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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

NCT03655236 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 513

Last updated 2025-07-25

Study results available
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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

Interventions

DRUG

K0706

low dose, orally, once-daily

DRUG

K0706

high dose, orally, once-daily

OTHER

placebo

placebo, orally, once-daily

Sponsors & Collaborators

  • Sun Pharma Advanced Research Company Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-18
Primary Completion
2024-04-08
Completion
2024-06-06
FDA Drug
Yes

Countries

  • United States
  • Hungary
  • India
  • Poland
  • Slovakia
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03655236 on ClinicalTrials.gov