The Effect of the Dose of PI-2301 on Efficacy, Safety, and Tolerability, in Subjects with the Relapsing Remitting Form of Multiple Sclerosis:
What it found
No result yet.
What was tested
Treatment tested
- Plovamer acetate
HLA class II histocompatibility antigen, DRB1-15 beta chain modulator
Compared with
- Glatiramer acetate
Unknown
What it measured
Main measures
MRI: The sum of the total number of gadolinium-enhancing lesions on T1-weighted MRI brain scans at Weeks 24, 28, 32, 36 and 40.
MRI lesions
Who could take part
Relapsing MS
Inclusion: 1. Male or female, between the ages of 18 and 55 years (inclusive). Exclusion: 1. Any MS categorized as secondary progressive (SP), primary progressive (PP), or progressive relapsing (PR).
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The primary objective of this study is to evaluate the efficacy of PI-2301 by magnetic resonance imaging (MRI), as measured by the sum of the number of total gadolinium-enhancing lesions on serial T1-weighted MRI brain scans at Weeks 24 (Visit 9) through 40 (Visit 13) from 2 dose levels of PI-2301 (3 mg and 10 mg) as compared to placebo, in subjects with relapsing remitting multiple sclerosis (RR-MS) when administered study drug weekly for 40 weeks.
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History
Started
Dec 2009
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