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

This study has been withdrawn prior to recruitment.

First Received: September 9, 2005 Last Updated: February 22, 2008 History of Changes

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00175851

Purpose

This is a safety and efficacy study of add-on therapy with seletracetam in epilepsy patients who have participated in a previous seletracetam study

Condition	Intervention	Phase
Epilepsy	Drug: Seletracetam (ucb 44212)	Phase III

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
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

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Seletracetam

Further study details as provided by UCB:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	1500
Study Start Date:	May 2008

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175851

Sponsors and Collaborators

UCB

Investigators

Study Director:

Barbara Bennett, PhD

UCB

More Information

No publications provided

Responsible Party:	UCB ( Study Director )
Study ID Numbers:	N01197, Not yet available
Study First Received:	September 9, 2005
Last Updated:	February 22, 2008
ClinicalTrials.gov Identifier:	NCT00175851 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by UCB:

Partial onset, primary generalized seizures, seletracetam

Study placed in the following topic categories:

Epilepsy
Seizures
Central Nervous System Diseases
Brain Diseases

Additional relevant MeSH terms:

Epilepsy
Nervous System Diseases
Central Nervous System Diseases
Brain Diseases

ClinicalTrials.gov processed this record on September 02, 2009