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.

NCT00175864 | Withdrawn Phase 3

• 2 other identifiers: N01212Not yet available
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Epilepsy

Keywords

Partial Onset, Primary Generalized Seizures, Seletracetam

Outcome Measures

Primary Outcomes (1)

• Safety profile of seletracetam

Secondary Outcomes (1)

• Reduction in seizure frequency

Interventions

Seletracetam (ucb 44212) DRUG

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UCB Pharma: lead

MeSH Terms

Conditions

Epilepsy

Interventions

Seletracetam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Barbara Bennett, PhD

  UCB Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: February 1, 2006
• Last Updated: March 20, 2012

Record last verified: 2012-03