MSA-01 to try to slow progression of Multiple System Atrophy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial randomizing about 140 participants 1:1 to oral MSA-01 or placebo for 52 weeks. The primary outcome is change from baseline to Week 52 in the UMSARS Part 2 motor score, with secondary clinical scales and safety assessments also collected. Participants attend regular clinic visits, keep a medication/side-effect diary, and efficacy will be analyzed using a mixed-effects model for repeated measures. The trial builds on a Phase 2 signal of acceptable safety and potential benefit for ubiquinol in MSA.

Why it matters

Who can join: the full rules

Inclusion Criteria:

At the time of informed consent

1. Patients diagnosed as 'clinically established' or 'clinically probable' MSA based on the revised MSA diagnostic criteria of the Movement Disorder Society (MDS).
2. Patients who are able to walk independently or with the use of assistive devices.
3. Patients who are able to attend outpatient visits at the participating study site.

   At the start of study drug administration
4. Patients who are able to discontinue the use of CoQ10 supplements.

Exclusion Criteria:

1. Patients with severe neurological disorders, other progressive movement disorders, or cognitive impairment.
2. Patients with severe liver disease.
3. Patients with a known history of hypersensitivity to any component of the investigational drug.
4. Pregnant women, breastfeeding women, or women who may be pregnant.
5. Patients who have previously participated in a clinical trial of MSA-01.

Where it's running

• The University of Tokyo Hospital
  Bunkyō-Ku, Tokyo, Japan Recruiting
• Nagoya University Hospital
  Nagoya, Aichi-ken, Japan Not yet recruiting
• Chiba University Hospital
  Chiba, Chiba, Japan Not yet recruiting
• Kyushu University Hospital
  Fukuoka, Fukuoka, Japan Not yet recruiting
• Hokkaido University Hospital
  Sapporo, Hokkaido, Japan Not yet recruiting
• Kagoshima University Hospital
  Kagoshima, Kagoshima-ken, Japan Not yet recruiting

Study contacts

• Study coordinator: Jun Mitsui
• Email: msa-office@umin.ac.jp
• Phone: +81-3-5800-9762

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Imaging with MODAG-009 PET to See Synuclein in PD, MSA, and Healthy Adults

  This study tests a new PET tracer, MODAG-009, in people with Parkinson's, Multiple System Atrophy, and healthy adults to see how well it images synuclein in the brain.

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• SST001 PET tracer safety and pharmacokinetics in healthy adults and people with PD or MSA

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• Aleeto for Parkinsonian multiple system atrophy (MSA-P)

  This study will test whether Aleeto is safe and might help people with the Parkinsonian form of multiple system atrophy.

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• Multidisciplinary care for patients with Multiple System Atrophy

  This study looks at how well specialized care helps people with Multiple System Atrophy feel and live better, while also checking how it affects their caregivers over five years.

  Recruiting University of Texas Southwestern Medical Center · Dallas, Texas · NCT03811808

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.