Extension Study of MT-1303
A Phase II, Multicentre Study to Evaluate the Long-term Safety and Efficacy of MT-1303 in Subjects With Relapsing-remitting Multiple Sclerosis Who Have Completed the MT-1303-E04 Study
What it found
The main measure was safety, drug levels or similar, not whether the treatment works.
“One or more adverse events were reported in 303 (82.6%) of 367 patients: 'headache', 'lymphocyte count decreased', 'nasopharyngitis' and 'MS relapse' were most common (14.7%-16.9%).”Read by software from the paper's abstract
96 weeks
Total participants: 415
Read by software from the paper's abstract
What was tested
Treatment tested
- Amiselimod
- MT-1303-Middle
What it measured
Main measures
Safety assessments
Month 18
SafetySafety Assessments
Safety
Other measures (3)
Clinical efficacy
Month 18
RelapsesMagnetic Resonance Imaging (MRI)
Month 18
MRI lesionsBrain volume lossClinical Efficacy Endpoints:
Who could take part
Relapsing MS · 18 to 60
Show the full criteria
Inclusion criteria
* Completion of the 24-week treatment period in MT-1303-E04 as per protocol * Able to provide written informed consent and to comply with the requirements of the protocol * For males and females of reproductive potential, two methods of contraception must be used throughout the study and for 12 weeks after cessation of study medication. At least one of the methods of contraception must be a barrier method.
Exclusion criteria
* Permanent discontinuation of study medication prior to the end of treatment (EOT) visit in MT-1303-E04 * Newly diagnosed diabetes mellitus during MT-1303-E04
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
To evaluate the long-term safety and tolerability of MT-1303 in subjects with relapsing remitting multiple sclerosis (RRMS).
Papers
Results
Two-year results from a phase 2 extension study of oral amiselimod in relapsing multiple sclerosis.Mult Scler · 2018
One or more adverse events were reported in 303 (82.6%) of 367 patients: 'headache', 'lymphocyte count decreased', 'nasopharyngitis' and 'MS relapse' were most common (14.7%-16.9%).
Read by software from the paper's abstract
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History
Started
Aug 2013
Main results due
Mar 2016
Finished
Mar 2016