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Early Parkinson DiseasePhase 2NCT03655236

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

A Phase 2 study testing K0706 in people with Early Parkinson Disease, run by Sun Pharma Advanced Research Company Limited at 78 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Early Parkinson Disease
What is being tested?
K0706
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
513 participants
Where
78 sitesin 6 countries
Study dates
18 Feb 2019to 6 Jun 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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;
Show all 19Show fewer
  • 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
  • Part 2:
  • 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
  • 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.
  • 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

Trial locations and contacts

78 sites in 6 countries.

78 sites in 6 countries

United States34 sites

  • Dent Neurologic Institute - Amherst

    Amherst, New York, 14226

  • Emory University

    Atlanta, Georgia, 30329

  • JEM Research Institute

    Atlantis, Florida, 33462

  • Visionary Investigators Network

    Aventura, Florida, 33180

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

    Boca Raton, Florida, 33486

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Advanced Neurology Epilepsy and Sleep Center

    El Paso, Texas, 79912

  • Struthers Parkinson's Center -Park Nicollet

    Golden Valley, Minnesota, 55427

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

    Houston, Texas, 77030

  • Houston Methodist Neurological Institute

    Houston, Texas, 77030

  • University of Kansas Medical Center (KUMC)

    Kansas City, Kansas, 66160

  • Evergreen Health

    Kirkland, Washington, 98034

  • Dartmouth-Hitchcock Medical Center (DHMC) Neurology Research

    Lebanon, New Hampshire, 03756

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

    Little Rock, Arkansas, 72205

  • Keck Hospital of USC

    Los Angeles, California, 90033

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Neurology Associates PA

    Maitland, Florida, 32751

  • Visionary Investigators Network

    Miami, Florida, 33176

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

    New Brunswick, New Jersey, 08901

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

    New York, New York, 10021

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Xenoscience Inc. - 21st Century Neurology

    Phoenix, Arizona, 85004

  • Medsol Clinical Research Center

    Port Charlotte, Florida, 33952

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • Central Texas Neurology Consultants (CTNC)

    Round Rock, Texas, 78681

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

    Santa Monica, California, 90404

  • Washington University (WUSTL) School of Medicine

    St Louis, Missouri, 63110

  • The Movement Disorder Clinic of Oklahoma

    Tulsa, Oklahoma, 74136

  • Georgetown University Medical Center Department of Neurology, 7PHC

    Washington D.C., District of Columbia, 20007

  • Henry Ford West Bloomfield Hospital

    West Bloomfield, Michigan, 48322

  • Neurology Specialists of Monmouth County, PA

    West Long Branch, New Jersey, 07764

  • PMG Research of Winston-Salem

    Winston-Salem, North Carolina, 27103

Other trials in United States

Spain14 sites

  • Plaza de Cruces, S/N

    Barakaldo, Bilbao, 48903

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitari General de Catalunya

    Barcelona, 08195

  • Hospital Universitari de Bellvitge (IDIBELL)

    Barcelona, 08907

  • Policlínica Gipuzkoa

    Donostia / San Sebastian, San Sebastián, 20014

  • Hospital Universitari de Girona Doctor Josep Trueta

    Girona, 17190

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014

  • Hospital Universitario de la Princesa

    Madrid, 28006

  • Hospital Quiron Salud

    Madrid, 28040

  • Hospital Universitario Ramón y Cajal

    Madrid, 28049

  • Clínica Universidad de Navarra

    Pamplona, 31008

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Hospital Universitario Dr. Peset

    Valencia, 46017

Other trials in Spain

India12 sites

  • Medipoint Hospital

    Aundh, Pune, 411007

  • Citi Neuro Centre

    Hyderabad, Telangana, 500 034

  • Institute of Neurosciences Kolkata

    Kolkata, West Bengal, 700017

  • Bangur Institute of Neurosciences & Psychiatry (BINP)

    Kolkata

  • Dayanand Medical College & Hospital, Research & Development Centre

    Ludhiana, Punjab, 141001

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

    Mumbai, Maharashtra, 400016

  • Jaslok Hospital and Research centre

    Mumbai, Maharashtra, 400026

  • Sir Ganga Ram Hospital

    New Delhi, 110060

  • Nizam's Institute of Medical Sciences

    Panjagutta, Hyderabad, 500082

  • Deenanath Mangeshkar Hospital & Research Center (DMHRC)

    Pune, 411004

  • Fortis Flt. Lt. Rajan Dhall Hospital

    Vasant Kunj, New Delhi, 110070

  • Lifepoint Multispeciality Hospital Pvt Ltd

    Wākad, Pune, 411057

Other trials in India

Poland11 sites

  • C.M. Silmedic Sp. z o.o.

    Katowice, Silesian Voivodeship, 40-026

  • Krakowska Akademia Neurologii

    Krakow, Lesser Poland Voivodeship, 31-505

  • SOMED CR

    Lodz, Łódź Voivodeship, 90-368

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

    Lublin, Lublin Voivodeship, 20-097

  • ETG Lublin

    Lublin, Lublin Voivodeship, 20-412

  • NZOZ Centrum Medyczne HCP

    Poznan, Greater Poland Voivodeship, 61-485

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

    Siemianowice Śląskie, Silesian Voivodeship, 41-100

  • RCMed Oddział w Sochaczewie

    Sochaczew, Masovian Voivodeship, 96-500

  • Nasz Lekarz Przychodnie Medyczne Ośrodek Badań Klinicznych

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • SINGUA Sp. Z o.o.

    Warsaw, Masovian Voivodeship, 00-732

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

    Warsaw

Other trials in Poland

Hungary4 sites

  • Nyiro Gyula Hospital

    Budapest, Buapest, 1135

  • Valeomed Diagnosztikai Kozpont

    Esztergom, Komárom-Esztergom, 2500

  • Pest Megyei Flór Ferenc Kórház

    Kistarcsa, Pest County, 2143

  • Szent Borbála Kórház

    Tatabánya, Komárom-Esztergom, 4032

Other trials in Hungary

Slovakia3 sites

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

    Banská Bystrica, 974 04

  • Medical Center Konzilium

    Dubnica nad Váhom, Trenčín Region, 018 41

  • NEURES, s.r.o.

    Krompachy, Spiska Nova Ves, 5342

Other trials in Slovakia

About this study

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson's Disease

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

Read the 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.

Being tested
K0706, placebo
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • K0706Drug

    low dose, orally, once-daily

  • K0706Drug

    high dose, orally, once-daily

  • placeboOther

    placebo, orally, once-daily

Study groups in NCT03655236
Study groupRoleWhat they receive
K0706, low doseExperimentalNot described
Receives: Drug: K0706
K0706, high doseExperimentalNot described
Receives: Drug: K0706
PlaceboPlacebo comparatorNot described
Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 40

  2. Number of Participants With Treatment-emergent Adverse Events

    Measured: Part 2 (Week 40 to 80)

Secondary outcomes (6)

  1. 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.

    The Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II assesses the motor aspects of experiences of daily living based on patient self-report. It comprises 13 items, each rated on a 5-point scale ranging from 0 (normal) to 4 (severe impairment). The total score for Part II ranges from 0 to 52, calculated as the sum of the individual item scores.

    The MDS-UPDRS Part III assesses the motor symptoms of Parkinson's disease. This part consists of 18 items, which are assessed across various body regions, resulting in 33 individual scores. Each item is rated on a 5-point scale from 0 (normal) to 4 (severe impairment), with higher scores indicating greater motor dysfunction. The total score for Part III ranges from 0 to 132, which is the sum of the individual item scores.

    The sum of the MDS-UPDRS Part II and Part III total scores ranges from 0 to 184, with high scores indicating greater clinical impairment.

    Measured: Part 1: Week 40 and Part 2: Week 76

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

    Measured: 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.

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

    Health-Related quality of life (HRQoL) will be measured using the European Quality of Life Questionnaire 5 level version (EQ-5D-5L). This scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine.

    Measured: Week 40

  4. Change in Clinician Global Impression Severity

    The Clinician Global Impression Severity (CGIS) is a tool used to measure overall disease severity, assessed as follows:

    1. Normal
    2. Borderline
    3. Mild
    4. Moderate
    5. Marked
    6. Severe
    7. Among the Most Extremely Ill Patient

    Measured: Week 40

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

    The Scales for Outcome in Parkinson's disease - Autonomic (SCOPA-AUT) sum score is a sum of rating scores over 23 items. The SCOPA-AUT sum score ranges from 0 to 69. A higher score means a more severe autonomic dysfunction (i.e., a worse outcome). For each of the 23 items, the score ranges from 0 to 3. The rating scale is the follows:

    0= Never experiencing the symptom;

    1. Sometimes experiencing the symptom;
    2. Regularly experiencing the symptom;
    3. Often experiencing the symptom

    Measured: Week 40

  6. Serum Concentration Level of K0706

    Plasma pharmacokinetic (PK) samples were collected Week 28, per the Schedule of Assessment of the study protocol. There was no PK samples collected after Week 28 per the study protocol.

    Measured: Week 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2018
  2. Study start18 Feb 2019
  3. Primary completion8 Apr 2024
  4. Study completion6 Jun 2024

Why it stopped: Terminated based on study outcomes

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
513 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03655236
Sponsor's protocol ID
CLR_18_06
Status last verified
Jul 2025
First submitted
18 Aug 2018
Last updated
25 Jul 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40680102

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing K0706 in people with Early Parkinson Disease, run by Sun Pharma Advanced Research Company Limited at 78 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, Spain, India, Poland, Hungary and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 40 in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Total Score. (time frame: Week 40). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03655236, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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