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

A 4-month, Open-label, Multi-center Study to Explore Tolerability and Safety and Health Outcomes of FTY720 in Patients With Relapsing Forms of Multiple Sclerosis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01127750

Enrollment

2417

Registered

2010-05-21

Start date

2010-05-31

Completion date

2011-10-31

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing Multiple Sclerosis

Keywords

Relapsing multiple sclerosis, MS, safety, tolerability, health outcomes

Brief summary

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

Interventions

DRUGFTY720

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Evaluate the safety and tolerability profile of FTY720 in patients with relapsing forms of MS	4 months

Secondary

Measure	Time frame
Incidence of macular edema	4 months
Incidence of bradyarrhythmic electrocardiograms (ECGs)	4 months
Patient reported outcomes indices in multiple sclerosis (PRIMUS), short form health survey-12, and treatment satisfaction questionnaire for medication (TSQM-9)	4 months

Countries

Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026