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

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Novartis

Status and phase

Completed
Phase 3

Conditions

Relapsing-remitting Multiple Sclerosis

Treatments

Drug: Fingolimod 0.5 mg
Drug: Placebo
Drug: Fingolimod 1.25 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00289978
CFTY720D2301

Details and patient eligibility

About

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)

Enrollment

1,272 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

1,272 participants in 3 patient groups, including a placebo group

Fingolimod 1.25 mg
Experimental group
Treatment:
Drug: Fingolimod 1.25 mg
Fingolimod 0.5 mg
Experimental group
Treatment:
Drug: Fingolimod 0.5 mg
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

115

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Data sourced from clinicaltrials.gov

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