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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2026-525906-37-00

Enrollment

Registered

2026-06-03

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Brief summary

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.

Detailed description

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)

Interventions

DRUGMONTELUKAST

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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)	—

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 4, 2026