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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00289978
First received: February 9, 2006
Last updated: April 9, 2012
Last verified: April 2012
History of Changes
  Purpose

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)


Condition Intervention Phase
Relapsing-remitting Multiple Sclerosis
 Drug: Fingolimod 1.25 mg
Drug: Fingolimod 0.5 mg
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of Fingolimod 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Estimated Annualized Aggregate Relapse Rate (ARR) [ Time Frame: Baseline to end of study (Month 24) ] [ Designated as safety issue: No ]
    The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group calculated as the total number of confirmed relapses divided by the total number of days on study, multiplied by 365.25.


Secondary Outcome Measures:
  • Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS) [ Time Frame: Baseline to end of study (Month 24) ] [ Designated as safety issue: No ]
    EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the following: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. A 3-month confirmed disability progression required onset EDSS, 3-month confirming EDSS, and all EDSS in between to meet the disability progression criteria. Percent of free of disability progression was calculated using the Kaplan Meier method.

  • Number of New or Newly Enlarged T2 Lesions at Month 24 in Comparison With Baseline [ Time Frame: Baseline to end of study (Month 24) ] [ Designated as safety issue: No ]
    The number of new or newly enlarged T2 lesions at Month 24 in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.


Enrollment: 1272
Study Start Date: January 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fingolimod 1.25 mg Drug: Fingolimod 1.25 mg
Patients self-administered fingolimod 1.25 mg capsules orally once daily.
Experimental: Fingolimod 0.5 mg Drug: Fingolimod 0.5 mg
Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Placebo Comparator: Placebo Drug: Placebo
Patients self-administered a fingolimod placebo capsule orally once daily.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis
  • Patients with a relapsing-remitting disease course
  • Patients with EDSS score of 0-5.5

Exclusion Criteria:

  • Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc.
  • Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria applied to this study.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289978

  Show 115 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00289978     History of Changes
Other Study ID Numbers: CFTY720D2301
Study First Received: February 9, 2006
Results First Received: January 4, 2011
Last Updated: April 9, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Novartis:
Multiple Sclerosis
FTY720
Fingolimod

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
 Immune System Diseases
Pathologic Processes
Fingolimod
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013