Montelukast buccal film as disease modifying treatment in mild-moderate Parkinson’s disease (MONTPARK), a double-blind randomized placebo-controlled phase II trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504278-39-00

Enrollment

Registered

2023-10-30

Start date

2024-02-27

Completion date

Unknown

Last updated

2025-07-18

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 outcome is the measurement of motor symptoms using the MDS-UPDRS Part 3, collected in the OFF-medication state at baseline, 6-, 12-, 18- and 21-month visits. The primary endpoint will be the model adjusted estimate for change in motor symptom score from baseline to month 18 across each group

Detailed description

MDS-NMS, HADS, evaluated at baseline, 6-, 12-, 18-, and 21-months visit., Adverse events, evaluated continuously, LEDD score calculated at baseline and 18 months

Interventions

DRUGMontelukast film

DRUGMadopark 100 mg/25 mg tabletter

DRUGMontelukast 30 mg placebo buccal film

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary outcome is the measurement of motor symptoms using the MDS-UPDRS Part 3, collected in the OFF-medication state at baseline, 6-, 12-, 18- and 21-month visits. The primary endpoint will be the model adjusted estimate for change in motor symptom score from baseline to month 18 across each group	—

Secondary

Measure	Time frame
MDS-NMS, HADS, evaluated at baseline, 6-, 12-, 18-, and 21-months visit., Adverse events, evaluated continuously, LEDD score calculated at baseline and 18 months	—

Countries

Sweden

Outcome results

None listed

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