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

Phase 2

Terminated

Conditions: Early Parkinson Disease

Interventions: Drug: K0706
Other: placebo

Registration Number: NCT03655236

Lead Sponsor: 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

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 513

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
K0706, low dose	K0706	-
K0706, high dose	K0706	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 40 in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Total Score.	Week 40	Part III: Motor examination: 18 items. Score range: 0-132, 32 and below is mild, 59 and above is severe.
Number of Participants With Treatment-emergent Adverse Events	Part 2 (Week 40 to 80)

Secondary Outcome Measures

Name	Time	Method
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	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.
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	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.
Change in Clinician Global Impression Severity	Week 40	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
Change in the Scales for Outcomes in Parkinson's Disease - Autonomic Questionnaire	Week 40	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
Serum Concentration Level of K0706	Week 28	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.

Trial Locations

Locations (77): 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, District of Columbia, United States
JEM Research Institute
🇺🇸
Atlantis, Florida, United States
Visionary Investigators Network
🇺🇸
Miami, 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
Medsol Clinical Research Center
🇺🇸
Port Charlotte, Florida, United States
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Xenoscience Inc. - 21st Century Neurology
🇺🇸Phoenix, Arizona, United States