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Efficacy and Safety of GTR in Comparison to Copaxone®

NCT01489254 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 794

Last updated 2016-12-29

Study results available
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Summary

The purpose of this study is demonstrate that efficacy and safety of Synthon's glatiramer acetate (GTR) is equivalent to Copaxone® (Teva) in patients with relapsing remitting multiple sclerosis

Conditions

Interventions

DRUG

Glatiramer Acetate (GTR)

Glatiramer Acetate (GTR) 20 mg daily, for 9 months (Part 1) followed by additional 15 month treatment period (Part 2)

DRUG

Glatiramer Acetate (Copaxone®)

Glatiramer Acetate (Copaxone), 20 mg daily, for 9 months followed by additional 15 month GTR 20 mg daily treatment period (Part 2)

DRUG

Placebo

Placebo (daily) for 9 months followed by additional 15 month GTR 20 mg daily treatment period (Part 2)

Sponsors & Collaborators

  • Synthon BV

    lead INDUSTRY

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
2011-10-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States
  • Belarus
  • Bosnia and Herzegovina
  • Bulgaria
  • Croatia
  • Czechia
  • Estonia
  • Georgia
  • Germany
  • Italy
  • Mexico
  • Moldova
  • Poland
  • Romania
  • Russia
  • Serbia
  • South Africa
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT01489254 on ClinicalTrials.gov