Safety and Efficacy of Fingolimod in MS Patients in China

Phase 3

Withdrawn

• Conditions: Multiple Sclerosis (Relapsing Remitting)
• Interventions: Drug: Placebo (6mos) + open label fingolimod (6 mos); Drug: fingolimod

• Registration Number: NCT01941004
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-09
• Study First Submitted QC: 2013-09-09
• Study First Posted: 2013-09-12
• Study Start: 2014-06
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-20
• Last Update Posted: 2017-04-21
• Primary Completion: 2017-05
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Patients must have relapsing remitting multiple sclerosis

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo 6 mos + open label fingolimod 6 mos	Placebo (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
double blinded Fingolimod 6 mos + open label fingolimod 6 mos	fingolimod	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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