Safety and Efficacy of Fingolimod in MS Patients in China

A 12 Month Study, With a 6-month, Double-blind, Randomized, Placebo-controlled, Multi-center Parallel- Groups, Treatment Phase Evaluating Efficacy and Safety of Fingolimod 0.5 mg and a 6-month, Open-label, Treatment Phase, in Chinese Patients With Relapsing-remitting Multiple Sclerosis

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01941004

Enrollment

Registered

2013-09-12

Start date

2014-06-30

Completion date

2017-05-31

Last updated

2017-04-21

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

Conditions

Multiple Sclerosis (Relapsing Remitting)

Keywords

multiple sclerosis (MS), relapsing remitting multiple sclerosis (RRMS), fingolimod

Brief summary

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

Interventions

DRUGfingolimod

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

DRUGPlacebo (6mos) + open label fingolimod (6 mos)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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/

Design outcomes

Primary

Measure	Time frame	Description
number of new/newly enlarged T2 MRI lesions over 6 months	6 months	Cumulative number of new/newly enlarged T2 lesions over 6 months

Secondary

Measure	Time frame	Description
annualized relapse rate (ARR)	6 months	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.
number of Gd-enhancing T1 lesions	6 months	—
Safety and tolerability of fingolimod 0.5 mg compared to placebo	12 months	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

Outcome results

None listed

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