SL-APO in the Treatment of Patients With Parkinson's Disease: a Real-world Evidence Study to Identify Titration and Usage Schemes - SL-START

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Germany
Alexianer St. Joseph Berlin-Weißensee GmbH
NOT_YET_RECRUITING
Berlin
Charité - Universitätsmedizin Berlin - Sektion für Bewegungsstörungen und Neuromodulation
NOT_YET_RECRUITING
Berlin
Praxis für Neurologie
RECRUITING
Berlin
Katholisches Klinikum Bochum gGmbH, Universitätsklinikum St.Josef-Hospital, Klinik für Neurologie
NOT_YET_RECRUITING
Bochum
UNIVERSITÄTSKLINIKUM FREIBURG - Neurozentrum Klinik für Neurologie und Neurophysiologie im Neurozentrum
NOT_YET_RECRUITING
Freiburg Im Breisgau
Praxis für Neurologie und Psychiatrie
NOT_YET_RECRUITING
Fulda
Klinik am Tharandter Wald
NOT_YET_RECRUITING
Hetzdorf
Klinik für Neurologie und Neurologische Frührehabilitation
NOT_YET_RECRUITING
Osnabrück
Die Nerven Docs
NOT_YET_RECRUITING
Siegen
Neurologische Klinik Sorpesee
NOT_YET_RECRUITING
Sundern
Praxis für Neurologie und Geriatrie
NOT_YET_RECRUITING
Ulm
Neurologie am Funkerberg
RECRUITING
Wusterhausen
Contact Information
Primary
Ruben Arnelas
clinical.trials@bial.com
+351229866100
Time Frame
Start Date: 2025-08-27
Estimated Completion Date: 2028-02
Participants
Target number of participants: 90
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Bial - Portela C S.A.

This content was sourced from clinicaltrials.gov