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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • MSA-01

    Drug

    Ubiquinol

  • Placebo

    Drug

    Placebo

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: MSA-01Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline to Week 52 in the Unified Multiple System Atrophy Rating Scale (UMSARS) Part 2 score

Time frame
Baseline to Week 52

Secondary outcomes

1

Change from baseline to Week 52 in the Barthel Index

Time frame
Baseline to Week 52
2

Change from baseline to Week 52 in the Scale for the Assessment and Rating of Ataxia (SARA) score

Time frame
Baseline to Week 52
3

Change from baseline to Week 52 in the Unified Multiple System Atrophy Rating Scale (UMSARS) Part 1 score

Time frame
Baseline to Week 52

Other outcomes

1

Change from baseline in individual UMSARS Part 2 item scores

Time frame
Baseline to Week 52
2

Change from baseline in individual UMSARS Part 1 item scores

Time frame
Baseline to Week 52
3

Change from baseline in the scores of the four ADL-related items of UMSARS Part 1

Time frame
Baseline to Week 52
4

Change from baseline in the scores of the eight QOL-related items of UMSARS Part 1

Time frame
Baseline to Week 52

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tokyo University

Lead sponsor

Nobelpharma

Collaborator

Source ClinicalTrials.gov
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