What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease that focus on neuroprotection and inflammation reduction include MAO-B inhibitors (such as rasagiline and selegiline), cholinesterase inhibitors (like rivastigmine and donepezil), and dopaminergic therapies (including levodopa and dopamine agonists like pramipexole and ropinirole). Known side effects of these treatments can include nausea, dizziness, hallucinations, somnolence, and gastrointestinal issues. Specifically, cholinesterase inhibitors may worsen tremors and cause nausea, while dopamine agonists can lead to edema, constipation, and increased risk of hallucinations.

What prior FDA approvals exist?

Several drugs have been approved by the FDA for the treatment of Parkinson's Disease, focusing on neuroprotection and pathways related to neuronal survival and inflammation reduction. Rasagiline, a monoamine oxidase-B inhibitor, has shown potential neuroprotective effects and is used to manage symptoms and possibly slow disease progression. Additionally, dopamine agonists like pramipexole and ropinirole may offer slight neuroprotective benefits by mimicking dopamine's effects in the brain. While these treatments primarily address symptom management, ongoing research aims to develop more effective neuroprotective therapies.

What other types of research exist?

Promising novel alternatives to KM-819 for Parkinson's Disease treatment include: 1) DJ-1 stimulatory modulators like UCP0054278, which show neuroprotective potential by modulating the oxidized form of DJ-1. 2) SK609, a novel dopamine D3 receptor agonist, which has shown potential in treating motor symptoms of PD. 3) α-synuclein modulating agents, which are being investigated for their disease-modifying properties. 4) Neuroinflammation modulators and neurotrophic factors, which are also under investigation for their potential to alter disease progression.

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Unknown

KM-819 for Parkinson's Disease

Phase 2

Waitlist Available

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

Summary

This trial is testing KM-819, a new drug, to see if it can stop or slow down Parkinson's disease. It involves healthy older adults and people with Parkinson's disease. Researchers aim to find out if KM-819 is safe and can improve symptoms and daily function in these patients.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 study objectives

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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Parkinson's Disease (PD) primarily focus on dopaminergic therapies, which aim to replenish or mimic dopamine, a neurotransmitter that is deficient in PD. Levodopa, often combined with carbidopa, is the most potent and directly converts to dopamine in the brain. Dopamine agonists (e.g., pramipexole, ropinirole) stimulate dopamine receptors, while MAO-B inhibitors (e.g., rasagiline, selegiline) prevent the breakdown of dopamine. These treatments alleviate symptoms but do not halt disease progression. Neuroprotective strategies, like those being studied with KM-819, aim to slow or stop neurodegeneration by targeting pathways involved in neuronal survival and reducing inflammation. This approach is crucial as it addresses the underlying disease mechanisms, potentially preserving neuronal function and improving long-term outcomes for PD patients.

Development and characterization of an inducible Dicer conditional knockout mouse model of Parkinson's disease: validation of the antiparkinsonian effects of a sigma-1 receptor agonist and dihydromyricetin.Rasagiline and selegiline modulate mitochondrial homeostasis, intervene apoptosis system and mitigate α-synuclein cytotoxicity in disease-modifying therapy for Parkinson's disease.Advances in drug development for Parkinson's disease: present status.