Safety and Efficacy of Fingolimod in MS Patients in China

Multiple Sclerosis (Relapsing Remitting) Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01941004
• Other study ID #: CFTY720D2315
• Status: Withdrawn
• Phase: Phase 3
• First received: September 9, 2013
• Last updated: April 20, 2017
• Start date: June 2014
• Est. completion date: May 2017

Study information

• Verified date: April 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis (Relapsing Remitting)
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

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 (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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of new/newly enlarged T2 MRI lesions over 6 months	Cumulative number of new/newly enlarged T2 lesions over 6 months	6 months
Secondary	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.	6 months
Secondary	number of Gd-enhancing T1 lesions		6 months
Secondary	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	12 months