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Conversion to Monotherapy Study With Keppra XR for Partial Seizures

NCT00419094 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2014-09-05

Study results available
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Summary

The primary objective of this study is to assess the efficacy of two doses of Keppra XR compared with a historical control as the placebo, in the monotherapy treatment of partial onset seizures.

Conditions

Interventions

DRUG

Keppra XR

Administered as two 500 mg tablets (1000 mg) and two placebo tablets once daily for 18 weeks

DRUG

Keppra XR

Administered as four 500 mg tablets (2000 mg) once daily for 18 weeks

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · +1 877 822 9493

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States
  • Mexico
  • Poland
  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00419094 on ClinicalTrials.gov