Study of inhaled levodopa versus oral levodopa plus benserazide for early‑morning OFF in Parkinson’s disease patients

3 1 1 1

What is this study about?

The trial focuses on Parkinson’s disease, a brain condition that causes shaking, stiffness and difficulty beginning movements. The investigational product is Inbrija, an inhalation powder that delivers the medication levodopa directly to the lungs for rapid absorption. It is compared with an oral liquid form called Madopar Quick, which also contains levodopa together with a helper substance that improves its effect. The purpose of the study is to see whether the inhaled form can produce a faster return to the “on” state, when symptoms improve, after the first morning dose.

Participants will take the assigned dose in the early morning after an overnight fast and will be observed for up to two hours. Their movement will be recorded with a wearable device that measures motor activity, referred to as a PKG monitor. The time from taking the dose until the first sign that the medication is working (the “on” state) will be recorded, as will the time the participants themselves notice improvement. After a short break, participants will receive the other medication and undergo the same observations. No additional invasive procedures are required.

In addition to the primary timing measure, the study will collect information on how participants feel about each treatment, their ability to start morning activities, and overall quality of life. Scores that assess daily movement difficulties and non‑motor symptoms will be gathered, and the wearable monitor will also track periods of slow movement (bradykinesia) and any involuntary movements. Sleep patterns may be evaluated through the same device, and all data are used to compare the two ways of delivering levodopa.

Who Can Join the Study?

  • Have been diagnosed with idiopathic Parkinson’s disease, which means Parkinson’s disease not caused by another known condition.
  • Be at least 18 years old.
  • Have a history of early morning off (EMO), meaning Parkinson’s symptoms get worse when you first wake up and are not quickly controlled in the morning.
  • Be willing and able to stop using any fast‑acting morning levodopa medicines (such as Madopar® Quick or Inbrija®) during the study’s initial run‑in and wash‑out periods (a short time when you stop the medicines so the study can start cleanly).
  • Be able to take the study medication on your own, or with only a little help, right after you wake up.
  • Have been on a steady Parkinson’s medication plan for at least four weeks before joining the study.
  • Be able and willing to wear the PKG‑Watch, a small device that continuously records your movements during the whole study.
  • Be able and willing to use inhaled levodopa (Inbrija®), a medication you breathe in.
  • Currently take levodopa together with a peripheral decarboxylase inhibitor (such as carbidopa or benserazide), which helps the medicine work better.

Who Cannot Join the Study?

  • Using advanced Parkinson’s disease (PD) therapies such as deep brain stimulation (a surgery that puts tiny wires in the brain) or continuous infusion therapies (medication delivered constantly through a pump) during the study period.
  • Having cognitive impairment (memory or thinking problems) or a psychiatric illness (mental health condition) that makes it difficult to follow the study rules, as judged by the doctor.
  • Having a serious long‑term lung disease or abnormal results on a breathing test called spirometry, which could make inhaled medication unsafe.
  • Being pregnant or breastfeeding.
  • Having a known allergy or intolerance to any of the inactive ingredients (excipients) in the inhaled medicine, such as L‑leucine or the components benserazide and carbidopa.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Rigshospitalet Copenhagen Denmark

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

Trial status

Country Status Recruitment Start
Denmark Denmark
Not yet recruiting
01.08.2026

Trial locations

Inbrija is a medication that comes as a powder you inhale through the mouth. It contains levodopa, which is a drug that helps replace a chemical that is low in the brains of people with Parkinson’s disease. In this study, Inbrija is being tested to see if it can make patients feel “ON” (when their symptoms improve) more quickly in the early morning compared with the usual oral medicine.

Madopar Quick is a fast‑acting oral liquid that you swallow. It contains levodopa together with benserazide, a substance that helps the levodopa work better by preventing it from being broken down too soon. In the trial, Madopar Quick is used as the standard treatment to compare against Inbrija, showing how quickly each medicine can bring patients out of the “off” state in the morning.

Investigated diseases:

Parkinson’s disease – Parkinson’s disease is a brain disorder that mainly affects movement. It starts with mild signs such as a slight tremor or stiffness in one hand and slowly spreads to other parts of the body. Over time, people may find it harder to start or control movements, and walking can become unsteady. Muscle rigidity and slower movements often become more noticeable as the condition advances. Some people also develop changes in mood, sleep, or thinking that tend to increase with disease progression.

Trial ID:
2026-526465-18-00
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • A study using [11C]ORM-13070 to examine the effects of aging and Parkinson’s disease on specific brain receptors.

    Recruiting

    2 1 1
    France
  • A Study Testing SUL-238 in Patients with Early, Untreated Parkinson’s Disease to Assess Effects on Brain Energy Metabolism

    Recruiting

    2 1
    Investigated diseases:
    The Netherlands