What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease, such as levodopa, dopamine agonists, and cholinesterase inhibitors, have a range of side effects. Levodopa can cause nausea, dizziness, headache, and more serious effects like confusion, hallucinations, and orthostatic hypotension. Dopamine agonists may lead to somnolence, edema, constipation, dizziness, hallucinations, and nausea. Cholinesterase inhibitors, used for cognitive symptoms, can worsen tremors and cause nausea and vomiting. These side effects highlight the importance of monitoring and individualized treatment plans.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Parkinson's Disease, focusing on both motor and non-motor symptoms. Key treatments include Levodopa combined with Carbidopa, which remains the most effective therapy for motor symptoms. Dopamine agonists like pramipexole and ropinirole, and MAO-B inhibitors such as selegiline and rasagiline, are also approved to manage motor symptoms. For non-motor symptoms, drugs like donepezil and rivastigmine are used to address cognitive impairment. The investigational drug IkT-148009 is being studied for its comprehensive effects on both motor and non-motor symptoms, similar to these existing treatments.

What other types of research exist?

Promising novel alternatives to IkT-148009 for Parkinson's Disease patients include: 1) Dipraglurant, which has shown safety and efficacy in reducing levodopa-induced dyskinesia in a Phase 2A trial. 2) CQA 206-291, an ergot derivative with potent anti-parkinsonian properties, studied in both acute and longer-term trials. 3) S90049, a sublingual formulation of piribedil, which provides rapid relief of motor symptoms during OFF episodes. 4) ONO-2160/carbidopa, a levodopa pro-drug designed to stabilize plasma concentration fluctuations. 5) Sarizotan, which has shown improvements in dyskinesia with its 5-HT(1A) agonist properties and affinity for D(3) and D(4) receptors.

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IkT-148009 for Parkinson's Disease

Phase 2

Waitlist Available

Led By Milton Werner, PhD

Research Sponsored by Inhibikase Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Participants diagnosed with PD consistent with UK Brain Bank criteria and MDS Research Criteria; must include bradykinesia with sequence effect and motor asymmetry

Receiving no anti-parkinsonian therapy

Must not have

Evidence of advanced, age-related macular degeneration or intermediate macular degeneration as defined by Beckman classification

Clinically significant orthostatic hypotension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to week 12

Summary

This trial tests the safety and effects of IkT-148009, a daily pill, in people aged 30 to 80 with untreated Parkinson's disease. The drug aims to block an enzyme that may help manage symptoms. Participants will take the drug for a few months.

Who is the study for?

This trial is for people aged 30-80 with untreated Parkinson's Disease (PD) who meet specific medical criteria and can self-administer a drug daily with food. They must not need other PD treatments during the study, agree to birth control methods if of childbearing potential, and have no significant health issues that could affect participation.

What is being tested?

The trial tests IkT-148009's safety and how it affects the body compared to a placebo in managing Parkinson's symptoms. Participants will randomly receive either one of three doses of IkT-148009 or a placebo once daily for 12 weeks.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions to IkT-148009 which may include typical drug-related responses such as gastrointestinal discomfort, allergic reactions, or changes in mood or motor function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have Parkinson's disease with slow movements and uneven symptoms on both sides.

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I am not on any medication for Parkinson's disease.

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My Parkinson's disease is in the early or mid-stage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have advanced or intermediate age-related vision loss.

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I experience significant dizziness when standing up.

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I haven't taken Parkinson's disease medications or supplements for over 28 days.

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I am currently taking medication that strongly affects liver enzymes.

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I have abnormal blood vessel growth in my eye.

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I might have a rare form of Parkinson's disease.

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I have serious kidney problems.

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I have not had thoughts of harming myself in the past year.

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I am currently taking medication for psychosis, nausea, or ADHD.

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I've needed antipsychotics for severe hallucinations in the last year.

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I do not have skin conditions affecting sample collection.

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I have had or am expected to have surgery for Parkinson's disease during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to week 12 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Clinician Global Impression of Severity (CGI-S)

Complete Spontaneous Bowel Movement (CSBM)

Epworth Sleepiness Scale (ESS)

+9 more

Other study objectives

Phosphorylated alpha-synuclein in cerebrospinal fluid (CSF)

Phosphorylated alpha-synuclein in skin

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: 50mg IkT-148009Experimental Treatment1 Intervention

This arm will consist of thirty (30) patients on 50mg of active treatment.

Group II: 200mg IkT-148009Experimental Treatment1 Intervention

This arm will consist of thirty (30) patients on 200mg of active treatment.

Group III: 100mg IkT-148009Experimental Treatment1 Intervention

This arm will consist of thirty (30) patients on 100mg of active treatment.

Group IV: PlaceboPlacebo Group1 Intervention

This arm will consist of thirty (30) patients on placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IkT-148009

2021

Completed Phase 1

~110

0 / 15Eligibility criteria met

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

The most common treatments for Parkinson's Disease (PD) primarily aim to increase dopamine levels or mimic its action in the brain, addressing the dopamine deficiency that characterizes the disease. Levodopa, often combined with carbidopa, is converted to dopamine in the brain, providing symptomatic relief. Dopamine agonists, such as pramipexole and ropinirole, directly stimulate dopamine receptors. MAO-B inhibitors, like rasagiline, prevent the breakdown of dopamine, prolonging its action. Amantadine promotes dopamine release and has anticholinergic effects. These treatments are crucial for managing PD symptoms, improving motor function, and enhancing quality of life. The trial of IkT-148009, which evaluates a new treatment's safety and efficacy, is significant as it may offer additional therapeutic options or improvements over existing treatments.

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