Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis (MS)

Novartis

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: Placebo; Drug: FTY720

Study type: Interventional

Funder types: Industry

Identifiers

NCT00537082

CFTY720D1201

Details and patient eligibility

About

To provide efficacy and safety data of two doses (0.5 mg and 1.25 mg) of FTY720 in Japanese patients with relapsing multiple sclerosis (MS)

Enrollment: 171 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients aged 18-60
• Patients with a diagnosis of multiple sclerosis

Exclusion criteria

• Patients with a history or presence of chronic disease of the immune system other than MS
• Patients with a history or presence of malignancy, pulmonary or heart disease, etc.
• Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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171 participants in 3 patient groups, including a placebo group

FTY720 0.5 mg

Experimental group

Description:

FTY720

Treatment:

Drug: FTY720

FTY720 1.25 mg

Experimental group

Description:

FTY720

Treatment:

Drug: FTY720

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo