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.

NCT ID: NCT00175864

Last Updated: 2012-03-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28

Brief Summary

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

Conditions

Epilepsy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Seletracetam (ucb 44212)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: lead

Principal Investigators

Barbara Bennett, PhD

Role: STUDY_DIRECTOR

UCB Pharma

Other Identifiers

Not yet available

Identifier Type: -

Identifier Source: secondary_id

N01212

Identifier Type: -

Identifier Source: org_study_id