A Study of A4I Antagonist in Patients With Relapsing Multiple Sclerosi
A Randomized, Double-blind, Placebo Controlled Dose-ranging Study to Determine the Effect on MRI Lesions and Safety of A4I Antagonist in Relapsing Multiple Sclerosis.
What it found
The trial ended early for another reason (see below).
What was tested
Treatment tested
- A4I Antagonist
What it measured
Main measures
Cumulative number of new gadolinium-enhancing MRI lesions during double-blind treatment period
MRI lesions
Other measures (1)
No. of new active MRI lesions; no. of patients with >=1 objective/subjective MS attack; total no. of MS attacks; no. of patients requiring systemic corticosteroids; change from baseline to wk 12 in EDSS
Disability progressionRelapsesMRI lesions
Who could take part
Relapsing MS · 18 to 59
Show the full criteria
Inclusion criteria
* adult patients, 18-59 years of age; * relapsing multiple sclerosis patients with types 1-4 (established through McDonald criteria); * >=1 MS attack or a Gd-enhancing MRI lesion between 1 month and 1 year before enrollment; * EDSS score of \<=6.5; * inadequate response to approved treatment(Canada only).
Exclusion criteria
* MS attack within 1 month before enrollment; * systemic corticosteroids within 1 month before enrollment; * MS treatments (non-symptomatic) within specified periods before enrollment; * an infection requiring systemic anti-infective treatment or vaccination with a live vaccine within 1 month before enrollment.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This study will compare the effect of A4I antagonist and placebo on MRI lesions,on clinical endpoints, and safety in patients with relapsing Multiple Sclerosis (MS). Eligible patients will be randomized to receive placebo or A4I antagonist, 20mg, 80mg or 300mg, po bid. Patients will undergo MRI brain scans and MS clinical evaluations at intervals throughout the study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Papers
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History
Started
Oct 2007