FREEDOMS
Fingolimod
FREEDOMS demonstrated that once-daily oral fingolimod reduced relapses, disability progression, and MRI activity versus placebo.
- Phase
- Phase III
- Population
- Relapsing-remitting multiple sclerosis (RRMS)
- Controlled period
- Jan 2006 — Jul 2009
What was compared
Intervention
Fingolimod 0.5 mg
Orally once daily
Comparator
Placebo
Matching oral capsule once daily
Additional randomized arm
Fingolimod 1.25 mg
Orally once daily1,272 randomized24 months controlled phase
Primary endpoint
Prespecified outcome
Annualized relapse rate
24 months
Outcome figure
Primary endpoint results
Intervention Comparator or reference
Annualized relapse rate
Relapses per participant-year
Both doses reduced relapse rate versus placebo (P<0.001).
Selected secondary outcomes
3-month confirmed disability progression
17.7% with 0.5 mg versus 24.1% with placebo; HR 0.70 (P=0.02).
MRI activity
Both doses were superior to placebo across prespecified MRI measures.
Study population
- Randomized
- 1,272 randomized
- Age
- 18–55 years eligible
- Sex
- 889 women (70%)
- Disability
- EDSS 0–5.5
- Disease definition
- Relapsing-remitting MS with recent clinical activity
Who entered the trial
Key inclusion criteria
- Relapsing-remitting multiple sclerosis
- At least one relapse in 1 year or two relapses in 2 years
- Baseline EDSS 0–5.5
Key exclusion criteria
- Other major immune, malignant, pulmonary, or cardiac disease
- Pregnancy or breastfeeding
- Other protocol-defined safety conditions affecting S1P-modulator treatment
Safety signal
- Bradycardia and atrioventricular conduction block occurred at treatment initiation.
- Macular edema, elevated liver enzymes, and mild hypertension contributed to adverse events and discontinuation.
Why it mattered
FREEDOMS was central to establishing the first oral S1P-receptor modulator as an effective disease-modifying therapy.
Important limitation
Two doses were tested, but only 0.5 mg became the standard MS dose; longer observation was needed to define infrequent and cumulative risks.