This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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This study has been withdrawn prior to enrollment.
Information provided by:
UCB Pharma Identifier:
First received: September 9, 2005
Last updated: May 25, 2012
Last verified: May 2012
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: None (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

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All

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 identifier: NCT00175851

Sponsors and Collaborators
UCB Pharma
Study Director: Barbara Bennett, PhD UCB Pharma
  More Information

Responsible Party: Study Director, UCB Identifier: NCT00175851     History of Changes
Other Study ID Numbers: N01197
Not yet available
Study First Received: September 9, 2005
Last Updated: May 25, 2012

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

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on September 21, 2017