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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Region Skane Skanes Universitetssjukhus Lund Sweden
Region Stockholm – SLSO Stockholm Sweden
Uqmpnep Umentetwpv Hwuyjxxm Uppsala Sweden
Spjlbviicgb Udairytabs Hcfablinyznxade Gytpycfyqijvqqcnh Gothenburg Sweden

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Sweden Sweden
Recruiting
01.09.2023

Trial locations

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.

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.

Trial ID:
2023-504278-39-00
Trial Phase:
Therapeutic exploratory (Phase II)

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