Safety and Efficacy of Fingolimod in MS Patients in China
What it found
The trial ended early for another reason (see below).
What was tested
Treatment tested
Placebo or sham
- Placebo (6mos) + open label fingolimod (6 mos)
What it measured
Main measures
number of new/newly enlarged T2 MRI lesions over 6 months
6 months
MRI lesions
Other measures (3)
annualized relapse rate (ARR)
6 months
Relapsesnumber of Gd-enhancing T1 lesions
6 months
MRI lesionsSafety and tolerability of fingolimod 0.5 mg compared to placebo
12 months
Safety
Who could take part
Relapsing MS · 18 to 50
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
To evaluate the safety and efficacy of fingolimod 0.5mg vs. placebo in MS patients in China
Papers
Loading reviews and guidelines…
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History
Started
Jun 2014
Main results due
May 2017
Finished
May 2017
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