SL-START - SubLingual Apomorphine Schemes of TitrAtion in Real-world Treatment
ConditionParkinson Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBial - Portela C S.A.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- SL-APO
Treatment groups
90 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov