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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This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00175851
First received: September 9, 2005
Last updated: May 25, 2012
Last verified: May 2012
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
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
U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Safety profile of seletracetam

Secondary Outcome Measures:
  • Reduction in seizure frequency

Enrollment: 0
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, Inc.
Investigators
Study Director: Barbara Bennett, PhD UCB, Inc.
  More Information

No publications provided

Responsible Party: Study Director, UCB
ClinicalTrials.gov Identifier: NCT00175851     History of Changes
Other Study ID Numbers: N01197, Not yet available
Study First Received: September 9, 2005
Last Updated: May 25, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by UCB, Inc.:
Partial onset, primary generalized seizures, seletracetam

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013