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An Efficacy, Safety and Tolerability Study of Glatiramer Acetate (GA) 20 mg/0.5 ml New Formulation Administered Daily by Subcutaneous (SC) Injection in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)

NCT01578785 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2014-04-02

Study results available
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Summary

This study will investigate the efficacy, safety and tolerability of a new formulation of glatiramer acetate administered at 20 mg/0.5 ml daily versus placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS).

Conditions

  • Relapsing-Remitting Multiple Sclerosis

Interventions

DRUG

Glatiramer Acetate

Glatiramer acetate 20mg in 0.5ml for subcutaneous injection in a pre-filled syringe (PFS) is administered daily. Each PFS also contains 20mg mannitol dissolved in water for injection.

DRUG

Placebo

Matching placebo injection; 20 mg mannitol dissolved in 0.5 mL water for subcutaneous injection in a PFS is administered daily.

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Alexey Boyko, MD · Department of Neurology, Russian State Medical University

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
2012-03-31
Primary Completion
2012-10-31
Completion
2012-11-30

Countries

  • United States
  • Albania
  • Belarus
  • Bosnia and Herzegovina
  • Bulgaria
  • Croatia
  • Estonia
  • Georgia
  • Greece
  • Latvia
  • Mexico
  • Moldova
  • Montenegro
  • North Macedonia
  • Poland
  • Romania
  • Russia
  • Serbia
  • Ukraine

Study Locations

More Related Trials

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 NCT01578785 on ClinicalTrials.gov