NCT00600509

Brief Summary

Double-blind, randomized, placebo-controlled, multi center trial to evaluate the efficacy and safety of levetiracetam as adjunctive treatment in adult Japanese epileptic subjects with partial onset seizures.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2001

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 25, 2008

Completed
Last Updated

September 17, 2013

Status Verified

September 1, 2009

Enrollment Period

2.5 years

First QC Date

January 14, 2008

Last Update Submit

September 16, 2013

Conditions

Epilepsy

Keywords

LevetiracetamKeppra

Outcome Measures

Primary Outcomes (1)

  • partial onset seizure frequency per week

    collection of seizure count throughout the whole study (baseline and treatment periods)

Secondary Outcomes (1)

  • safety and tolerability

    safety and tolerability data were collected throughout the study period

Interventions

LevetiracetamDRUG

Eligibility Criteria

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

You may qualify if:

  • simple and/or complex partial seizures with or without secondary generalization, and first partial seizure \>= 2 years before selection visit;
  • seizures classifiable according to the ILAE classification;
  • minimum of 12 partial seizures per 12 weeks with a minimum of two partial seizures per 4 weeks from the selection visit to the end of the baseline period ;
  • exposed to two or more standard AEDs;
  • taking up to three of the standard AEDs, at the initiation of the trial.

You may not qualify if:

  • medication influencing the CNS, except for medication taken for antiepileptic treatment;
  • partial seizures uncountable due to clustering, including status epileptics, during the 3 months prior to the selection visit;
  • history of cerebrovascular disease including transient ischemic attack (TIA) and progressive cerebral disorder or progressive neurological disorder;
  • presence or history of any clinically significant allergic condition and complication or history of significant alcohol abuse or drug abuse in the past.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Epilepsy

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • UCB Clinical Trial Call Center

    +1 877 822 9493 (UCB)

    STUDY DIRECTOR

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 14, 2008

First Posted

January 25, 2008

Study Start

January 1, 2001

Primary Completion

July 1, 2003

Study Completion

July 1, 2003

Last Updated

September 17, 2013

Record last verified: 2009-09