Safety and Efficacy of Fingolimod in MS Patients in China

Novartis

Status and phase: Withdrawn; Phase 3

Conditions: Multiple Sclerosis (Relapsing Remitting)

Treatments: Drug: fingolimod; Drug: Placebo (6mos) + open label fingolimod (6 mos)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01941004

CFTY720D2315

Details and patient eligibility

About

To evaluate the safety and efficacy of fingolimod 0.5mg vs. placebo in MS patients in China

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Patients must have relapsing remitting multiple sclerosis

Exclusion criteria

Patients with:

• History of chronic immune disease
• Certain cancers
• Uncontrolled diabetes
• Certain eye disorders -Negative for varicella
• zoster virus IgG antibodies
• Certain hepatic conditions
• Low white blood cell count
• On certain immunosuppressive medications or heart medications
• Certain heart conditions or certain lung conditions
• Inability to undergo MRI scans -Diagnosis of Neuromyelitis optica.
• Other protocol defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

double blinded Fingolimod 6 mos + open label fingolimod 6 mos

Experimental group

Description:

Randomized to 6 month (180 days) 0.5 mg fingolimod + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily

Treatment:

Drug: fingolimod

Placebo 6 mos + open label fingolimod 6 mos

Placebo Comparator group

Description:

Randomized to 6 month (180 days) matching placebo + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily

Treatment:

Drug: Placebo (6mos) + open label fingolimod (6 mos)