PROSEEK: A Phase 2 Study In Early Parkinson's Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase Inhibition Using K0706

NCT ID: NCT03655236

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 513 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-18
• Study Completion Date: 2024-06-06

Brief Summary

This study consists of 2 parts. Part 1 of the study is conducted to evaluate the efficacy, safety, and tolerability of two doses of K0706 compared to placebo in subjects with early Parkinson's Disease who are not receiving dopaminergic therapy. Part 2 is an optional long term extension study for subjects who have completed week 40 of Part 1

Detailed Description

This study is designed to assess the ability of K0706 to slow the progression of PD. Preclinical animal model data have already demonstrated that K0706 has neuroprotective activity, but further development will require human clinical experience.

This study will also allow determination of safety and tolerability of K0706 over many months in subjects with PD.

Conditions

Early Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

K0706, low dose

Group Type: EXPERIMENTAL

K0706

Intervention Type: DRUG

low dose, orally, once-daily

K0706, high dose

Group Type: EXPERIMENTAL

K0706

Intervention Type: DRUG

high dose, orally, once-daily

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

placebo, orally, once-daily

Interventions

K0706

low dose, orally, once-daily

Intervention Type: DRUG

K0706

high dose, orally, once-daily

Intervention Type: DRUG

placebo

placebo, orally, once-daily

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Males or females aged ≥ 50 years;

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

3. Diagnosed with "Clinically Probable PD" according to the MDS clinical diagnostic criteria, with documented diagnosis of PD per treating physician's records within three years of the Screening visit. Disease severity according to modified Hoehn & Yahr stage ≤ 2;

4. Projected to not required to start dopaminergic therapy within 9 months from Baseline;

1. Subject has completed part 1 of the study.

2. Subject projected not to need dopaminergic treatment except for treatment with Monoamine Oxidase B (MAOB) inhibitors. MAOB inhibitors will be allowed if the patient was already taking the same during part 1 of the study.

3. Subject has received K0706/placebo, as appropriate, within 4 weeks prior to end of part 1 of the study.

4. Male subjects enrolled in the study should not father a child and are advised to prevent the passage of semen to their sexual partner during intercourse using an effective method, as judged by the Investigator, for the duration of the study and for 3 months after the last dose of study drug

Exclusion Criteria

1. Current, or within 60 days of Screening, use of any prescription, investigational, or over the counter medication for the symptomatic treatment of PD or to slow the progression of PD. Treatment with Monoamine Oxidase B (MAOB) inhibitors will be allowed if the dose is stable for at least 30 days prior to Screening and subjects agree to remain on it for the duration of the study;

2. Prior use of dopaminergic therapy (e.g., levodopa, dopamine agonist, amantadine) for 30 or more days any time in the past;

3. A diagnosis of a significant central or peripheral nervous system disease affecting the subject's cognition or motor function at any time, such as another neurodegenerative disorder, multiple sclerosis or stroke. This does not include transient neurological deficits such as transient ischemic attacks or migraine aura;

4. A diagnosis of a medical condition that could interfere with interpretation of the MDS-UPDRS during the trial (e.g., musculoskeletal disorders);

5. Contraindications to receiving an MRI;

6. Contraindications to receiving a DaT SPECT scan (e.g., hypersensitivity to the active substance, any of the excipients, or iodine) if a new DaT SPECT scan is required for the study;

7. Most recent DaT SPECT scan not compatible with PD (i.e., Scans Without Evidence of Dopaminergic Deficit [SWEDD]) based on a central reading by a study physician;

8. MRI of the brain performed after onset of PD suggestive of secondary Parkinsonism (e.g., subdural hematoma, normal pressure hydrocephalus, or infarcts of the basal ganglia);

9. Severe tremors as defined by a score of "severe" on any of the MDS-UPDRS Parts 2 or 3 tremor severity (not constancy) items;

10. Montreal cognitive assessment score < 25

11. History of any surgery on the brain itself including deep brain stimulation for PD (note this does not include surgeries on the skull that do not affect the brain, e.g., small meningioma removal);

12. History of hypersensitivity (e.g., bronchospasm, anaphylaxis, serious drug rash) to contents of the study drug or other tyrosine kinase inhibitors;

13. Recent use of medications that can cause Parkinsonism and suspicion of the investigator that it could have worsened the subject's Parkinsonism. This includes neuroleptics (e.g., olanzapine, risperidone, haloperidol), some anti-nausea medications (e.g., prochlorperazine, metoclopramide) and others (e.g., flunarizine, methyldopa)

14. Use of medications that affect the dopaminergic system within 60 days of Screening. This includes stimulants (e.g., methylphenidate, amphetamine derivatives, modafinil) and Monoamine Oxidase A (MAOA) inhibitors (e.g., phenelzine, and tranylcypromine). Note that antidepressants are acceptable as long as the subject has remained on them at a stable dose for over 60 days prior to Screening and plans to remain on them through the study;

15. Any malignant disease (other than basal cell carcinoma of the skin) with evidence of disease within the past 5 years and with the potential for recurrence

Part 2:

1. Clinically significant or unstable psychiatric or medical condition, vital sign, or laboratory abnormality that in the opinion of the investigator interferes with participation in the study

2. Any condition that in the opinion of the Investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for the subject.

3. Subject has any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g., renal failure, heart failure, hypertension, liver disease, diabetes, or anemia) that, in the opinion of the Investigator, could cause continued treatment to be detrimental to the subject

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Pharma Advanced Research Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xenoscience Inc. - 21st Century Neurology

Phoenix, Arizona, United States

University of Arkansas for Medical Sciences (UAMS) - Movement Disorders Clinic

Little Rock, Arkansas, United States

Keck Hospital of USC

Los Angeles, California, United States

Pacific Movement Disorders Center Pacific Neuroscience Institute Providence Saint John's Health Center

Santa Monica, California, United States

Georgetown University Medical Center Department of Neurology, 7PHC

Washington D.C., District of Columbia, United States

JEM Research Institute

Atlantis, Florida, United States

Visionary Investigators Network

Aventura, Florida, United States

Parkinson's Disease and Movement Disorders Center of Boca Raton, Inc.

Boca Raton, Florida, United States

Neurology Associates PA

Maitland, Florida, United States

Visionary Investigators Network

Miami, Florida, United States

Medsol Clinical Research Center

Port Charlotte, Florida, United States

Emory University

Atlanta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Kansas Medical Center (KUMC)

Kansas City, Kansas, United States

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, United States

Struthers Parkinson's Center -Park Nicollet

Golden Valley, Minnesota, United States

Washington University (WUSTL) School of Medicine

St Louis, Missouri, United States

Renown Regional Medical Center

Reno, Nevada, United States

Dartmouth-Hitchcock Medical Center (DHMC) Neurology Research

Lebanon, New Hampshire, United States

Robert Wood Johnson Medical School Department of Neurology, Clinical Academic Building (CAB)

New Brunswick, New Jersey, United States

Neurology Specialists of Monmouth County, PA

West Long Branch, New Jersey, United States

Dent Neurologic Institute - Amherst

Amherst, New York, United States

Weill Cornell Medicine Department of Neurology Parkinson's Disease and Movement Disorders Institute

New York, New York, United States

PMG Research of Winston-Salem

Winston-Salem, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, United States

Oregon Health and Science University

Portland, Oregon, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Advanced Neurology Epilepsy and Sleep Center

El Paso, Texas, United States

Baylor College of Medicine (BCM)- Parkinson's Disease Center and Movement Disorders Clinic (PDCMDC)

Houston, Texas, United States

Houston Methodist Neurological Institute

Houston, Texas, United States

Central Texas Neurology Consultants (CTNC)

Round Rock, Texas, United States

Evergreen Health

Kirkland, Washington, United States

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Nyiro Gyula Hospital

Budapest, Buapest, Hungary

Valeomed Diagnosztikai Kozpont

Esztergom, Komárom-Esztergom, Hungary

Szent Borbála Kórház

Tatabánya, Komárom-Esztergom, Hungary

Pest Megyei Flór Ferenc Kórház

Kistarcsa, Pest County, Hungary

Nizam's Institute of Medical Sciences

Panjagutta, Hyderabad, India

P.D. Hinduja National Hospital and Medical Care Research Centre

Mumbai, Maharashtra, India

Jaslok Hospital and Research centre

Mumbai, Maharashtra, India

Fortis Flt. Lt. Rajan Dhall Hospital

Vasant Kunj, New Delhi, India

Medipoint Hospital

Aundh, Pune, India

Lifepoint Multispeciality Hospital Pvt Ltd

Wākad, Pune, India

Dayanand Medical College & Hospital, Research & Development Centre

Ludhiana, Punjab, India

Citi Neuro Centre

Hyderabad, Telangana, India

Institute of Neurosciences Kolkata

Kolkata, West Bengal, India

Bangur Institute of Neurosciences & Psychiatry (BINP)

Kolkata, , India

Sir Ganga Ram Hospital

New Delhi, , India

Deenanath Mangeshkar Hospital & Research Center (DMHRC)

Pune, , India

NZOZ Centrum Medyczne HCP

Poznan, Greater Poland Voivodeship, Poland

Nasz Lekarz Przychodnie Medyczne Ośrodek Badań Klinicznych

Torun, Kuyavian-Pomeranian Voivodeship, Poland

Krakowska Akademia Neurologii

Krakow, Lesser Poland Voivodeship, Poland

NZOZ Neuromed M. i M. Nastaj Sp. P.

Lublin, Lublin Voivodeship, Poland

ETG Lublin

Lublin, Lublin Voivodeship, Poland

RCMed Oddział w Sochaczewie

Sochaczew, Masovian Voivodeship, Poland

SINGUA Sp. Z o.o.

Warsaw, Masovian Voivodeship, Poland

C.M. Silmedic Sp. z o.o.

Katowice, Silesian Voivodeship, Poland

Neuro-Care - Sp. z o.o. Sp. Komandytowa Ul. Szpitalna 6

Siemianowice Śląskie, Silesian Voivodeship, Poland

Mazowiecki Szpital Brodnowski w Warszawie Sp. z o.o.

Warsaw, , Poland

SOMED CR

Lodz, Łódź Voivodeship, Poland

NEURES, s.r.o.

Krompachy, Spiska Nova Ves, Slovakia

Medical Center Konzilium

Dubnica nad Váhom, Trenčín Region, Slovakia

MUDr. Beata Dupejova, neurologicka ambulancia s.r.o

Banská Bystrica, , Slovakia

Plaza de Cruces, S/N

Barakaldo, Bilbao, Spain

Policlínica Gipuzkoa

Donostia / San Sebastian, San Sebastián, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Hospital Universitari General de Catalunya

Barcelona, , Spain

Hospital Universitari de Bellvitge (IDIBELL)

Barcelona, , Spain

Hospital Universitari de Girona Doctor Josep Trueta

Girona, , Spain

Hospital Universitario Virgen de las Nieves

Granada, , Spain

Hospital Universitario de la Princesa

Madrid, , Spain

Hospital Quiron Salud

Madrid, , Spain

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Clínica Universidad de Navarra

Pamplona, , Spain

Hospital Universitario Virgen del Rocío

Seville, , Spain

Hospital Universitario Dr. Peset

Valencia, , Spain

Countries

United States; Hungary; India; Poland; Slovakia; Spain

References

Joshi D, Kulkarni M, Parekh P, Shah S, Greig NH, Acharya S. Targeting protein kinases in Parkinson's disease: the emerging role of phytoconstituents. Nutr Neurosci. 2025 Jul 18:1-32. doi: 10.1080/1028415X.2025.2531356. Online ahead of print.

Reference Type: DERIVED

PMID: 40680102 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CLR_18_06

Identifier Type: -

Identifier Source: org_study_id