Open Label Study (Everyone Who Participates Receives Drug) to Further Determine How Safe and Effective Oral Treatment of Seletracetam is in Patients With Refractory Epilepsy.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00175864
Recruitment Status : Withdrawn
First Posted : September 15, 2005
Last Update Posted : March 20, 2012
Information provided by:
UCB Pharma

Brief Summary:
This is a safety and efficacy study of add on therapy with seletracetam in patients experiencing refractory epilepsy.

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)
Primary Purpose: Treatment
Official Title: Open Label, Multicenter Study of the Safety and Efficacy of Oral Treatment With Immediate Release Seletracetam (Ucb 44212) at Individualized Doses up to a Maximum of 160mg/Day in Refractory Epileptic Patients.
Study Start Date : February 2006

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 to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • An IRB/IEC approved written informed consent form signed and dated Male/Female patients age 18 (or 16 years where permitted by law) to 65.
  • Minimum body weight of 40 kg.
  • Patients with a confirmed diagnosis of refractory epilepsy of ≥ 6 months.
  • Patients must be receiving 1 - 3 concomitant AEDs.
  • Female patients without childbearing potentials (2 years post-menopausal or surgical sterilization) are eligible. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method.

Exclusion Criteria:

  • Seizures occurring in clusters (seizures occurring either too frequently or indistinctly separated to be reliably counted).
  • Status epilepticus within 3 months of Visit 1.
  • History of non-epileptic seizures.
  • Patients on vigabatrin.
  • Patients on felbamate, unless treatment has been continuous for ≥ 18 months.
  • Use of benzodiazepines (for any indication) taken at a higher frequency than an average of once a week, unless counted as one of the concomitant AEDs.
  • Ongoing psychiatric disease other than mild controlled disorders.
  • Patients with a clinically significant organ dysfunction.
  • Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients.
  • Pregnant or lactating women. Any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control.

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 identifier (NCT number): NCT00175864

Sponsors and Collaborators
UCB Pharma
Study Director: Barbara Bennett, PhD UCB Pharma Identifier: NCT00175864     History of Changes
Other Study ID Numbers: N01212
Not yet available
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: March 20, 2012
Last Verified: March 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