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
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
To evaluate the safety and efficacy of fingolimod 0.5mg vs. placebo in MS patients in China
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2014
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2013
CompletedFirst Posted
Study publicly available on registry
September 12, 2013
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedApril 21, 2017
April 1, 2017
2.9 years
September 9, 2013
April 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
annualized relapse rate (ARR)
6 months
number of Gd-enhancing T1 lesions
6 months
Safety and tolerability of fingolimod 0.5 mg compared to placebo
12 months
Study Arms (2)
double blinded Fingolimod 6 mos + open label fingolimod 6 mos
EXPERIMENTALRandomized 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 6 mos + open label fingolimod 6 mos
PLACEBO COMPARATORRandomized to 6 month (180 days) matching placebo + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily
Interventions
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
Randomized to 6 month (180 days) matching placebo + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily
Eligibility Criteria
You may qualify if:
- Patients must have relapsing remitting multiple sclerosis
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2013
First Posted
September 12, 2013
Study Start
June 1, 2014
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
April 21, 2017
Record last verified: 2017-04