What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease, such as levodopa, nonergot dopamine agonists (e.g., pramipexole, ropinirole), and MAO B inhibitors (e.g., rasagiline), are primarily symptomatic and can have various side effects. Levodopa may cause nausea, dizziness, headache, confusion, hallucinations, and orthostatic hypotension. Nonergot dopamine agonists can lead to edema, somnolence, constipation, dizziness, hallucinations, and nausea. MAO B inhibitors generally have milder side effects but can include insomnia and gastrointestinal issues. Cholinesterase inhibitors, used for cognitive impairment in Parkinson's Disease, may cause worsened tremor, nausea, and vomiting. These treatments do not modify the disease course but aim to manage symptoms.

What prior FDA approvals exist?

The FDA has approved several treatments for Parkinson's Disease, primarily focusing on symptom management rather than disease modification. Levodopa, often combined with carbidopa, remains the cornerstone of treatment for motor symptoms. Dopamine agonists like pramipexole, ropinirole, and the transdermal rotigotine patch are also widely used. MAO-B inhibitors such as selegiline and rasagiline offer modest benefits and are sometimes used in early stages. Amantadine is another option, particularly for managing tremor. While these treatments help manage symptoms, none have been definitively proven to alter the disease's progression. Research continues into potential neuroprotective agents, such as the investigational drug K0706, which targets Abl tyrosine kinase inhibition.

What other types of research exist?

Promising novel alternatives to K0706 for Parkinson's Disease patients include: 1) SK609, a dopamine D3 receptor agonist with norepinephrine transporter inhibition, which has shown improvement in cognitive and motor performance in PD models. 2) CGP 3466, which has demonstrated the ability to protect dopaminergic neurons and improve motor performance in PD models. 3) DJ-1 modulators like UCP0054278, which have shown neuroprotective effects in PD models. These agents offer potential neuroprotective or disease-modifying effects and could be considered for treatment in 2024.

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Tyrosine Kinase Inhibitor

K0706 for Parkinson's Disease

Verified Trial

Phase 2

Recruiting

Research Sponsored by Sun Pharma Advanced Research Company Limited

Eligibility Criteria Checklist

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

Must have

Is your BMI under 45 kg/m2?

Have you been diagnosed with Parkinson's disease in the past 3 years?

Must not have

Body mass index (BMI) greater than 18.5 kg/m2 and less than 45 kg/m2;

Males or females aged ≥ 50 years;

Timeline

Screening 42 days

Treatment Varies

Follow Up 4 weeks

Summary

This trial tests K0706, a new drug, in people with early Parkinson's Disease who are not on standard treatment. The drug aims to protect nerve cells and slow down the disease's progression.

Who is the study for?

This trial is for people who were diagnosed with Parkinson's disease within the last 3 years, have a BMI between 18.5 and 45 kg/m2, and are in the early stages of the disease (Hoehn and Yahr stage 2 or less). It's not open to those under age 50.

What is being tested?

The PROSEEK study is testing K0706, a new drug for early Parkinson's Disease. Participants will either receive K0706 or a placebo while not on any dopaminergic therapy. The first part determines if it works and is safe; an optional second part extends the study.

What are the potential side effects?

While specific side effects of K0706 aren't listed here, common ones in trials like this may include nausea, headache, dizziness, fatigue, or trouble sleeping. Placebo groups typically experience no active drug side effects.

Eligibility Criteria

Inclusion Criteria

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

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I was diagnosed with Parkinson's disease within the last 3 years.

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

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

Exclusion Criteria

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

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I am 50 years old or older.

Timeline

Screening ~ 42 days0 visits

Treatment ~ Varies

Follow Up ~ 4 weeks1 visit

Screening ~ 42 days

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 42 days for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from Baseline in the sum of MDS-UPDRS Parts 2 and 3

Secondary study objectives

Change in Clinician global impression severity

Change in health related quality of life as measured by the European quality of life questionnaire 5 level version

Change in the movement disorder society - unified Parkinson's disease rating scale

+3 more

Other study objectives

Blood K0706 levels

Brain DaT SPECT - an imaging tool that is a marker of dopaminergic cell health.

CSF K0706 levels progression or target engagement of K0706.

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: K0706, low doseExperimental Treatment1 Intervention

Group II: K0706, high doseExperimental Treatment1 Intervention

Group III: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

K0706

2017

Completed Phase 1

~110

0 / 6Eligibility 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) include dopaminergic therapies such as levodopa, dopamine agonists, MAO B inhibitors, and amantadine. These treatments primarily work by increasing dopamine levels or mimicking dopamine activity in the brain, which helps manage motor symptoms like tremors and rigidity. Some dopamine agonists also possess neuroprotective properties, potentially slowing disease progression. The trial K0706 explores an Abl tyrosine kinase inhibitor, aiming for a disease-modifying effect by targeting the underlying mechanisms of PD, which could offer long-term benefits beyond symptom management. This is crucial for PD patients as it opens the possibility of treatments that not only alleviate symptoms but also alter the disease course.

Advances in drug development for Parkinson's disease: present status.Dopamine receptor agonists for protection and repair in Parkinson's disease.