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

Takeda Development Center Americas, Inc.0 sites138 target enrollmentAugust 1, 2022

ConditionsMultiple System Atrophy MedDRA version: 21.1Level: PTClassification code 10064060Term: Multiple system atrophySystem Organ Class: 10029205 - Nervous system disorders Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Multiple System Atrophy
Sponsor: Takeda Development Center Americas, Inc.
Enrollment: 138
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 1, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Takeda Development Center Americas, Inc.

Eligibility Criteria

Inclusion Criteria

•1\. The subject (or, when applicable, the subject’s legally acceptable representative) signs an informed (e)consent form indicating that the subject has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts. (additionally for subjects in Germany or Austria: the subject has been informed of the nature, significance, and
•implications of the clinical study and is willing and able to understand and fully comply with study procedures and requirements (including
•digital tools and applications) in the opinion of the investigator. If the subject becomes incompetent over the course of the study, a legally
•authorized court\-appointed representative or an appointed agent in health matters (ie, legally acceptable representative) will need to be
•identified and the subject will need to provide assent, in accordance with the local regulations, guidelines, and the IRB/IEC to provide informed
•consent on the subject's behalf to continue in the clinical study).
•2\. The subject is an outpatient of either sex, at least 40 years old, at the time of consent.
•3\. Subjects must, in the opinion of the investigator, be able to participate in all scheduled evaluations, likely to be compliant, and likely to complete all required tests, including neuroimaging brain scans and lumbar punctures.
•4\. The subject has a body mass index \=18 and \=35 kg/m2 at screening.
•5\. The subject has a diagnosis of possible or probable MSA using the modified Gilman et al, 2008 diagnostic criteria.

Exclusion Criteria

•1\. The subject has serious or unstable clinically significant illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic or autoimmune (eg, multiple sclerosis), hematologic, or other major disease, which, in the judgment of the investigator, is poorly controlled or otherwise likely to deteriorate, compromises the subject’s safety or ability to complete the study, or compromises the interpretation of the study results.
•2\. The subject has medical problems (neurological, visual, orthopedic, psychiatric) that may significantly interfere with completion of the study or interpretation of study endpoints or may confound diagnosis.
•3\. The subject has a disorder that is likely to interfere with drug disposition and elimination.
•4\. In the opinion of the investigator, the subject has a diagnosis of depression or other psychiatric disorder, as defined by DSM\-5, AND this disorder is poorly controlled and of sufficient severity to interfere with completion of the study or interpretation of the endpoints.
•5\. The subject is considered by the investigator to be a imminent risk of suicide or injury to self, others, or property, or the subject has attempted suicide within the past year before screening.
•6\. The subject has a history of alcohol or substance use disorder (except tobacco use disorder), as defined by the DSM\-5, within 1 year before screening or between screening and randomization
•7\. The subject has positive finding on an alcohol or illicit drug screen.
•8\. The subject has undergone surgery for the treatment of MSA (eg, pallidotomy, deep brain stimulation, fetal tissue transplantation).
•9\. History of epilepsy or seizures, except self\-limited febrile childhood seizures.
•10\. Contraindication to lumbar puncture (as assessed by the Investigator). A subject whose CSF cannot be collected will be excluded.