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
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Multiple System Atrophy,covid-19
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Age: Between 30 years - 100 years
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Gender: Male or Female
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Other Inclusion Criteria:
- 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.
- The subject is an outpatient of either sex, at least 30 years old, at the time of consent.
- 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 (LPs).
- The subject has a body mass index =18 and =35 kg/m2 at screening.
You may not be eligible for this study if the following are true:
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- The subject has serious or unstable clinically significant illness, including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic or autoimmune disease (eg, multiple sclerosis), hematologic, or other major disease.
- The subject has other medical problems (neurological, visual, orthopedic, psychiatric) that in the opinion of the investigator may significantly interfere with completion of the study or interpretation of study endpoints.
- The subject has a disorder that is likely to interfere with drug disposition and elimination.
- The subject has a history of alcohol or substance use disorder (except nicotine use disorder).
- The subject has attempted suicide within the past year before screening.
- The subject has a positive alcohol or drug screen. A positive result for cannabis or prescription medications does not require exclusion.
- The subject has undergone surgery for the treatment of MSA (eg, pallidotomy, deep brain stimulation, fetal tissue transplantation).
- The subject has a history of epilepsy or seizures, except self-limited febrile childhood seizures.
- Any contraindication to LP, including but not limited to thrombocytopenia or other coagulation disorders (including subjects who are receiving anticoagulants and cannot safely stop them), the presence of cutaneous or soft-tissue infection overlying or adjacent to the site of LP, previous spinal surgery that could complicate access to the subarachnoid space, or conditions associated with raised intracranial pressure, such as a closed head injury within 3 months, or benign intracranial hypertension.
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.