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Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis

NCT00289978 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1272

Last updated 2012-04-11

Study results available
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Summary

This study assessed the efficacy, safety, and tolerability of 2 doses of oral fingolimod (1.25 mg/day and 0.5 mg/day) compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS)

Conditions

  • Relapsing-remitting Multiple Sclerosis

Interventions

DRUG

Fingolimod 1.25 mg

Patients self-administered fingolimod 1.25 mg capsules orally once daily.

DRUG

Fingolimod 0.5 mg

Patients self-administered fingolimod 0.5 mg capsules orally once daily.

DRUG

Placebo

Patients self-administered a fingolimod placebo capsule orally once daily.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • Australia
  • Belgium
  • Canada
  • Czechia
  • Finland
  • France
  • Germany
  • Greece
  • Israel
  • Lithuania
  • Netherlands
  • Poland
  • Russia
  • Slovakia
  • South Africa
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT00289978 on ClinicalTrials.gov