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

Purpose

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

Condition	Intervention	Phase
Epilepsy, Partial	Drug: Seletracetam (ucb 44212)	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Seizures

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	30
Study Start Date:	May 2005
Study Completion Date:	January 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152451

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, Inc.

Investigators

Study Director:

Barbara Bennett, PhD

UCB, Inc.

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00152451 History of Changes
Other Study ID Numbers:	N01191
Study First Received:	September 7, 2005
Last Updated:	September 30, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by UCB, Inc.:

Epilepsy: partial onset seizures, seletracetam

Additional relevant MeSH terms:

Epilepsy
Epilepsies, Partial
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Neurologic Manifestations
Signs and Symptoms
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013