Nilotinib Effects on Safety, Tolerability, and Potential Biomarkers in Parkinson Disease: A Phase 2 Randomized Clinical Trial.

ABSTRACT:

Importance

This study evaluated nilotinib safety and its effects on biomarkers as a potential disease-modifying drug in Parkinson disease.

Objectives

To assess nilotinib effects on safety and pharmacokinetics and measure the change in exploratory biomarkers in patients with moderately severe Parkinson disease.

Design, setting, and participants

This was a single-center, phase 2, randomized, double-blind, placebo-controlled trial with 300 patients approached in clinic; of these, 200 declined to participate, 100 were screened, 25 were excluded, and 75 were randomized 1:1:1 into placebo; nilotinib, 150-mg; or nilotinib, 300-mg groups. Recruitment started on May 17, 2017, and ended April 28, 2018, and follow-up ended August 10, 2019. Parkinson disease was confirmed accordi

SUBMITTER: Pagan FL 

PROVIDER: S-EPMC6990742 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature