Montelukast as disease modifying treatment in mild-moderate Parkinson’s disease, an open-label, phase II extension trial (MONTPARK_OLE)

Condition studied

Parkinson's Disease

Investigational medicinal product(s)

Eligibility

Primary endpoint

The primary endpoint is the rate and severity of AE including abnormal laboratory values. The rate will be compared to active and placebo arm of the original MONTPARK trial. AE will be documented at each visit but also continuously as needed.

Endpoint detail

MDS-UPDRS Part 3, MDS-UPDRS parts 1, 2 and 4, Montreal Cognitive Assessment (MoCA), The Clinical Impression of Severity Index for Parkinson's Disease (CISI-PD), The Parkinson’s Disease Questionnaire (PDQ)-8, Hospital Anxiety and Depression Scale (HAD), The Non-Motor Symptoms Questionnaire (NMSQ)