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

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ClinicalTrials.gov Identifier: NCT00175851
Recruitment Status : Withdrawn
First Posted : September 15, 2005
Last Update Posted : May 28, 2012
Sponsor:
Information provided by:
UCB Pharma

Brief Summary:
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 or disease Intervention/treatment Phase
Epilepsy Drug: Seletracetam (ucb 44212) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Study Start Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
U.S. FDA Resources




Primary Outcome Measures :
  1. Safety profile of seletracetam

Secondary Outcome Measures :
  1. Reduction in seizure frequency


Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00175851


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

Responsible Party: Study Director, UCB
ClinicalTrials.gov Identifier: NCT00175851     History of Changes
Other Study ID Numbers: N01197
Not yet available
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: May 28, 2012
Last Verified: May 2012

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