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New study aims to perfect dosing of Parkinson's rescue drug

NCT ID NCT07145190

Symptom relief Sponsor: Bial - Portela C S.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Aug 12, 2026 · Updated 3 times

Summary

This study is testing SL-APO (Kynmobi), a fast-acting film placed under the tongue, to treat OFF episodes in people with Parkinson's disease. OFF episodes are times when Parkinson's symptoms return between medication doses. The study will enroll 90 adults and observe how doctors adjust the dose in real-world settings, aiming to find the most effective and safe dose for each person. The goal is to improve patient satisfaction and treatment success.

What this could mean

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

Active substance
SL-APO (apomorphine sublingual film, brand name Kynmobi)
What this could lead to
If successful, this study could help doctors find the most effective and tolerable dose of SL-APO for quickly relieving Parkinson's OFF episodes, improving patient satisfaction and daily function.
What could go wrong
This is an early real-world study with only 90 participants, not a large controlled trial. Results may not apply to all patients, and side effects like nausea or dizziness are possible.

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 90 people

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

Started

Aug 2025

Expected to finish

Feb 2028

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

Adult patients experiencing OFF symptoms which cannot be managed by oral anti-PD medication. For clarification, patients who have previously been exposed to apomorphine can also be included in the study.

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: * The patient is ≥ 18 years of age. * The patient has a clinical diagnosis of idiopathic Parkinson's disease. * The patient will initiate SL-APO for the treatment of OFF episodes according to the SmPC. * The patient is not currently on titration or maintenance dose for SL-APO. * The patient has provided written informed consent to participate in this study. Exclusion Criteria: * The patient is participating in a clinical trial with an investigational drug. * The patient has presented with dementia or evidence of cognitive decline as determined by the investigator. * The patient has a history of psychotic disorder. * The patient presents any other contraindication according to the SL-APO SmPC.

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

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

Parkinson 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

    12 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

  • Alexianer St. Joseph Berlin-Weißensee GmbH

    SUSPENDED

    Berlin, 13088, Germany

  • Charité - Universitätsmedizin Berlin - Sektion für Bewegungsstörungen und Neuromodulation

    RECRUITING

    Berlin, 10117, Germany

  • Die Nerven Docs

    RECRUITING

    Siegen, 57072, Germany

  • Katholisches Klinikum Bochum gGmbH, Universitätsklinikum St.Josef-Hospital, Klinik für Neurologie

    NOT_YET_RECRUITING

    Bochum, 44791, Germany

  • Klinik am Tharandter Wald

    RECRUITING

    Hetzdorf, 09633, Germany

  • Klinik für Neurologie und Neurologische Frührehabilitation

    RECRUITING

    Osnabrück, 49076, Germany

  • Neurologie am Funkerberg

    RECRUITING

    Wusterhausen, 15711, Germany

  • Neurologische Klinik Sorpesee

    RECRUITING

    Sundern, 59846, Germany

  • Praxis für Neurologie

    RECRUITING

    Berlin, 15366, Germany

  • Praxis für Neurologie und Geriatrie

    RECRUITING

    Ulm, 89073, Germany

  • Praxis für Neurologie und Psychiatrie

    RECRUITING

    Fulda, 36037, Germany

    Contact Email: •••••@•••••

  • UNIVERSITÄTSKLINIKUM FREIBURG - Neurozentrum Klinik für Neurologie und Neurophysiologie im Neurozentrum

    RECRUITING

    Freiburg im Breisgau, D-79106, Germany

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