A Study of TAK-341 in Treatment of Multiple System Atrophy
Purpose
The main aim is to see how TAK-341 works after 52 weeks in participants with multiple system atrophy as measured by the Unified Multiple System Atrophy Rating Scale Part I (UMSARS). The study will enroll approximately 138 patients. Participants will receive a total of 13 intravenous infusions every 4 weeks approximately, these may be either of TAK-341 or placebo, after each infusion some blood samplings will be taken and other assessments completed. This trial will be conducted in North America, Europe and Asia.
Condition
- Multiple System Atrophy
Eligibility
- Eligible Ages
- Over 40 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 specific symptoms and deficits as measured by the UMSARS scale.
Exclusion Criteria
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 α-synuclein (αSYN) for progressive disease (PD) or MSA, or has had immunoglobulin G therapy, within 6 months before screening.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Early PK Cohort: TAK-341 Dose 1 |
Participants will be randomized to receive TAK-341 at a starting Dose 1 at 4 week intervals for up to 52 weeks. |
|
|
Placebo Comparator Early PK Cohort: Placebo |
Participants will be randomized to receive TAK-341 placebo, up to 52 weeks. |
|
|
Experimental Main Cohort: TAK-341 Dose 2 |
Participants will be randomized to receive TAK-341 at a starting Dose 2 at 4 week intervals for up to 52 weeks. |
|
|
Placebo Comparator Main Cohort: Placebo |
Participants will be randomized to receive TAK-341 placebo, up to 52 weeks. |
|
Recruiting Locations
Little Rock, Arkansas 72205
Los Angeles, California 90095
Orlando, Florida 32803
Farmington Hills, Michigan 48025
New York, New York 10016
Durham, North Carolina 27705
Cleveland, Ohio 44195
Dallas, Texas 75390
Spokane, Washington 99202
More Details
- NCT ID
- NCT05526391
- Status
- Recruiting
- Sponsor
- Takeda
Detailed Description
The drug being tested in this study is called TAK-341. The study will evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of intravenous (IV) TAK-341 in participants with multiple system atrophy (MSA). The study will enroll approximately 138 participants. The study comprises a screening period of up to 42 days (6 weeks), a 52-week double-blind treatment period, and a follow-up safety visit. Participants will be randomly assigned (by chance, like flipping a coin) to one of the treatment schedules-which will remain undisclosed to the participant, care provider and investigator during the study: - Early PK Cohort: TAK-341 Dose 1 - Early PK Cohort: Placebo - Main Cohort: TAK-341 Dose 2 - Main Cohort: Placebo The change from baseline in UMSARS will be measured at Week 52 post-dose. This multi-center trial will be conducted worldwide. The duration of treatment in this study will be 52 weeks. Participants will make a follow-up visit to the site after approximately 90 days after the last dose of study treatment. Early-termination participants will not make a follow-up safety visit.