Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients

Phase 3CompletedNCT01127750

Novartis2,417 enrolled

Overview

This study will assess tolerability and safety and health outcomes in relapsing MS patients taking FTY720.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

2,417

Conditions

Relapsing Multiple Sclerosis

Interventions

FTY720DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18-65 years of age, must have relapsing MS Exclusion Criteria: * Patients with a type of MS that is not relapsing * Patients with history of chronic immune disease * Patients with a history of certain cancers * Diabetic patients with certain eye disorders * Patients who are on certain immunosuppressive medications or heart medications * Patients with certain heart conditions * Patients with certain lung conditions Other protocol-defined inclusion/exclusion criteria may apply.

Locations (289)

Outcomes

Primary Outcomes

Evaluate the safety and tolerability profile of FTY720 in patients with relapsing forms of MS

Time frame: 4 months

Secondary Outcomes

Incidence of macular edema

Time frame: 4 months

Incidence of bradyarrhythmic electrocardiograms (ECGs)

Time frame: 4 months

Patient reported outcomes indices in multiple sclerosis (PRIMUS), short form health survey-12, and treatment satisfaction questionnaire for medication (TSQM-9)

Time frame: 4 months

Data from ClinicalTrials.gov

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Novartis Investigative Site

Box Hill, Australia

Novartis Investigative Site

Heidelberg, Australia

Novartis Investigative Site

Kogarah, Australia

Novartis Investigative Site

Liverpool, Australia

Novartis Investigative Site

Woodville South, Australia

Novartis Investigational Site

Linz, Austria

Novartis Investigational Site

Vienna, Austria

Novartis Investigational Site

Vienna, Austria

Novartis Investigational Site

Bruges, Belgium

Novartis Investigational Site

Brussels, Belgium

...and 279 more locations