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Montelukast Sodium for disease-modifying treatment in patients with mild‑moderate Parkinson’s disease: open‑label phase II extension study

Verified siteRegistered drug

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on Parkinson's Disease, a brain condition that causes shaking, stiffness, and slow movement. Participants will receive the oral medication montelukast, which is being tested to see if it can change the course of the disease. The main goal of the trial is to evaluate the long‑term safety and tolerability of the drug, meaning how safe it is over time and how well people can continue to take it without problems.

After completing an earlier trial, participants may stay in the study and keep taking the medicine each day. They will visit the clinic at regular intervals where doctors will check their health, run blood tests, and ask them to fill out several questionnaires. These include a movement assessment called MDS-UPDRS, a short thinking test known as MoCA, a severity rating questionnaire (CISI-PD), a quality‑of‑life survey (PDQ-8), an anxiety and depression screen (HAD), and a questionnaire about other symptoms (NMSQ). Any side effects or abnormal lab results will be recorded, and the safety information will be compared with data from the earlier study’s active and placebo groups.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial enrollment visit
After joining the study, you attend an enrollment visit where study staff confirm eligibility and obtain written consent.
The visit includes collection of basic health information and review of current medications.
Step 2
Baseline assessments
A series of assessments are performed to document the starting condition.
These include a physical examination, laboratory tests, and questionnaires such as the mds-updrs, moCA, and pdq-8 to evaluate motor function, cognition, and quality of life.
Step 3
Start of study medication
You begin taking montelukast 60 mg by mouth once each day.
montelukast is the active substance; the dose is expressed in milligrams, which is a standard unit of weight for medicines.
The medication is taken continuously for the entire extension period of the trial.
Step 4
Regular follow‑up visits
You return to the study site at scheduled intervals, typically every three months.
During each visit, safety labs are drawn, and the same questionnaires used at baseline are repeated to track changes.
Any new symptoms or side effects are recorded.
Step 5
Continuous safety monitoring
Outside of scheduled visits, you are asked to report any adverse event (unwanted medical occurrence) as soon as it is noticed.
The study team may contact you to obtain additional information if needed.
Step 6
Final study visit
At the end of the trial period, you attend a final visit that repeats the baseline assessments.
The purpose is to evaluate long‑term safety, tolerability, and any changes in disease measures.

Who can join the trial?

6 criteria

You must have signed a written form giving your permission to join the study, which is called written consent.
You need to have finished the earlier MONTPARK trial successfully.
The doctor must think that your diagnosis of Parkinson's disease is still correct and that you are suitable for the treatment.
If you are a woman, you must be at least one year after the end of your menstrual periods (post‑menopausal) or be willing and able to use a very reliable method of birth control during the study and for three months after the last dose.
Acceptable birth‑control methods include: pills, shots, or implants that contain hormones (hormonal contraceptives); a device placed in the uterus (intrauterine device) or a hormone‑releasing system placed in the uterus; permanent procedures such as surgery that prevents pregnancy (surgical sterilization); skin patches that release medication (transdermal delivery); natural inability to have children (congenital sterility); a partner who has had a vasectomy (vasectomised partner); or choosing not to have sexual activity (sexual abstinence).
Both men and women can take part in the study.

Who cannot join the trial?

8 criteria

Already taking part in another Parkinson's Disease study (any study other than this one).
Having severe liver (organ that cleans the blood) or kidney (organ that removes waste) disease.
Being infected with HIV (human immunodeficiency virus).
Having an active infection with Hepatitis B or Hepatitis C (viruses that affect the liver).
Having moderate‑to‑severe depression (a serious mood problem) as shown by a score of 11 or higher on the HADS questionnaire.
Having dementia (significant memory and thinking problems) as shown by a score lower than 20 on the MoCA test.
Being pregnant.
Having any other medical, mental health, or health condition that the doctor believes would make it difficult to take part in the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
Gothenburg, Sweden
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Region Skane Skanes Universitetssjukhus
Lund, Sweden
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Uppsala University Hospital
Uppsala, Sweden

Trial locations

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Investigated drugs

Montelukast is a medicine that is usually taken by mouth. In this study it is being tested to see if it can help slow down the progression of mild to moderate Parkinson’s disease. Researchers are giving it to patients for a longer period to check how safe it is and how well people can tolerate it over time. The goal is to find out whether montelukast can be a useful treatment that changes the course of the disease, not just relieve symptoms.

Montelukast Sodium

What is already known about the treatment

Montelukast - Montelukast is taken as a 60 mg oral tablet that patients swallow with water. It is an approved medicine for asthma and allergic rhinitis and is well described in medical literature, but its use in Parkinson’s disease is still experimental. The drug is mainly used to reduce inflammation in the airways, and in this trial it is being tested to see if it can slow the progression of Parkinson’s symptoms. It works by blocking leukotriene receptors, which stops certain chemicals from causing swelling, and it belongs to the class of leukotriene‑receptor antagonists.

Investigated diseases

Parkinson's Disease - Parkinson's disease is a nervous system disorder that mainly affects movement. It starts when brain cells that produce dopamine begin to die, reducing the chemical that helps control muscles. Early signs often include a slight tremor or shaking in one hand. As the condition progresses, stiffness, slower movements, and balance problems become more noticeable. Over time, people may also experience changes in mood, sleep, and thinking abilities.