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.

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00175864
First received: September 9, 2005
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

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


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
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.

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: February 2006
  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

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.
  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: NCT00175864

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

No publications provided

ClinicalTrials.gov Identifier: NCT00175864     History of Changes
Other Study ID Numbers: N01212, Not yet available
Study First Received: September 9, 2005
Last Updated: March 19, 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 20, 2014