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FREEDOMS

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
CompletedPhase 3Relapsing MSNCT00289978

What it found

Met its main goal

The main measure showed a statistically significant benefit.

“The annualized relapse rate was 0.18 with 0.5 mg of fingolimod, 0.16 with 1.25 mg of fingolimod, and 0.40 with placebo (P<0.001 for either dose vs. placebo).”
Read by software from the paper's abstract

annualized relapse rate · 24 months

GroupnValue
placebo0.40

p = <0.001 for either dose vs. placebo

Total participants: 1272

Read by software from the paper's abstract

What was tested

Treatment tested

Placebo or sham

  • Placebo

Results by group

Estimated Annualized Aggregate Relapse Rate (ARR)

Baseline to end of study (Month 24)

GroupValueIntervalNumber analysed
Fingolimod 1.25 mg0.16 Relapses per year0.13–0.19429
Fingolimod 0.5 mg0.18 Relapses per year0.15–0.22425
Placebo0.40 Relapses per year0.34–0.47418

Fingolimod 1.25 mg

0.16

Fingolimod 0.5 mg

0.18

Placebo

0.4

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Fingolimod 1.25 mg42951 (11.9%)
Fingolimod 0.5 mg42543 (10.1%)
Placebo41856 (13.4%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Estimated Annualized Aggregate Relapse Rate (ARR)

    Baseline to end of study (Month 24)

    Relapses

Other measures (2)

  • Percentage of Patients Free of Disability Progression at Month 24 Assessed With the Expanded Disability Status Scale (EDSS)

    Baseline to end of study (Month 24)

    Disability progression

  • Number of New or Newly Enlarged T2 Lesions at Month 24 in Comparison With Baseline

    Baseline to end of study (Month 24)

    MRI lesions

Who could take part

Relapsing MS · 18 to 55

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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)

Papers

Loading reviews and guidelines…

Linked trials

Links found where a registry record names another trial's registry number.

Related trials

History

    1. Started

      Jan 2006

    2. Main results due

      Jul 2009

    3. Finished

      Jul 2009

    4. Results posted

      Mar 2011

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