Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05526391 | A Study of TAK-341 in Treatment of Multiple System Atrophy | PHASE2 | COMPLETED | 158 | — | — | Nov 16, 2022 | Jul 28, 2025 | Jun 2, 2026 | 41 | United States, Austria +8 |
UMSARS Part I (historical review) is a 12-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 autonomic dysfunction. In this study, the UMSARS was modified to exclude the sexual function item. Thus, total 11 items were assessed. Each item was initially scored on a scale from 0 (normal) to 4 (severe); ratings of normal (0) and mild (1) were then combined and recorded as 0, making minimum score 0 and maximum score 3. The investigator rated the average functional situation for the past 2 weeks according to findings from the participant and caregiver interview and indicated the score that best fit with the participant's status. The total score is a sum of scores from all domains and range from 0 to 33. Higher scores indicate worse impairment.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received TAK-341 matching placebo intravenous (IV) infusions, once every 4 weeks (Q4W) for 52 weeks. |
| TAK-341 | EXPERIMENTAL | Participants received TAK-341, IV Q4W for 52 weeks. An early set of participants initially received 2400 milligrams (mg) to determine pharmacokinetic (PK) parameters. Following the early participants, a dose of 2000 mg was given until the data from the PK participants became available. All participants then received 2400 mg until the end of treatment at 52 weeks. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | TAK-341-matching placebo IV infusion |
| TAK-341 | DRUG | TAK-341 IV infusion |
Inclusion criteria: 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 specifi...