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Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis

Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Safety, Tolerability and Effect on MRI Lesion Parameters of FTY720 vs Placebo in Patients With Relapsing Multiple Sclerosis Including 18 Month Extension Phase

NCT00333138•Novartis

View on ClinicalTrials.gov

Summary

This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720 in patients with relapsing multiple sclerosis.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Core Study
•Diagnosis of relapsing multiple Sclerosis (MS)
•Patients with at least two documented relapses in the previous 2 years or one documented relapse in the last year
•Patients with an Expanded Disability Status Scale (EDSS) score of 0-6
•Extension Study
•A positive Gd-enhanced MRI scan at screening (in case the first MRI scan obtained at screening was negative, a second scan could have been obtained 1 month later)
•Neurologically stable with no evidence of relapse within 30 days prior to randomization,or during the Screening and Baseline periods.
•Female patients either post-menopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control. Females of childbearing potential with a negative pregnancy test at baseline prior to entry into the treatment period.

Exclusion Criteria

•Core Study
•Patients with other chronic disease of the immune system, malignancies, pulmonary or heart disease, etc
•Pregnant or nursing women
•Extension Study
•Patients who had permanently discontinued study drug prior to the Month 6 visit of the core study
•Patients with diabetes mellitus (to reduce the risk of ME), and therefore ongoing patients with diabetes mellitus or who developed diabetes mellitus were discontinued from the study)

Locations (26)

Novartis Investigational site

Montreal, Canada

Novartis Investigational site

Ottawa, Canada

Novartis Investigational site

Toronto, Canada

Novartis Investigational site

Vancouver, Canada

Novartis Investigational site

Copenhagen, Denmark

Novartis Investigational site

Helsinki, Finland

Novartis Investigational site

Turku, Finland

Novartis Investigational site

Lille, France

Novartis Investigational site

Marseille, France

Novartis Investigational site

Schwendi, Germany

Key Dates

Start Date

May 1, 2003

Primary Completion Date

April 1, 2011

Completion Date

April 1, 2011

Last Updated

September 15, 2017

Enrollment

281

ACTUAL participants

Conditions

Multiple Sclerosis

Interventions

FTY720

DRUG

Placebo

DRUG

Intermittent Hypoxia in Persons With Multiple Sclerosis

NCT06276634

Multiple SclerosisMultiple Sclerosis-Relapsing-Remitting+1 more

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RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

NCT07225504

Secondary Progressive Multiple Sclerosis (SPMS)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis

Inclusion Criteria

Exclusion Criteria

Intermittent Hypoxia in Persons With Multiple Sclerosis

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