Safety and Efficacy of Fingolimod in MS Patients in China

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT01941004
• Collaborator: (none)
• Enrollment: 0
• Arms: 2
• Duration (Months): 35

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis (Relapsing Remitting)	Drug: fingolimod; Drug: Placebo (6mos) + open label fingolimod (6 mos)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Jun 1, 2014
• Anticipated Primary Completion Date: May 1, 2017
• Anticipated Study Completion Date: May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: double blinded Fingolimod 6 mos + open label fingolimod 6 mos 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	Drug: 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
Placebo Comparator: Placebo 6 mos + 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	Drug: 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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. number of Gd-enhancing T1 lesions [6 months]

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01941004
• Other Study ID Numbers: CFTY720D2315
• First Posted: Sep 12, 2013
• Last Update Posted: Apr 21, 2017
• Last Verified: Apr 1, 2017

• Keywords provided by Novartis Pharmaceuticals: multiple sclerosis (MS); relapsing remitting multiple sclerosis (RRMS); fingolimod
• Additional relevant MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis; Fingolimod Hydrochloride

Study Results

No Results Posted as of Apr 21, 2017