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Can an inhaled levodopa ease Parkinson's OFF episodes? a study asks patients.

NCT ID NCT07797790

Symptom relief Sponsor: Merz Therapeutics GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study looks at how people with Parkinson's disease experience OFF episodes, when medication wears off and symptoms return. Researchers will follow up to 120 adults who are prescribed Inbrija, an inhaled levodopa, as part of their usual care. Over three months, they will track changes in mobility, daily functioning, and quality of life using patient questionnaires. The goal is to understand what influences patients' decisions to use Inbrija and whether it helps in real-world settings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Levodopa inhalation powder (Inbrija), an inhaled form of levodopa used to treat OFF episodes in Parkinson's disease
What this could lead to
If it works, this could show that Inbrija helps people with Parkinson's disease manage OFF episodes better, improving mobility and quality of life during daily routines.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results depend on patient reports and may not apply to everyone with Parkinson's disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population consists of adults with Parkinson's disease and a history of OFF episodes who have been prescribed Inbrija® (inhaled levodopa) as part of routine clinical practice. Participants will be recruited from neurology clinics and medical centers in Austria, Germany, and Sweden. The study includes both patients newly initiating Inbrija® and current Inbrija® users. Patients initiating Inbrija® will participate in the quantitative component and complete patient-reported outcome assessments over a 3-month period. A subset of current Inbrija® users will participate in qualitative interviews to describe their experiences of OFF episodes, treatment use, and the impact of Inbrija® on daily life and quality of life.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults aged 18 years or older. * Diagnosis of Parkinson's disease with a history of OFF episodes. * Able and willing to provide informed consent. For the Quantitative Component: • Physician decision to initiate Inbrija® for the treatment of OFF episodes in Parkinson's disease according to routine clinical practice prior to enrollment. For the Qualitative Component: * Current user of Inbrija® for OFF episodes in Parkinson's disease according to approved prescribing conditions. * At least 6 weeks of regular Inbrija® use (minimum 4 uses during the previous month). * Able to participate in a 60-minute interview using an internet-enabled device. Exclusion Criteria: For the Quantitative Component: * Previous use of Inbrija® before study enrollment. * Participation in an interventional Parkinson's disease clinical trial within 3 months prior to Inbrija® initiation. * Residence outside Austria, Germany, or Sweden. * Current use of an on-demand treatment for OFF episodes other than Inbrija®. For the Qualitative Component: * Participation in an interventional Parkinson's disease clinical trial within 3 months prior to enrollment. * Residence outside Austria or Germany. * Current use of an on-demand treatment for OFF episodes other than Inbrija®.

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Conditions

The condition(s) this trial relates to.

Fatigue Parkinson disease Social Stigma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Off episodes of Parkinson disease Parkinson disease (PD) Parkinson's disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    2 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Medizinischen Universität Graz

    Graz, 8010, Austria

  • Neurologisches Therapiezentrum Gmundnerberg GmbH

    Altmünster, 4813, Austria

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