NCT07145190 SL-START - SubLingual Apomorphine Schemes of TitrAtion in Real-world Treatment
| NCT ID | NCT07145190 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bial - Portela C S.A. |
| Condition | Parkinson Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-08-27 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 90 participants in total. It began in 2025-08-27 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Jan Kassubek, Prof Dr med
PRINCIPAL INVESTIGATOR
Praxis für Neurologie und Geriatrie (Ulm)
Frequently Asked Questions
Who can join the NCT07145190 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07145190 currently recruiting?
Yes, NCT07145190 is actively recruiting participants. Contact the research team at clinical.trials@bial.com for enrollment information.
Where is the NCT07145190 trial being conducted?
This trial is being conducted at Berlin, Germany, Berlin, Germany, Berlin, Germany, Bochum, Germany and 8 additional locations.
Who is sponsoring the NCT07145190 clinical trial?
NCT07145190 is sponsored by Bial - Portela C S.A.. The principal investigator is Jan Kassubek, Prof Dr med at Praxis für Neurologie und Geriatrie (Ulm). The trial plans to enroll 90 participants.
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