MSA-01 in Multiple System Atrophy
ConditionMultiple System Atrophy (MSA)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age30-79
SponsorTokyo University
About this trial
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 criteria
Qualifiers
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.
Patients who are able to discontinue the use of CoQ10 supplements.
Disqualifiers
Patients with severe neurological disorders, other progressive movement disorders, or cognitive impairment.
Patients with severe liver disease.
Patients with a known history of hypersensitivity to any component of the investigational drug.
Pregnant women, breastfeeding women, or women who may be pregnant.
Trial design
Treatments tested in this trial
- MSA-01
- Placebo
Treatment groups
140 Participants
are divided into 2 treatment groupsSponsors and collaborators
Tokyo University
Lead sponsor
Nobelpharma
Collaborator
Source ClinicalTrials.gov