Trial to Evaluate the Efficacy and Safety of KM-819 Treatment to Slow the Progression of Multiple System Atrophy (MSA)
Megadott ok: Sponsor has decided to withdraw the study due to safety issue and re-initiate with a new clinical study
A legfontosabb adatok
- Fázis
- 2. fázis
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A vizsgálat adatai
- Ki végzi
- Kainos Medicine Inc.
- Azonosító
- NCT05695378
- A regiszteradat frissítve
- 2024. szeptember 19.
- Eredeti leírás
This trial will the efficacy of KM-819 compared to placebo in subjects with MSA for slowing the progression of MSA.A teljes eredeti leírásKevesebb
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of KM-819 Treatment to Slow the Progression of Multiple System Atrophy
This trial will the efficacy of KM-819 compared to placebo in subjects with MSA for slowing the progression of MSA.
Bevonási feltételek: Must be diagnosed as probable or possible MSA, according to the second consensus criteria for diagnosis of MSA; Patients who are able to visit the clinic during the study period to be in the study; ≥ 30 years and ≤ 80 years of age at the time of signing the Informed Consent; Antiparkinsonian medications should be stable for, at least, one month before enrollment; Body Mass Index (BMI) range of 18.5 to 30 kg/m\^2 inclusive at Screening; Patient agrees to use acceptable contraceptive methods during the study; For women, menopause, sterilization confirmed; For childbearing women, older than 40, and agreed with more than 2 methods of contraception below and agreed with no desire to be pregnant during and after the study, and, agreed with maintaining medically acceptable methods of contraception during for 90 days after the study; Cognitive ability for possible to make self-decision, understand and follow the instruction, to make written signature on consent form; If no ability to walk, patients must be accompanied by caregiver by wheelchair on schedule.
Kizáró feltételek: A diagnosis of drug induced parkinsonism by typical neuroleptic treatment or haloperidol medication; History of suicide attempt. Any recent suicidal ideation (a level of 4 or 5) within the last 3 months prior to Day 1, or has a positive response ('Yes') to either question 4 or 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) at check-in (Day 1), or who is at significant risk to commit suicide, as judged by the Investigator using the C-SSRS at Screening; Patients who had brain surgery history; Febrile illness or symptomatic viral, bacterial (including upper respiratory infection) or fungal (non-cutaneous) infection; Positive serology test for hepatitis B surface antigen (HBsAg), anti-hepatitis A virus (HAV), immunoglobulin M (IgM), anti-hepatitis C virus (HCV) or anti-human immunodeficiency virus (HIV); Known or suspected hypersensitivity to KM-819, or any components of the formulation(s) used; Patient has a serious medical or surgical condition; Any clinically significant abnormality following the Investigator's review of the physical examination and protocol-defined clinical laboratory tests at Screening or site check-in; Patient has a mean corrected QT interval using Fridericia's formula (QTcF) of > 430 msec (for males) and > 450 msec (for females); History of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsade de pointes, structural heart disease or a family history of Long QT Syndrome; Women who are pregnant or lactating; Patient has a mean pulse rate < 40; Patients unable to understand the consent form, and determined by investigator with too serious problems for participating in the study; Patients unable to visit the clinical site on schedule due to the no ability mobilize.