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

Novartis

Status and phase: Completed; Phase 3

Conditions: Relapsing Multiple Sclerosis

Treatments: Drug: FTY720

Study type: Interventional

Funder types: Industry

Identifiers

NCT01127750

CFTY720D2316

2010-019029-32 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 2,417 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,417 participants in 1 patient group

FTY720

Experimental group

Treatment:

Drug: FTY720