drugset / Trial / NCT03655236

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

NCT03655236 ↗

Phase 2 Terminated 513 enrolled Sun Pharma Advanced Research Company Limited
RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start
2019-02-18
Primary completion
2024-04-08
Completion
2024-06-06

Outcome

Missed primary endpoint

Stopped: “Terminated based on study outcomes”

release “Part I of the PROSEEK study • Both low dose and high dose Vodobatinib arms did not meet the pre -specified primary endpoint” sparc.life ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Vodobatinib Small molecule — Oral

Indications