A RANDOMIZED DOUBLE BLIND, PLACEBO-CONTROLLED NATIONAL MULTICENTER PHASE 3 TRIAL TO EVALUATE THE EFFICACY OF AZATHIOPRINE FOR THE PREVENTION OF RELAPSE IN PATIENTS WITH MYELIN OLIGODENDROCYTE GLYCOPROTEIN ANTIBODY ASSOCIATED DISEASE (MOG-AD) AFTER A FIRST ATTACK : MOGWAI

neurology

The primary endpoint is the time to first relapse, comparing azathioprine-treated vs placebo-treated patients during a randomized control period of a maximum of three years.

Number and type of adverse events, including serious adverse events, related to azathioprine and/or steroids., • Global disability at M36 assessed by EDSS (Expanded Disability Status Scale) • Worsening from baseline to M36 of the EDSS • Ambulation status at M36 assessed by the Ambulation Score based on a measurement of the distance the patient is able to walk. • Worsening from baseline to M36 of the Ambulation Score., • Best-corrected high contrast visual acuity at M36 measured using the standard Snellen chart or equivalent. • Worsening from baseline to M36 of visual disability assessed by change of the best- corrected high-contrast visual acuity using the standard Snellen chart or equivalent. • Best-corrected low-contrast visual acuity at M36 using the Sloan Charts at 2.5%, in each eye. • Worsening from baseline to M36 of low-contrast visual acuity using the Sloan Charts at 2.5%, in each eye. • Inner retina, Quality of life will be assessed using the EuroQOL EQ-5D-3L at M36, Compliance to treatment will be described in both arms by the percentage of untaken tablets (left in the blisters) regarding each patient’s time of participation in the study.

No related papers found yet.

France