Phase 2 Study of TAK-341 for Multiple System Atrophy
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous TAK-341 in Subjects With Multiple System Atrophy
IRAS ID
1005598
Contact name
Andrew Janis
Contact email
Sponsor organisation
Takeda Development Center Americas, Inc.
Eudract number
2022-000336-28
Clinicaltrials.gov Identifier
Research summary
Multiple System Atrophy (MSA ) is a rare disease of the brain that affects multiple functions of the body, including blood pressure, breathing, urinary function, and various body movements. The study drug in this study, TAK-341, is being developed in the hope that it may help to slow disease progression in MSA. It is a monoclonal antibody (a protein made in the laboratory to fight against foreign substances) that specifically targets a substance called α-synuclein which is found in people with MSA and Parkinson’s disease.
There are currently no available therapies on the market that can slow or prevent the progression of MSA, therefore, there is a need for effective treatment options for this disease.
The purpose of this clinical research study is to investigate whether TAK-341 is safe and tolerable, and effective in MSA patients and to investigate how TAK-341 is absorbed, broken down, and eliminated from the body.
The study drug will be given as intravenous (IV) infusions and there are 2 groups in this study:
• Early Pharmacokinetic (PK) Group (check how the body handles the study drug): 15 participants will be assigned by chance (like flipping a coin, which is known as randomisation) to receive either TAK-341 or placebo (placebo is a substance that looks like drug but does not contain any active drug in it) in the ratio 2:1 by a computer.
• Main Group: 123 participants will be randomised in the ratio 1:1; which means you have equal chances of receiving TAK-341 or placebo.
Study procedures include physical examination, blood pressure, heart rate, respiratory rate, temperature, blood and urine sampling, electrocardiogram (ECG), neurological examination (to check how the brain, spinal cord, and nerves are working), eye test, brain MRI scan, lumbar puncture to collect cerebrospinal fluid samples and various questionnaires.
The total study participation time including the follow-up period is approximately 67 weeks for each participant.REC name
London - Westminster Research Ethics Committee
REC reference
22/LO/0563
Date of REC Opinion
31 Oct 2022
REC opinion
Further Information Favourable Opinion