Open Label Trial to Study the Long-term Safety and Efficacy of Seletracetam for the Treatment of Epilepsy

Epilepsy Clinical Trial

Official title:

An Open-label, Multicenter, Follow-up Trial to Evaluate the Long-term Safety and Efficacy of Seletracetam Used as Adjunctive Treatment Using a Flexible Dosing Scheme of 4 to 80 mg b.i.d. in Subjects Aged 16 Years or Older Suffering From Epilepsy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00175851
• Other study ID #: N01197
• Secondary ID: Not yet availabl
• Status: Withdrawn
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: May 25, 2012
• Start date: May 2008

Study information

• Verified date: May 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 epilepsy patients who have participated in a previous seletracetam study

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• A signed and dated IRB/IEC approved written informed consent form

• Male/female age 18 years (16 years where permitted) to 65 years

• Minimum body weight of 40 kg

• Patients having participated in a previous seletracetam study

• Female patients without childbearing potential or using a medically accepted non-hormonal contraceptive method are eligible.

Exclusion Criteria:

• Ongoing psychiatric disease other than mild controlled disorders

• Subject with clinically significant abnormalities in laboratory tests or ECG

• Poor compliance with visit schedule or medication intake in a previous seletracetam study

• Subject taking part in another clinical/pharmacological study, with the exception of seletracetam studies, in the 30 days preceding enrollment

Study Design

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

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