: Reduction in seizure frequency
Expected Total Enrollment:  500

Eligibility

Ages Eligible for Study:  16 Years   -   65 Years,  Genders Eligible for Study:  Both
Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00175864

UCB- Clinical Trial Call Center      + 1 877 822 9493 

Study chairs or principal investigators

Barbara Bennett, PhD,  Study Director,  UCB Pharma, Inc.   

More Information

Study ID Numbers:  N01212; Not yet available
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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