SL-START - SubLingual Apomorphine Schemes of TitrAtion in Real-world Treatment

NCT07145190 | Recruiting

• 1 other identifier: BIA-KYNMB-401
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 12

Brief Summary

The purpose of the study is to generate real-world evidence data for the on-demand treatment with SL-APO, focusing on understanding its usage and titration practices including individual dose determination after dose-adjustment to ultimately understand their influence in patient satisfaction, treatment persistence, and the balance between effectiveness and safety. The data may help optimize titration approaches to better meet the patient's needs.

Conditions

Parkinson Disease

Keywords

Kynmobi; SL-APO

Outcome Measures

Primary Outcomes (1)

• Identify the most frequent dose used after dose-adjustment

  The purpose of the study is to generate real-world evidence data for the on-demand treatment with SLAPO, focusing on understanding its usage and titration practices including individual dose determination after dose-adjustment to ultimately understand their influence in patient satisfaction, treatment persistence, and the balance between effectiveness and safety. The data may help optimize titration approaches to better meet the patient's needs.

  Up to 6 months

Study Arms (1)

SL-START

SL-APO is available as a treatment initiation pack, containing two sublingual films of each strength (total of 30 films). The treatment initiation pack is usually used at the start of treatment to find an effective and tolerable dose. Depending on the patient response, not all doses in this pack may be needed.

Drug: SL-APO

Interventions

SL-APO DRUG

Patients should start with a dose of 10 mg SL-APO. Dose initiation should occur when the patient is having an OFF episode. If the patient tolerates the 10 mg dose, and responds adequately (meaning satisfactory motor response within 30 minutes), the maintenance dose should be 10 mg. If the dose is tolerated but the response is insufficient, continue to titrate in 5 mg increments when the patient is having an OFF episode and assess response until an effective and tolerable dose is achieved, up to a maximum of 30 mg per dose and up to five times a day. If an "ON" response is achieved and if clinically warranted, consider the need to further up-titrate as tolerated to achieve a better "ON" response. The minimal interval between doses is 2 hours, with no more than one dose of SL-APO per OFF episode.

Also known as: Kynmobi

SL-START

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (12)

Charité - Universitätsmedizin Berlin - Sektion für Bewegungsstörungen und Neuromodulation

Berlin, 10117, Germany

RECRUITING

Alexianer St. Joseph Berlin-Weißensee GmbH

Berlin, 13088, Germany

NOT YET RECRUITING

Praxis für Neurologie

Berlin, 15366, Germany

RECRUITING

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

Bochum, 44791, Germany

NOT YET RECRUITING

UNIVERSITÄTSKLINIKUM FREIBURG - Neurozentrum Klinik für Neurologie und Neurophysiologie im Neurozentrum

Freiburg im Breisgau, D-79106, Germany

NOT YET RECRUITING

Praxis für Neurologie und Psychiatrie

Fulda, 36037, Germany

RECRUITING

Klinik am Tharandter Wald

Hetzdorf, 09633, Germany

RECRUITING

Klinik für Neurologie und Neurologische Frührehabilitation

Osnabrück, 49076, Germany

NOT YET RECRUITING

Die Nerven Docs

Siegen, 57072, Germany

RECRUITING

Neurologische Klinik Sorpesee

Sundern, 59846, Germany

RECRUITING

Praxis für Neurologie und Geriatrie

Ulm, 89073, Germany

RECRUITING

Neurologie am Funkerberg

Wusterhausen, 15711, Germany

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Jan Kassubek, Prof Dr med

  Praxis für Neurologie und Geriatrie (Ulm)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruben Arnelas

CONTACT

+351229866100; clinical.trials@bial.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 28, 2025
• Study Start: August 27, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (12)