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

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ClinicalTrials.gov Identifier: NCT00289978
Recruitment Status : Completed
First Posted : February 10, 2006
Results First Posted : March 16, 2011
Last Update Posted : April 11, 2012
Information provided by (Responsible Party):

Brief 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)

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : January 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Estimated Annualized Aggregate Relapse Rate (ARR) [ Time Frame: Baseline to end of study (Month 24) ]
    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 :
  1. 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) ]
    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.

  2. Number of New or Newly Enlarged T2 Lesions at Month 24 in Comparison With Baseline [ Time Frame: Baseline to end of study (Month 24) ]
    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.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289978

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Sponsors and Collaborators
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Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00289978    
Other Study ID Numbers: CFTY720D2301
First Posted: February 10, 2006    Key Record Dates
Results First Posted: March 16, 2011
Last Update Posted: April 11, 2012
Last Verified: April 2012
Keywords provided by Novartis:
Multiple Sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Fingolimod Hydrochloride
Sphingosine 1 Phosphate Receptor Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs