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

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]

Trial duration

27 Feb 2024 → ongoing

Decision date (initial)

2023-10-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Vetenskapsrådet

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

The primary objective of the trial is to examine the effect of Montelukast on disease progression in early to moderate PD

Secondary objectives 3

1. To examine the effect on non-motor symptoms of Montelukast in early to moderate PD
2. To examine whether participants on Montelukast treatment have more frequent adverse events, changes in vital signs, and/or clinical laboratory values than participants in the placebo group
3. To examine change in dopaminergic treatment as measured in LEDD between baseline and last visit.

Conditions and MedDRA coding

Parkinson's disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. The patient has given their written consent to participate in the trial
2. Diagnosis of PD
3. Males or Females
4. H&Y stage ≤ 2 in OFF
5. ≥35 and ≤80 years of age
6. Clinical diagnosis < 4 years
7. Ongoing levodopa treatment
8. Ability to self-administer the trial drug
9. Female subjects 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. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post- menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.

Exclusion criteria 13

1. Previous or concurrent depression requiring hospitalisation
2. Pregnancy
3. HIV
4. Active Hepatitis B or C infection
5. Any medical, psychiatric, or other condition which in the investigator’s opinion compromises the potential participant's ability to participate in the trial
6. Atypical or other causes of parkinsonism
7. Prior intra-cerebral surgical intervention
8. Already actively participating in a PD trial
9. Exposure to Montelukast in the last six months
10. Severe liver or renal disease
11. Concurrent moderate-to-severe depression, defined as MADRS > 20
12. Concurrent dementia, defined as MMSE < 22
13. Active oral mucosa inflammation

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 3

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

Investigational products

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

Test 1

Placebo 1

Auxiliary 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

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 6 files

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

Application history

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