Status:
RECRUITING
SL-START - SubLingual Apomorphine Schemes of TitrAtion in Real-world Treatment
Lead Sponsor:
Bial - Portela C S.A.
Conditions:
Parkinson Disease
Eligibility:
All Genders
18+ years
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 determin...
Detailed Description
This study is a prospective, observational, real-word evidence study. It is a non-interventional study according to article 2(4) of the Clinical Trials Regulation. Visits are documented as they occur ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 27 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07145190
Start Date
August 27 2025
End Date
February 1 2028
Last Update
November 18 2025
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Charité - Universitätsmedizin Berlin - Sektion für Bewegungsstörungen und Neuromodulation
Berlin, Germany, 10117
2
Alexianer St. Joseph Berlin-Weißensee GmbH
Berlin, Germany, 13088
3
Praxis für Neurologie
Berlin, Germany, 15366
4
Katholisches Klinikum Bochum gGmbH, Universitätsklinikum St.Josef-Hospital, Klinik für Neurologie
Bochum, Germany, 44791