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Study on Montelukast for Slowing Parkinson's Disease Progression in Patients with Mild to Moderate Symptoms

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This clinical trial is focused on studying the effects of a medication called Montelukast on the progression of Parkinson's disease, which is a condition that affects movement and can cause symptoms like tremors and stiffness. The study aims to see if Montelukast can help slow down the progression of the disease in its early to moderate stages. Participants in the trial will be randomly assigned to receive either Montelukast or a placebo, which is a substance with no active medication, to compare the effects.

The trial will involve taking the medication in the form of a tablet, and it will be administered through the mouth. Participants will be monitored over a period of time to observe any changes in their symptoms. The study will include regular visits to assess the motor symptoms of Parkinson's disease and other related health aspects. These assessments will help determine if there is any improvement or change in the condition of the participants taking Montelukast compared to those taking the placebo.

Throughout the study, participants will continue their usual treatment with another medication called Madopark, which contains benserazide hydrochloride and levodopa. This medication is commonly used to manage symptoms of Parkinson's disease. The trial will last for several months, and the results will help researchers understand if Montelukast can be a beneficial treatment option for people with Parkinson's disease.

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
Joining the study
Upon joining the study, the patient must provide written consent to participate.
Eligibility includes a diagnosis of Parkinson's disease, age between 35 and 80, and ongoing levodopa treatment.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline measurements of motor symptoms using the MDS-UPDRS Part 3 scale.
This assessment occurs in the OFF-medication state.
Step 3
Medication administration
The patient receives either Montelukast buccal film or a placebo as part of the trial.
Montelukast is administered via buccal use, which involves placing the film inside the cheek.
Step 4
Ongoing treatment and monitoring
The patient continues their regular levodopa treatment alongside the trial medication.
Regular monitoring of motor symptoms and other health indicators occurs at 6, 12, 18, and 21 months.
Step 5
Evaluation of outcomes
Primary outcomes focus on changes in motor symptoms from baseline to 18 months.
Secondary outcomes include assessments of non-motor symptoms, anxiety, depression, and adverse events.
Step 6
Completion of the trial
The trial is expected to conclude by December 31, 2026.
Final assessments and data collection occur at the end of the trial period.

Who can join the trial?

9 criteria

The patient has given their written consent to participate in the trial.
The patient has a diagnosis of Parkinson's disease (PD).
Both males and females can participate.
The patient is at H&Y stage ≤ 2 in OFF. This means the patient is in the early stages of Parkinson's disease when not taking medication.
The patient is between 35 and 80 years of age.
The patient has had a clinical diagnosis of Parkinson's disease for less than 4 years.
The patient is currently receiving levodopa treatment, which is a common medication for Parkinson's disease.
The patient must be able to take the trial drug by themselves.
Female participants must be either 1 year post-menopausal or willing and able to use highly effective birth control during the treatment and for 3 months after the last dose of the trial medication. Acceptable forms of birth control include oral, injected, or implanted hormonal contraceptives, intrauterine devices, surgical sterilization, or having a vasectomized partner. A woman is considered of childbearing potential from the start of menstruation until menopause unless permanently sterile. Permanent sterilization includes procedures like hysterectomy or removal of ovaries. Menopause is defined as not having a menstrual period for 12 months without another medical reason.

Who cannot join the trial?

4 criteria

Patients who have a different condition than Parkinson's disease cannot participate.
Patients who are not in the early to moderate stages of Parkinson's disease cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who belong to a vulnerable population cannot participate.

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Verified sites

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

Verified
Region Skane Skanes Universitetssjukhus
Lund, Sweden
Verified
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Gothenburg, Sweden
Verified
Uppsala University Hospital
Uppsala, Sweden

Trial locations

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Investigated drugs

Montelukast is being studied as a potential treatment for slowing down the progression of mild to moderate Parkinson's disease. It is typically used to manage asthma and allergies by reducing inflammation in the airways. In this trial, researchers are investigating whether it can also have beneficial effects on the brain and help manage symptoms or slow the progression of Parkinson's disease.

What is already known about the treatment

Montelukast – Montelukast is administered as a buccal film, which is placed inside the mouth to dissolve and release the medication. It is currently being studied in clinical trials as a potential treatment for Parkinson's disease, specifically to see if it can slow disease progression in early to moderate stages. The main therapeutic indication being explored is its use in Parkinson's disease. Montelukast works by blocking leukotriene receptors, which are involved in inflammatory processes, potentially reducing inflammation in the brain. It is classified as a leukotriene receptor antagonist.

Investigated diseases

Parkinson's disease – Parkinson's disease is a progressive neurological disorder that primarily affects movement. It is characterized by tremors, stiffness, and difficulty with balance and coordination. As the disease progresses, individuals may experience slowness of movement and changes in speech and writing. The symptoms are due to the loss of dopamine-producing neurons in the brain. Over time, non-motor symptoms such as sleep disturbances, mood changes, and cognitive impairment may also develop. The progression of symptoms varies from person to person.