Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam

• Sponsor: UCB Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00152503
• Collaborator: (none)
• Enrollment: 60
• Locations: 17
• Duration (Months): 17
• Patients Per Site: 3.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This trial will evaluate the efficacy and safety of ucb 44212 as add-on therapy in subjects with focal epilepsy.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy, Partial	Drug: Seletracetam (ucb 44212)	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: An Open Label, Exploratory, Dose-Escalation, Multicenter Study Examining the Safety, Tolerability and Efficacy of Ucb 44212 (Seletracetam) Used at Doses of 10, 20, 40, and 80 mg b.i.d. (Total Daily Doses of 20 - 160 mg) Administration (Oral Capsules) in Adult Subjects (18 - 65 Years) With Refractory Epilepsy Suffering From Partial Onset Seizures Who Are Currently Receiving Levetiracetam (LEV) But Still Experiencing Seizures
• Study Start Date: Aug 1, 2005
• Actual Primary Completion Date: Jan 1, 2007
• Actual Study Completion Date: Jan 1, 2007

Outcome Measures

Primary Outcome Measures

1. Reduction in seizure frequency over 11-week treatment period []

Secondary Outcome Measures

1. Safety and Tolerability []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• Males/Females from 18 to 65 years of age (minimum body weight of 40 kg)

• Subjects with a confirmed diagnosis of epilepsy suffering from partial onset seizures whether or not secondarily generalized.

• Subjects who have been treated for epilepsy for ≥6 months and are currently uncontrolled while being treated with 1-3 concomitant AED(s), inclusive of LEV.

• Female subjects without childbearing potential or those who are using an acceptable contraceptive method

Exclusion Criteria:

• Seizures occurring in clusters. Status epilepticus within 6 months of Visit 1. History of non-epileptic seizures

• Subjects on vigabatrin

• Subjects on felbamate, unless treatment has been continuous for >2 years

• Ongoing psychiatric disease other than mild controlled disorders.

• Subjects with clinically significant organ dysfunction

• Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients

• Pregnant or lactating women.

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Phoenix	Arizona	United States
2		Little Rock	Arkansas	United States
3		St Petersburg	Florida	United States
4		Springfield	Illinois	United States
5		Witchita	Kansas	United States
6		Detroit	Michigan	United States
7		Chesterfield	Missouri	United States
8		Cincinnati	Ohio	United States
9		Columbus	Ohio	United States
10		Philadelphia	Pennsylvania	United States
11		Nashville	Tennessee	United States
12		Dallas	Texas	United States
13		Charlottesville	Virginia	United States
14		Milwaukee	Wisconsin	United States
15		Edmonton	Alberta	Canada
16		Calgary		Canada
17		Montreal		Canada

Sponsors and Collaborators

• UCB Pharma

Investigators

• Study Director: Barbara Bennett, PhD, UCB Pharma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00152503
• Other Study ID Numbers: N01192
• First Posted: Sep 9, 2005
• Last Update Posted: Oct 1, 2008
• Last Verified: Sep 1, 2008

• Keywords provided by , ,: Epilepsy, Partial Onset Seizures, Seletracetam
• Additional relevant MeSH terms: Epilepsy; Seizures; Epilepsies, Partial

Study Results

No Results Posted as of Oct 1, 2008