A Study of TAK-341 in Treatment of Multiple System Atrophy
- Conditions
- Multiple System Atrophy
- Registration Number
- JPRN-jRCT2011220029
- Lead Sponsor
- onomura Hidenori
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 138
Diagnostic:
1.The participant has a diagnosis of possible or probable MSA using the modified Gilman et al, 2008 diagnostic criteria.
2.The participant's onset of first MSA symptoms occurred =<4 years before screening, as assessed by the investigator.
3.Evidence of MSA specific symptoms and deficits as measured by the UMSARS scale.
Medical History:
1.The participant has any contraindication to study procedures.
Diagnostic Assessments:
1.Presence of confounding diagnosis and/or conditions that could affect participant's safety during the study per investigator judgement.
2.The participant's participation in a previous study of a disease-modifying therapy (with proven receipt of active treatment) will compromise the interpretability of the data from the present study, per consultation with medical monitor or designee.
Other:
1.The participant has participated in another study investigating active or passive immunization against alfa-synuclein (alfa-SYN) for progressive disease (PD) or MSA, or has had immunoglobulin G therapy, within 6 months before screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Change from Baseline in a Modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I at Week 52<br>Time Frame: Up to 52 weeks<br>UMSARS Part I (historical review) is a 11-item scale that was adapted from the Unified Parkinson's Disease Rating Scale (UPDRS) and is used to assess activities related to motor disability and related to autonomic dysfunction. Each item is scored from 1 (normal) to 4 (severe). The total score is a sum of scores from all domains and can range from 11 to 44. Higher scores mean poorer health.
- Secondary Outcome Measures
Name Time Method