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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
Awards & highlights

Study Summary

This trial is testing a new drug for Parkinson's Disease. It will compare it to a placebo to see if it is effective, safe, and tolerated. There is also an extension study for subjects who complete the first part of the trial.

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.Check my eligibility
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.See study design
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
Select...
I was diagnosed with Parkinson's disease within the last 3 years.
Select...
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:
Select...
I am 50 years old or older.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in the sum of MDS-UPDRS Parts 2 and 3
Secondary outcome measures
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 outcome measures
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

Find a Location

Logistics

Travel, including flights, are covered

Your expenses for travel tickets for this trial will be reimbursed.

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Sun Pharma Advanced Research Company LimitedLead Sponsor
32 Previous Clinical Trials
4,083 Total Patients Enrolled

Media Library

K0706 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03655236 — Phase 2
Parkinson's Disease Research Study Groups: K0706, high dose, K0706, low dose, Placebo
Parkinson's Disease Clinical Trial 2023: K0706 Highlights & Side Effects. Trial Name: NCT03655236 — Phase 2
K0706 (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03655236 — Phase 2
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT03655236 — Phase 2

Frequently Asked Questions

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

Could you explain the risks associated with K0706?

"K0706's safety is rated at a 2 because, although there is some data backing its safety, none of it supports efficacy."

Answered by AI

Are there any current openings for individuals who wish to participate in this clinical trial?

"Yes, this trial is still looking for volunteers. The original posting was on February 18th, 2019 with the most recent update being on October 29th, 20202."

Answered by AI

Is this trial being run in more than one place?

"There are 37 different medical facilities where patients can take part in this trial, such as Pacific Movement Disorders Center Pacific Neuroscience Institute Providence Saint John's Health Center in Santa Monica, California; USF Parkinson's disease and Movement Disorder Center in Tampa, Florida; and Emory University Hospital - Movement Disorders in Atlanta, Georgia."

Answered by AI

How many people are being asked to participate in this research project?

"In order to conduct this clinical trial, 504 individuals that fit the inclusion criteria will be needed. The sponsor, Sun Pharma Advanced Research Company Limited, will manage the study from various locations like Pacific Movement Disorders Center Pacific Neuroscience Institute Providence Saint John's Health Center in Santa Monica, California and USF Parkinson's disease and Movement Disorders Center in Tampa, Georgia."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Washington
Other
North Carolina
How old are they?
18 - 65
65+
What site did they apply to?
Weill Cornell Medicine Department of Neurology Parkinson's Disease and Movement Disorders Institute
Evergreen Health
Other
PMG Research of Winston-Salem
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I am interested in details for this study.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
PROSEEK: A Phase 2 Study In Early Parkinson's Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase Inhibition Using K0706
2019. "PROSEEK: A Phase 2 Study In Early Parkinson's Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase Inhibition Using K0706". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03655236.
All > Parkinson
~82 spots leftby Apr 2025
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