NCT03655236

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, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson's Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 513 (actual)
• Sponsor: Sun Pharma Advanced Research Company Limited · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Early Parkinson Disease

Interventions

Type	Name	Description
DRUG	K0706	low dose, orally, once-daily
DRUG	K0706	high dose, orally, once-daily
OTHER	placebo	placebo, orally, once-daily

Timeline

• Start date: 2019-02-18
• Primary completion: 2024-04-08
• Completion: 2024-06-06
• First posted: 2018-08-31
• Last updated: 2025-07-25
• Results posted: 2025-07-25

Locations

78 sites across 6 countries: United States, Hungary, India, Poland, Slovakia, Spain

Regulatory

• FDA-regulated drug study