Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) With Partial Onset Seizures

• ClinicalTrials.gov Identifier: NCT00152451
• Recruitment Status: Completed
• First Posted: September 9, 2005
• Last Update Posted: February 10, 2017
• Sponsor: UCB Pharma
• Information provided by: UCB Pharma

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 (Clinical Trial)
• Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: An Open-label, Exploratory, Multicenter, Dose-escalation Study Examining the Efficacy, Safety and Tolerability of Ucb 44212 Used at Doses of 10 mg, 20 mg, 40 mg and 80 mg b.i.d. (Total Daily Dose of 20 to 160 mg) in Adult Subjects (18-65 Years) With Refractory Epilepsy Suffering From Partial Onset Seizures (Whether or Not Secondarily Generalized) and Treated With 1, 2 or 3 Approved Antiepileptic Drugs
• Study Start Date: May 2005
• Actual Primary Completion Date: January 2007
• Actual Study Completion Date: January 2007

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Safety and tolerability

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All

Criteria

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).
• Female subjects without childbearing potential; Female subjects with childbearing potential are eligible if they use a medically accepted non-hormonal 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.
• Subjects currently taking levetiracetam (LEV).
• 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

United States, Arkansas

Little Rock, Arkansas, United States, 72205

United States, California

San Francisco, California, United States, 94115

Stanford, California, United States, 94302

United States, North Carolina

Durham, North Carolina, United States, 27710

United States, Ohio

Columbus, Ohio, United States, 43210

United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

United States, Tennessee

Nashville, Tennessee, United States, 37212

United States, Virginia

Charlottesville, Virginia, United States, 22908

Sponsors and Collaborators

UCB Pharma

Investigators

• Study Director: Barbara Bennett, PhD; UCB Pharma

More Information

• ClinicalTrials.gov Identifier: NCT00152451
• Other Study ID Numbers: N01191
• First Posted: September 9, 2005
• Last Update Posted: February 10, 2017
• Last Verified: February 2017

Keywords provided by UCB Pharma:

Epilepsy: partial onset seizures, seletracetam

Additional relevant MeSH terms:

Epilepsy; Seizures; Epilepsies, Partial; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations