This is a Randomized Study Comparing Two Doses of INT131 ( 3 mg and 1
A 6-month, Double-blind, Randomized, Parallel-group, Multicenter Study Comparing Safety and Efficacy of Monotherapy With INT131 1 mg or 3 mg or Placebo Administered Orally Once Daily in Treatment Naïve Patients (Who Never Received Disease Modifying Treatment) With Relapsing-Remitting Multiple Sclerosis
What it found
We found no results in the registry or in papers.
This trial finished 9 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Int131
Peroxisome proliferator-activated receptor gamma modulator
What it measured
Main measures
The number of new gadolinium CE T1 weighted lesions
asline to 6 months
MRI lesions
Who could take part
Relapsing MS · 18 to 50
Show the full criteria
Inclusion criteria
1. Signed informed consent before any study procedures 2. Male and female subjects aged 18-50 3. Subjects with a diagnosis of RRMS of three (3) years or less based on date of diagnosis 4. At least one gadolinium-positive lesion within twelve months of enrollment in the study documented in subject's clinical chart
Exclusion criteria
1. Subjects with a history or presence of chronic disease of the immune system other than RRMS 2. Subjects with a diagnosis of primary or secondary progressive multiple sclerosis 3. Ten (10) or more active gadolinium CE MRI-detected lesions on baseline MRI obtained on visit 2
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This is a randomized, double-blind, parallel group study comparing two doses of INT131( 3 mg and 1 mg) administered orally (PO) daily (QD) versus placebo 1 tablet PO QD in subjects with treatment-naïve RRMS for ≤ 3 years.
Papers
Loading reviews and guidelines…
History
Started
Feb 2015
Main results due
Dec 2016
Finished
Dec 2016