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This study has been withdrawn prior to enrollment.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 Pharma
ClinicalTrials.gov Identifier:
NCT00175851
First received: September 9, 2005
Last updated: May 25, 2012
Last verified: May 2012
  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:


Further study details as provided by UCB Pharma:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: Barbara Bennett, PhD UCB Pharma
  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 Pharma:
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 October 02, 2014