Long-Term Safety and Clinical Effects of Nilotinib in Parkinson's Disease.

ABSTRACT:

Background

Nilotinib is US Food and Drug Administration-approved for leukemia, and this open-label study investigated the safety, tolerability, and potential clinical effects of nilotinib in medically optimized patients with Parkinson's disease.

Objectives

Safety and tolerability were the primary objectives, and clinical outcomes were exploratory.

Methods

A total of 63 patients completed a 15-month phase 2, double-blind, placebo-controlled study and were rerandomized 1:1 into an open-label study of nilotinib 150 mg versus 300 mg for 12 months.

Results

Nilotinib was safe and tolerated, and no adverse effects seemed to be related to the drug, and no differences in adverse events were observed between groups. Exploratory clinical outcomes showed that nilotinib 300

SUBMITTER: Pagan FL 

PROVIDER: S-EPMC8048914 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature