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MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone

NCT01633112 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1064

Last updated 2019-05-28

Study results available
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Summary

The purpose of this study was to demonstrate that at least one dose (0.5 mg followed by 0.25 mg) of fingolimod is superior to glatiramer acetate 20 mg SC in reducing the ARR up to 12 months in patients with relapsing-remitting MS

Conditions

  • Relapsing-remitting Multiple Sclerosis (RRMS)

Interventions

DRUG

fingolimod

capsule

DRUG

glatiramer acetate

subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-08-09
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Chile
  • Mexico
  • Puerto Rico

Study Locations

More Related Trials

Entities

Companies

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 NCT01633112 on ClinicalTrials.gov