A multi-center, open label, longitudinal, observational, 12-week study of Flexilev treatment with the dosing device OraFID and accompanying digital app in Parkinson patients.

Condition studied

Parkinsons Disease

Investigational medicinal product(s)

Eligibility

Primary endpoint

Self-reported using questionnaire regarding the device (self-reported in Patients Own Registration in “Parkinsonregistret”)

Endpoint detail

Self-reported using questionnaire regarding the app (self-reported in Patients Own Registration in “Parkinsonregistret”), Self-reported using questionnaire regarding the device (self-reported in Patients Own Registration in “Parkinsonregistret”), Data obtained from the app Levilog and drug accountability records., Compliance with APP (Levilog) – and treatment data from use of APP (self-reported in Patients Own Registration in “Parkinsonregistret” + data obtained from the app), Safety reporting; adverse event and serious adverse events,withdrawals, Self-reported using questionnaire regarding the device (self-reported in Patients Own Registration in “Parkinsonregistret”), Self-reported using questionnaire regarding the device (self-reported in Patients Own Registration in “Parkinsonregistret”), NMSQ, Non-Motor Symptoms Questionnaire (NMSQ self-reported in Patients Own Registration in “Parkinsonregistret”)., HADS-D, Hospital Anxiety and Depression Scale, (HADS-D self-reported in Patients Own Registration in “Parkinsonregistret”)., PDQ-8, Parkinson's disease quality-of-life scale, and the EQ5D-5L (EuroQol) generic quality of life scale, together with the associated 0 to 100-point visual analog scale (VAS), (self-reported in Patients Own Registration in “Parkinsonregistret”)., OnOff - Self-reported OnOff Scale questionnaire (OnOff self-reported in Patients Own Registration in “Parkinsonregistret”)., OnOff - Self-reported OnOff Scale questionnaire (OnOff self-reported in Patients Own Registration in “Parkinsonregistret”)., PDSS-2 questionnaire (PDSS-2 self-reported in Patients Own Registration in “Parkinsonregistret”)., OnOff - Self-reported OnOff Scale questionnaire (OnOff self-reported in Patients Own Registration in “Parkinsonregistret”)., UPDRS, Unified Parkinson’s Disease Rating Scale (Physician reported in “Parkinsonregistret”), UPDRS, Unified Parkinson’s Disease Rating Scale (Physician reported in “Parkinsonregistret”), CISI-PD, Clinical Impression of Severity Index for Parkinson’s Disease (Physician reported in “Parkinsonregistret”), The PRO-PD, Patient-Reported Outcomes in Parkinson's Disease, (PRO-PD self-reported in Patients Own Registration in “Parkinsonregistret”).