Find Multiple System Atrophy Clinical Trials Near You
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study of MSA-01 in Patients With Multiple System Atrophy
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate whether MSA-01 slows the progression of multiple system atrophy (MSA) and to assess its safety. The primary question is: • Does MSA-01 slow the progression of motor impairment as measured by UMSARS Part 2 score? Participants will be randomly assigned to receive MSA-01 or placebo for 12 months. They will attend regular clinic visits for safety and efficacy assessments and record their medication use and any side effects in a diary.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 79
Healthy Volunteers: f
View:
⁃ At the time of informed consent
• Patients diagnosed as 'clinically established' or 'clinically probable' MSA based on the revised MSA diagnostic criteria of the Movement Disorder Society (MDS).
• Patients who are able to walk independently or with the use of assistive devices.
• Patients who are able to attend outpatient visits at the participating study site.
• At the start of study drug administration
• Patients who are able to discontinue the use of CoQ10 supplements.
Locations
Other Locations
Japan
Institute of Science Tokyo Hospital
NOT_YET_RECRUITING
Bunkyō-ku
The University of Tokyo Hospital
RECRUITING
Bunkyō-ku
Chiba University Hospital
NOT_YET_RECRUITING
Chiba
Kyushu University Hospital
NOT_YET_RECRUITING
Fukuoka
NHO Higashisaitama National Hospital
NOT_YET_RECRUITING
Hasuda
Kagoshima University Hospital
NOT_YET_RECRUITING
Kagoshima
National Center Hospital, National Center of Neurology and Psychiatry