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.

Epilepsy Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00175864
• Other study ID #: N01212
• Secondary ID: Not yet availabl
• Status: Withdrawn
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: March 19, 2012
• Start date: February 2006

Study information

• Verified date: March 2012
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Gender: Both
• Age group: 16 Years to 65 Years

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Seletracetam (ucb 44212)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety profile of seletracetam
Secondary	Reduction in seizure frequency