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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03655236
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : October 26, 2021
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

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. Patients can choose to participate in Part 2 of the study. The extension study was designed to evaluate the safety and efficacy of the study drug at 76 weeks.

Condition or disease Intervention/treatment Phase
Early Parkinson Disease Drug: K0706 Other: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson's Disease
Actual Study Start Date : February 18, 2019
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: K0706, low dose Drug: K0706
low dose, orally, once-daily

Experimental: K0706, high dose Drug: K0706
high dose, orally, once-daily

Placebo Comparator: Placebo Other: placebo
placebo, orally, once-daily

Primary Outcome Measures :
  1. Change from Baseline in the sum of MDS-UPDRS Parts 2 and 3 [ Time Frame: Week 40 ]

Secondary Outcome Measures :
  1. Change in the movement disorder society - unified Parkinson's disease rating scale [ Time Frame: Week 40 ]
  2. Time from Baseline to initiation of symptomatic medication [ Time Frame: Week 40 ]
  3. Change in health related quality of life as measured by the European quality of life questionnaire 5 level version [ Time Frame: Week 40 ]
  4. Change in Clinician global impression severity [ Time Frame: Week 40 ]
  5. Change in the scales for outcomes in Parkinson's disease - autonomic questionnaire [ Time Frame: Week 40 ]
  6. Level of K0706 [ Time Frame: Week 40 ]

Other Outcome Measures:
  1. 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 [ Time Frame: Week 40 ]
  2. CSF K0706 levels progression or target engagement of K0706. [ Time Frame: Week 40 ]
  3. Brain DaT SPECT - an imaging tool that is a marker of dopaminergic cell health. [ Time Frame: Week 40 ]
  4. Blood K0706 levels [ Time Frame: Week 40 ]
  5. Skin punch biopsy [ Time Frame: Week 40 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key inclusion Criteria:

  1. Subject has completed the 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 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.

Key exclusion Criteria:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03655236

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Contact: Head, Clinical development +1 (609) 720-5333

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Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
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Responsible Party: Sun Pharma Advanced Research Company Limited Identifier: NCT03655236    
Other Study ID Numbers: CLR_18_06
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: October 26, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases