Trial to Evaluate the Efficacy and Safety of KM-819 Treatment to Slow the Progression of Multiple System Atrophy (MSA)

Last updated: September 12, 2024
Sponsor: Kainos Medicine Inc.
Overall Status: Terminated

Phase

2

Condition

Multiple System Atrophy

Treatment

Placebo

KM-819

Clinical Study ID

NCT05695378
KMCP-819-K102
  • Ages 30-80
  • All Genders

Study Summary

This trial will the efficacy of KM-819 compared to placebo in subjects with MSA for slowing the progression of MSA.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Must be diagnosed as probable or possible MSA, according to the second consensuscriteria for diagnosis of MSA

  2. Patients who are able to visit the clinic during the study period to be in thestudy.

  3. ≥ 30 years and ≤ 80 years of age at the time of signing the Informed Consent

  4. Antiparkinsonian medications should be stable for, at least, one month beforeenrollment.

  5. Body Mass Index (BMI) range of 18.5 to 30 kg/m^2 inclusive at Screening

  6. Patient agrees to use acceptable contraceptive methods during the study

  7. For women, menopause, sterilization confirmed.

  8. For childbearing women, older than 40, and agreed with more than 2 methods ofcontraception below and agreed with no desire to be pregnant during and after thestudy, and, agreed with maintaining medically acceptable methods of contraceptionduring for 90 days after the study.

  9. Cognitive ability for possible to make self-decision, understand and follow theinstruction, to make written signature on consent form.

  10. If no ability to walk, patients must be accompanied by caregiver by wheelchair onschedule.

Exclusion

Exclusion Criteria:

  1. A diagnosis of drug induced parkinsonism by typical neuroleptic treatment orhaloperidol medication.

  2. Women who are pregnant or lactating

  3. History of suicide attempt. Any recent suicidal ideation (a level of 4 or 5) withinthe last 3 months prior to Day 1, or has a positive response ('Yes') to eitherquestion 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 theInvestigator using the C-SSRS at Screening.

  4. Febrile illness or symptomatic viral, bacterial (including upper respiratoryinfection) or fungal (non-cutaneous) infection.

  5. Any clinically significant abnormality following the Investigator's review of thephysical examination and protocol-defined clinical laboratory tests at Screening orsite check-in.

  6. Patient has a mean pulse rate < 40

  7. Patient has a mean corrected QT interval using Fridericia's formula (QTcF) of > 430msec (for males) and > 450 msec (for females).

  8. History of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias ortorsade de pointes, structural heart disease or a family history of Long QTSyndrome.

  9. Positive serology test for hepatitis B surface antigen (HBsAg), anti-hepatitis Avirus (HAV), immunoglobulin M (IgM), anti-hepatitis C virus (HCV) or anti-humanimmunodeficiency virus (HIV).

  10. Known or suspected hypersensitivity to KM-819, or any components of theformulation(s) used.

  11. Patient has a serious medical or surgical condition.

  12. Patients unable to understand the consent form, and determined by investigator withtoo serious problems for participating in the study.

  13. Patients unable to visit the clinical site on schedule due to the no abilitymobilize.

  14. Patients who had brain surgery history.

Study Design

Total Participants: 68
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
February 27, 2023
Estimated Completion Date:
August 19, 2024

Study Description

This is a randomized, double-blind, placebo-controlled phase II trial. This trial will be performed in two part: Main study and Ancillary study.

Main Study: Following a 4-week screening period, subjects will be stratified by MSA subtype (MSA-P, -C [MSA-Parkinsonian type, MSA-cerebellar ataxia]) and randomly assigned in a 1:1 ratio either to KM-819 or Placebo groups.

During a treatment period of 36 weeks, subjects will receive pills of either KM-819 or Placebo for oral administration every day from baseline visit. Following this, there will be a safety follow-up period at Week 40.

Ancillary Study: This ancillary study will provide additional information on the continuing efficacy and safety of KM-819. Subjects in either treatment group in the main study who complete the study are eligible to participate in a follow-up, all-subjects-on-treatment (KM-819), open-label ancillary study.

All subjects in the ancillary study will receive KM-819 for additional 36 weeks regardless of their treatment allocation during the main study. During a treatment period of 36 weeks, subjects will receive pills of KM-819 for oral administration every day from visit at Weeks 40.

Connect with a study center

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, Gyeonggi-do 13497
    Korea, Republic of

    Site Not Available

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