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

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

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.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and consent
After agreeing to join the study, a consent form is signed and basic health information is recorded.
Step 2
Baseline monitoring
A wearable pkgs device is placed on the wrist during the night to record motor activity before any study medication is taken.
The data collected overnight provides a baseline measurement of motor severity.
Step 3
Assignment to study medication
The participant is randomly assigned to receive either inbrija (inhaled levodopa) or madopar quick (oral levodopa suspension) for the study period.
Step 4
Morning dose administration
Each morning, after an overnight fast, the assigned medication is taken once.
If assigned to inbrija, the dose is 33 mg of inhalation powder (equivalent to 66 mg per kilogram of body weight) delivered through an inhaler device.
If assigned to madopar quick, the dose is 125 mg of oral suspension (equivalent to 125 mg per kilogram of body weight) taken by mouth.
Step 5
Post‑dose monitoring
Immediately after the dose, the pkgs device continues to record motor activity for up to 120 minutes.
The device measures the time from the moment the dose is finished (time 0) to the first appearance of the "on" state, which indicates symptom improvement.
The participant also notes the moment they personally feel the "on" state.
Step 6
Patient‑reported outcomes
The participant completes a short questionnaire reporting the time to "on", ease of starting morning activities, perceived independence, and confidence.
Additional questions cover overall preference for the morning treatment and experience with its use.
Step 7
Standardized assessments
The participant completes several validated scales, including the unified parkinson’s disease rating scale part ii (mds‑updrs‑ii), the parkinson’s disease questionnaire (pdq‑8), and the non‑motor symptoms scale (mds‑nms‑q).
Step 8
Repetition for each study day
The same morning dose, monitoring, and questionnaire procedures are repeated on every scheduled study day according to the protocol.
Step 9
Study completion
After the final scheduled day, the wearable device is removed, any remaining study medication is returned, and a final set of questionnaires is completed.
The collected data are then used to compare the speed of symptom improvement between the inhaled and oral treatments.

Who can join the trial?

9 criteria

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 trial?

5 criteria

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.

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Verified
Rigshospitalet
Copenhagen, Denmark

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Investigated drugs

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.

What is already known about the treatment

Inbrija 33 mg inhalation powder
This medication is inhaled as a fine powder using a special inhaler, delivering levodopa directly to the lungs. It is an approved drug that is well‑studied for use in Parkinson’s disease and is listed in current medical references. The main purpose is to quickly relieve stiffness and slow movement that occurs in the early morning. It works by converting to dopamine in the brain, helping restore the chemical that is low in Parkinson’s patients, and is classified as a dopaminergic (levodopa) inhalation therapy.
Madopar Quick “125”
This product is taken by mouth as an oral suspension that contains levodopa together with benserazide. It is a long‑standing, approved treatment for Parkinson’s disease and is widely described in medical literature. It is used to improve movement and reduce tremor in people with Parkinson’s. The levodopa turns into dopamine in the brain while benserazide blocks an enzyme that would otherwise break levodopa before it reaches the brain, and the combination is classified as a levodopa/decarboxylase‑inhibitor therapy.

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.