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Assessment Study of Steroid Effect in Relapsing Multiple Sclerosis Subjects Treated With Glatiramer Acetate

NCT00203047 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 414

Last updated 2014-01-06

Study results available
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Summary

This is a study evaluating the effect on brain volume of daily glatiramer acetate (GA) and add-on pulse steroids.

Conditions

  • Relapsing Remitting Multiple Sclerosis

Interventions

DRUG

Glatiramer Acetate

20mg glatiramer acetate (GA) administered by daily subcutaneous injections

DRUG

Placebo

Placebo for prednisone given daily

DRUG

Prednisone

Prednisone 1250 mg taken daily

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Jean-Louis Stril, MD · Teva Neuroscience Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2009-05-31
Completion
2009-05-31

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Entities

Drugs

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 NCT00203047 on ClinicalTrials.gov