Randomized, double-blind, placebo-controlled, 3-arm, 36 weeks parallel
Randomized, double-blind, placebo-controlled, 3-arm, 36 weeks parallel-group study to evaluate the safety and tolerability of ORY-2001 in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) and Secondary Progressive Multiple Sclerosis (SPMS)
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Not yet requested
What it measured
Main measures
• Number, frequency and severity of Adverse Events (AEs).
Safety
Other measures (1)
• Cumulative number of Combined Unique Active lesions (CUAL) (defined as Gd-enhancing T1-weighted lesions and non-enhancing new/enlarging T2-weighted lesions) at weeks 8, 12, 24, 32 and 36 as assessed through MRI.
MRI lesions
Who could take part
Relapsing and progressive
Show the full criteria
Inclusion criteria
Inclusion: 1. Patients aged 18-65 years, inclusive Exclusion: 1. Previous history of central nervous system (CNS) or psychiatric clinical disease that according to the investigator might confound the assessment of the study endpoints
Exclusion criteria
Not separately supplied in the registry.
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 tolerability of two doses of ORY-2001 compared to placebo in multiple sclerosis (MS) subjects.
Papers
Loading reviews and guidelines…
History
Started
Jul 2017