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The trial investigates the use of sublingual apomorphine (SL-APO) for treating OFF episodes in patients with Parkinson's disease. It aims to gather real-world data on how SL-APO is used and adjusted, focusing on determining individual doses after initial dose adjustments. The study seeks to understand how these dosing practices affect patient satisfaction, treatment adherence, and the balance between effectiveness and safety, potentially helping to improve dosing strategies. Participants start treatment with a 10 mg dose of SL-APO taken during OFF episodes. If this dose is tolerated and provides an adequate motor response within 30 minutes, it becomes the maintenance dose. Otherwise, the dose is increased in 5 mg steps up to a maximum of 30 mg per dose and up to five doses per day, with at least 2 hours between doses. Dose adjustments and responses are monitored both in clinic and at home, with follow-up visits at 3 and 6 months. Patients keep diaries recording their dosing and response from the second dose until the end of the study. After consenting, patients undergo a baseline visit where the initial 10 mg dose is tested. Dose titration continues at home if needed, with follow-up calls or visits to confirm the optimal dose. Patients maintain diaries throughout titration and the maintenance phase, with daily entries for at least the first week and weekly entries thereafter. The study ends at 6 months, with investigators deciding if patients should continue the maintenance dose afterward. The primary outcome is identifying the most frequently used dose after dose adjustments within six months.

Age: 18Years +All Genders
12 locations
Uckerland Clinical Trials | DecenTrialz