NCT00422110

Brief Summary

This study will evaluate the effectiveness and safety of seletracetam when it is used in addition to other anti-epileptic medications by patients with partial onset seizures. It will also help to determine the best dose to use.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2007

Completed
1.3 years until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
Last Updated

May 28, 2012

Status Verified

May 1, 2012

First QC Date

January 11, 2007

Last Update Submit

May 25, 2012

Conditions

Epilepsies, Partial

Keywords

SeletracetamEpilepsiesPartialEpilepsyFocal

Outcome Measures

Primary Outcomes (1)

  • Evaluate the efficacy of seletracetam compared to placebo in reducing seizure frequency in subjects with partial onset seizures not fully controlled despite treatment with 1 - 2 concomittant AEDs

Secondary Outcomes (1)

  • Explore the dose/clinical response relation; safety and tolerability; effects of treatment on patients' Health-Related Quality of Life (HRQoL)

Interventions

SeletracetamDRUG

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects from 16 to 70 years old
  • Confirmed diagnosis of focal epilepsy
  • Partial seizures uncontrolled while taking 1 or 2 AEDs
  • At least 8 partial seizures during the 8-week baseline period

You may not qualify if:

  • Seizures occurring only in clusters
  • Status epilepticus within 1 year
  • Progressive CNS disorder
  • Other serious or uncontrolled diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Epilepsies, PartialEpilepsy

Interventions

Seletracetam

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Barbara Bennett, PhD

    UCB Pharma

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 11, 2007

First Posted

January 15, 2007

Study Start

May 1, 2008

Last Updated

May 28, 2012

Record last verified: 2012-05