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

NCT03655236 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: CLR_18_06
• Study Type: interventional
• Target: 513
• Locations: 6 countries
• Sites: 78

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

Conditions

Early Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• Change From Baseline to Week 40 in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Total Score.

  Part III: Motor examination: 18 items. Score range: 0-132, 32 and below is mild, 59 and above is severe.

  Week 40

• Number of Participants With Treatment-emergent Adverse Events

  Part 2 (Week 40 to 80)

Secondary Outcomes (6)

• Part 1: Change From Baseline to Week 40 in the Sum of the MDS-UPDRS Part II and Part III Total Scores and Part 2: Change From Week 40 to Week 76 in the MDS-UPDRS Part III Total Score.

  Part 1: Week 40 and Part 2: Week 76

• To Determine if K0706 Delays the Initiation of Symptomatic Medications in Participants

  Part 1: Week 40 and Part 2: Week 80 (Part 2 is applicable to the subjects who complete the EoT visit of part 1 (V11/Week 40) and who confirm their willingness to participate in part 2 of the study.

• Change in Health Related Quality of Life as Measured by the European Quality of Life Questionnaire 5 Level Version

  Week 40

• Change in Clinician Global Impression Severity

  Week 40

• Change in the Scales for Outcomes in Parkinson's Disease - Autonomic Questionnaire

  Week 40

Other Outcomes (5)

• Exploratory Outcome: Effect of K0706 on Dopamine Cell Health in Parkinson's Disease as Detected Via Dopamine Transporter Single Photon Emission Computed Tomography (DaT SPECT) Brain Imaging

  Week 40

• CSF K0706 Levels Progression or Target Engagement of K0706.

  Week 40

• Brain DaT SPECT - an Imaging Tool That is a Marker of Dopaminergic Cell Health.

  Week 40

Study Arms (3)

K0706, low dose

EXPERIMENTAL

Drug: K0706

K0706, high dose

EXPERIMENTAL

Drug: K0706

Placebo

PLACEBO COMPARATOR

Other: placebo

Interventions

K0706 DRUG

low dose, orally, once-daily

K0706, low dose

placebo OTHER

placebo, orally, once-daily

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged ≥ 50 years;
• Body mass index (BMI) greater than 18.5 kg/m2 and less than 45 kg/m2;
• 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;
• Projected to not required to start dopaminergic therapy within 9 months from Baseline;

You may not qualify if:

• 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;
• Prior use of dopaminergic therapy (e.g., levodopa, dopamine agonist, amantadine) for 30 or more days any time in the past;
• 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;
• A diagnosis of a medical condition that could interfere with interpretation of the MDS-UPDRS during the trial (e.g., musculoskeletal disorders);
• Contraindications to receiving an MRI;
• 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;
• 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;
• 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);
• Severe tremors as defined by a score of "severe" on any of the MDS-UPDRS Parts 2 or 3 tremor severity (not constancy) items;
• Montreal cognitive assessment score \< 25
• 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);
• History of hypersensitivity (e.g., bronchospasm, anaphylaxis, serious drug rash) to contents of the study drug or other tyrosine kinase inhibitors;
• 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)
• 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;
• 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

Sponsors & Collaborators

• Sun Pharma Advanced Research Company Limited: lead

Study Sites (78)

Xenoscience Inc. - 21st Century Neurology

Phoenix, Arizona, 85004, United States

Location

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

Little Rock, Arkansas, 72205, United States

Location

Keck Hospital of USC

Los Angeles, California, 90033, United States

Location

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

Santa Monica, California, 90404, United States

Location

Georgetown University Medical Center Department of Neurology, 7PHC

Washington D.C., District of Columbia, 20007, United States

Location

JEM Research Institute

Atlantis, Florida, 33462, United States

Location

Visionary Investigators Network

Aventura, Florida, 33180, United States

Location

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

Boca Raton, Florida, 33486, United States

Location

Neurology Associates PA

Maitland, Florida, 32751, United States

Location

Visionary Investigators Network

Miami, Florida, 33176, United States

Location

Medsol Clinical Research Center

Port Charlotte, Florida, 33952, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Kansas Medical Center (KUMC)

Kansas City, Kansas, 66160, United States

Location

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, 48322, United States

Location

Struthers Parkinson's Center -Park Nicollet

Golden Valley, Minnesota, 55427, United States

Location

Washington University (WUSTL) School of Medicine

St Louis, Missouri, 63110, United States

Location

Renown Regional Medical Center

Reno, Nevada, 89502, United States

Location

Dartmouth-Hitchcock Medical Center (DHMC) Neurology Research

Lebanon, New Hampshire, 03756, United States

Location

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

New Brunswick, New Jersey, 08901, United States

Location

Neurology Specialists of Monmouth County, PA

West Long Branch, New Jersey, 07764, United States

Location

Dent Neurologic Institute - Amherst

Amherst, New York, 14226, United States

Location

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

New York, New York, 10021, United States

Location

PMG Research of Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, 74136, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Advanced Neurology Epilepsy and Sleep Center

El Paso, Texas, 79912, United States

Location

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

Houston, Texas, 77030, United States

Location

Houston Methodist Neurological Institute

Houston, Texas, 77030, United States

Location

Central Texas Neurology Consultants (CTNC)

Round Rock, Texas, 78681, United States

Location

Evergreen Health

Kirkland, Washington, 98034, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Nyiro Gyula Hospital

Budapest, Buapest, 1135, Hungary

Location

Valeomed Diagnosztikai Kozpont

Esztergom, Komárom-Esztergom, 2500, Hungary

Location

Szent Borbála Kórház

Tatabánya, Komárom-Esztergom, 4032, Hungary

Location

Pest Megyei Flór Ferenc Kórház

Kistarcsa, Pest County, 2143, Hungary

Location

Nizam's Institute of Medical Sciences

Panjagutta, Hyderabad, 500082, India

Location

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

Mumbai, Maharashtra, 400016, India

Location

Jaslok Hospital and Research centre

Mumbai, Maharashtra, 400026, India

Location

Fortis Flt. Lt. Rajan Dhall Hospital

Vasant Kunj, New Delhi, 110070, India

Location

Medipoint Hospital

Aundh, Pune, 411007, India

Location

Lifepoint Multispeciality Hospital Pvt Ltd

Wakad, Pune, 411057, India

Location

Dayanand Medical College & Hospital, Research & Development Centre

Ludhiana, Punjab, 141001, India

Location

Citi Neuro Centre

Hyderabad, Telangana, 500 034, India

Location

Institute of Neurosciences Kolkata

Kolkata, West Bengal, 700017, India

Location

Bangur Institute of Neurosciences & Psychiatry (BINP)

Kolkata, India

Location

Sir Ganga Ram Hospital

New Delhi, 110060, India

Location

Deenanath Mangeshkar Hospital & Research Center (DMHRC)

Pune, 411004, India

Location

NZOZ Centrum Medyczne HCP

Poznan, Greater Poland Voivodeship, 61-485, Poland

Location

Nasz Lekarz Przychodnie Medyczne Ośrodek Badań Klinicznych

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

Location

Krakowska Akademia Neurologii

Krakow, Lesser Poland Voivodeship, 31-505, Poland

Location

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

Lublin, Lublin Voivodeship, 20-097, Poland

Location

ETG Lublin

Lublin, Lublin Voivodeship, 20-412, Poland

Location

RCMed Oddział w Sochaczewie

Sochaczew, Masovian Voivodeship, 96-500, Poland

Location

SINGUA Sp. Z o.o.

Warsaw, Masovian Voivodeship, 00-732, Poland

Location

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

Katowice, Silesian Voivodeship, 40-026, Poland

Location

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

Siemianowice Śląskie, Silesian Voivodeship, 41-100, Poland

Location

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

Warsaw, Poland

Location

SOMED CR

Lodz, Łódź Voivodeship, 90-368, Poland

Location

NEURES, s.r.o.

Krompachy, Spiska Nova Ves, 5342, Slovakia

Location

Medical Center Konzilium

Dubnica nad Váhom, Trenčín Region, 018 41, Slovakia

Location

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

Banská Bystrica, 974 04, Slovakia

Location

Plaza de Cruces, S/N

Barakaldo, Bilbao, 48903, Spain

Location

Policlínica Gipuzkoa

Donostia / San Sebastian, San Sebastián, 20014, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitari General de Catalunya

Barcelona, 08195, Spain

Location

Hospital Universitari de Bellvitge (IDIBELL)

Barcelona, 08907, Spain

Location

Hospital Universitari de Girona Doctor Josep Trueta

Girona, 17190, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital Universitario de la Princesa

Madrid, 28006, Spain

Location

Hospital Quiron Salud

Madrid, 28040, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, 28049, Spain

Location

Clínica Universidad de Navarra

Pamplona, 31008, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Universitario Dr. Peset

Valencia, 46017, Spain

Location

Related Publications (1)

• 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 Dec;28(12):1532-1563. doi: 10.1080/1028415X.2025.2531356. Epub 2025 Jul 18.

  PMID: 40680102 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Head, Clinical Development
• Organization: Sun Pharma Advanced Research Company Limited

clinical.trials@sparcmail.com

912266455645

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2018
• First Posted: August 31, 2018
• Study Start: February 18, 2019
• Primary Completion: April 8, 2024
• Study Completion: June 6, 2024
• Last Updated: July 25, 2025
• Results First Posted: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (34); IN (12); PL (11); ES (14); SL (3); HU (4)