Safety and Efficacy of Fingolimod in MS Patients in China

Phase 3WithdrawnNCT01941004

Novartis Pharmaceuticals

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Multiple Sclerosis (Relapsing Remitting)

Interventions

fingolimodDRUG

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

Placebo (6mos) + open label fingolimod (6 mos)DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

number of new/newly enlarged T2 MRI lesions over 6 months

Cumulative number of new/newly enlarged T2 lesions over 6 months

Time frame: 6 months

Secondary Outcomes

annualized relapse rate (ARR)

The annualized relapse rate (ARR) is identified as the average number of confirmed relapses per year (the total number of confirmed relapses divided by the total days in the study multiplied by 365.25). The number of relapses will include all the confirmed relapses during the study. The time spent in the study will correspond to the observation period for all the relapses from first dose on the study drug to end of study.

Time frame: 6 months

number of Gd-enhancing T1 lesions

Time frame: 6 months

Safety and tolerability of fingolimod 0.5 mg compared to placebo

Based on frequency of adverse events (the number and percentage of patients having any AE by primary system organ class and preferred term) and on the incidence of clinically notable abnormalities

Time frame: 12 months

Data from ClinicalTrials.gov

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