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Unknown

KM-819 for Parkinson's Disease

Phase 2

Recruiting

Research Sponsored by FAScinate Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up part 1a and part 1b: from screening (day -42 to -3) up to 7 days and part 2: from screening (day -42 to -2) to 730 days

Awards & highlights

Study Summary

This trial looks at whether a new drug, KM-819, can help stop or slow down Parkinson's Disease. It tests safety and how well people tolerate it.

Who is the study for?

This trial is for healthy adults and those with Parkinson's disease (PD) who are stable on PD medications for at least 8 weeks. Participants should be in early to moderate stages of PD, not have other neurodegenerative disorders or significant cognitive decline, and must agree to use effective contraception.Check my eligibility

What is being tested?

The study tests KM-819's ability to slow down or stop the progression of Parkinson's disease. It compares the effects of different doses of KM-819 against a placebo in both healthy participants and those with PD.See study design

What are the potential side effects?

While specific side effects aren't listed, typical ones may include nausea, headache, dizziness, or allergic reactions. The study aims to determine how well participants tolerate KM-819 and will monitor any adverse reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ part 1a and part 1b: from screening (day -42 to -3) up to 7 days and part 2: from screening (day -42 to -2) to 730 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~part 1a and part 1b: from screening (day -42 to -3) up to 7 days and part 2: from screening (day -42 to -2) to 730 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and part 1a and part 1b: from screening (day -42 to -3) up to 7 days and part 2: from screening (day -42 to -2) to 730 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1a,1b and 2: Number of participants with adverse events and serious adverse events

Part 2: Change from baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II: Activities of Daily Living (ADL) Score at Day 730

Secondary outcome measures

Part 1a and 1b: AUC from pre-dose (time zero) extrapolated to time infinity [AUC(0-inf)]

Part 1a and 1b: AUC from pre-dose (time zero) to 24 hours post-dose [AUC(0-24)]

Part 1a and 1b: AUC normalized to dose administered (AUC_D)

+25 more

Other outcome measures

Digital biomarkers using the Parkinson's Disease Digital Biomarker Solutions from Roche Molecular Solutions.

Trial Design

8Treatment groups

Experimental Treatment

Group I: Part 2: Cohort 2.2 Dose YExperimental Treatment2 Interventions

Participants with Parkinson's disease will receive oral doses of KM-819 (dose to be determined based on the findings from Part 1) or matching placebo once-daily for 730 days and will be allowed to take study intervention with or without fasting.

Group II: Part 2: Cohort 2.1 Dose XExperimental Treatment2 Interventions

Group III: Part 1b: Cohort 1.3b Dose 600 mgExperimental Treatment2 Interventions

Participants with Parkinson's disease will receive oral 600 mg dose of KM-819 or matching placebo once-daily for 7 days, after fasting for 2 hours prior to administration of study intervention and will be required to fast for 1 hour after administration of study intervention.

Group IV: Part 1b: Cohort 1.2b Dose 400 mgExperimental Treatment2 Interventions

Participants with Parkinson's disease will receive oral 400 mg dose of KM-819 or matching placebo once-daily for 7 days, after fasting for 2 hours prior to administration of study intervention and will be required to fast for 1 hour after administration of study intervention.

Group V: Part 1b: Cohort 1.1b Dose 200 mgExperimental Treatment2 Interventions

Participants with Parkinson's disease will receive oral 200 mg dose of KM-819 or matching placebo once-daily for 7 days, after fasting for 2 hours prior to administration of study intervention and will be required to fast for 1 hour after administration of study intervention.

Group VI: Part 1a: Cohort 1.3a Dose 800 mgExperimental Treatment2 Interventions

Healthy older adult participants will receive oral 800 mg dose of KM-819 or matching placebo once-daily for 7 days, after fasting for 2 hours prior to administration of study intervention and will be required to fast for 1 hour after administration of study intervention.

Group VII: Part 1a: Cohort 1.2a Dose 600 mgExperimental Treatment2 Interventions

Healthy older adult participants will receive oral 600 mg dose of KM-819 or matching placebo once-daily for 7 days, after fasting for 2 hours prior to administration of study intervention and will be required to fast for 1 hour after administration of study intervention.

Group VIII: Part 1a: Cohort 1.1a Dose 400 mgExperimental Treatment2 Interventions

Healthy older adult participants will receive oral 400 mg dose of KM-819 or matching placebo once-daily for 7 days, after fasting for 2 hours prior to administration of study intervention and will be required to fast for 1 hour after administration of study intervention.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

KM-819

2016

Completed Phase 1

~90

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

FAScinate Therapeutics Inc.Lead Sponsor

ParexelIndustry Sponsor

304 Previous Clinical Trials

100,858 Total Patients Enrolled

Media Library

KM-819 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05670782 — Phase 2

Parkinson's Disease Research Study Groups: Part 1a: Cohort 1.1a Dose 400 mg, Part 1a: Cohort 1.2a Dose 600 mg, Part 1a: Cohort 1.3a Dose 800 mg, Part 1b: Cohort 1.1b Dose 200 mg, Part 1b: Cohort 1.2b Dose 400 mg, Part 1b: Cohort 1.3b Dose 600 mg, Part 2: Cohort 2.1 Dose X, Part 2: Cohort 2.2 Dose Y

Parkinson's Disease Clinical Trial 2023: KM-819 Highlights & Side Effects. Trial Name: NCT05670782 — Phase 2

KM-819 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05670782 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have the opportunity to participate in this trial?

"That is correct. Clinicaltrials.gov indicates that this medical research, which first appeared on July 19th 2022, is actively seeking participants. The study needs to recruit 330 patients from a single clinical centre."

Answered by AI

What are the implications of administering a 400 mg dose in Part 1a: Cohort 1.1a?

"Considering the Phase 2 status of Part 1a: Cohort 1.1a Dose 400 mg, our team has given it an intermediate safety rating of 2 due to data that demonstrates its security but lacks information regarding efficacy."

Answered by AI

Are there openings available for participants in this clinical trial?

"Affirmative. According to data on clinicaltrials.gov, this research study is currently recruiting 330 participants from a single site since it was first posted in July 19th 2022 and last updated December 21st 2021."

Answered by AI

What results are researchers expecting to uncover through this experiment?

"This study will measure its efficacy over two different part of the trial: Part 1a and 1b, which last from screening (Day -42 to -3) up to 7 days, and Part 2,which runs until Day 730. The primary outcome being assessed is change in Movement Disorder Society-Unified Parkinson's disease Rating Scale (MDS-UPDRS) Activities of Daily Living Score at Day 730. Additionally, secondary outcomes include Area Under Curve(AUC), Maximum Concentration(Cmax), and Time To Achieve Cmax tmax values for KM-819 in plasma across both parts of the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate Safety and Efficacy of KM-819 in Healthy Adults and Participants With Parkinson's Disease

2022. "A Study to Evaluate Safety and Efficacy of KM-819 in Healthy Adults and Participants With Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05670782.