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A Study in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Glatiramer Acetate (GA) Injection 40 mg Administered Three Times a Week Compared to Placebo

NCT01067521 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1404

Last updated 2021-12-09

Study results available
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Summary

The study is designed to assess the efficacy of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in subjects with RRMS, as measured by the number of confirmed relapses during the 12 month placebo controlled period. The study has two periods:

* Placebo Controlled Period: 12 months of 40 mg administered three times a week by subcutaneous injection or matching placebo.
* Open Label Extension Period: All subjects will continue treatment with GA 40 mg administered three times a week, until this dose strength is commercially available for the treatment of relapsing remitting multiple sclerosis (RRMS) patients or until the development of this GA dose regimen is stopped by the Sponsor

Conditions

  • Relapsing Remitting Multiple Sclerosis

Interventions

DRUG

Glatiramer acetate (GA)

GA 40 mg/mL administered 3 times a week by subcutaneous injection for a period of 12 months for participants assigned to GA treatment in the Double-Blind Period, and GA 40 mg/mL administered 3 times a week by subcutaneous injection for all participants in the Open-Label Extension Period.

DRUG

Placebo

Placebo comparator administered by subcutaneous injection three times each week for 12 months during the Double-Blind Period.

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-06-22
Primary Completion
2012-05-08
Completion
2017-05-12
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Croatia
  • Czechia
  • Estonia
  • Georgia
  • Germany
  • Hungary
  • Israel
  • Italy
  • Lithuania
  • Poland
  • Romania
  • Russia
  • South Africa
  • Ukraine
  • United Kingdom

Study Locations

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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 NCT01067521 on ClinicalTrials.gov