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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Karolinska University Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Decision date (initial)

2026-06-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The primary objective of this trial is to evaluate the long-term safety and tolerability of montelukast in PD patients during extended treatment.

Secondary objectives 2

1. Assess clinical benefit over time and possible improvements in symptoms
2. Changes in inflammatory and neurodegenerative biomarkers

Conditions and MedDRA coding

Parkinson's Disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. The subject has given their written consent to participate in the trial.
2. Successful completion of the MONTPARK trial
3. In the opinion of the investigator, PD diagnosis still valid and subject remains eligible for treatment.
4. Female participants must be 1 year post-menopausal** or be willing and able to use highly effective contraception during the treatment and up to 3 months after the last dose of IMP. Oral, injected, or implanted hormonal contraceptive, intrauterine device, intrauterine hormone-releasing system, surgical sterilization, transdermal delivery, congenital sterility, vasectomised partner or sexual abstinence are considered acceptable forms of birth control.

Exclusion criteria 8

1. Already actively participating in another PD trial apart from MONTPARK.
2. Severe liver or renal disease.
3. HIV
4. Active Hepatitis B or C infection
5. Concurrent moderate-to-severe depression, defined as HADS ≥ 11.
6. Concurrent dementia, defined as MoCA < 20.
7. Pregnancy.
8. Any medical, psychiatric, or other condition which in the investigator’s opinion compromises the potential participant's ability to participate in the trial.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 7

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Karolinska University Hospital

Sponsor organisation

Karolinska University Hospital

Address

Eugeniavagen 3

City

Solna

Postcode

171 64

Country

Sweden

Scientific contact point

Organisation

Karolinska University Hospital

Contact name

Albert Hietala

Public contact point

Organisation

Karolinska University Hospital

Contact name

Albert Hietala

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications