An Observational Study of the Efficacy and Usability of OraFID Dispensing Device and Digital Application for Carbidopa and Levodopa Administration in Parkinson's Disease Patients

The primary objective is the evaluation of a new dispensing device, the OraFID, in patients with Parkinson's disease. Secondary objectives include:

• Assessment of user opinion, usability, and adherence regarding the device and the accompanying digital application.
• Evaluation of safety, acceptability, and treatment compliance.
• Measurement of motor outcomes, including on-off fluctuations, daily normalized off time, and on time without troublesome dyskinesia, utilizing the Unified Parkinson's Disease Rating Scale (UPDRS).
• Evaluation of non-motor symptoms, including depression, sleep, and overall disease severity.
• Assessment of quality of life and patient-reported outcomes via the PDQ-8, EQ-5D-5L, and PRO-PD scales.

The sponsor did not provide the total number of participants. The study population consists of male and female patients diagnosed with Parkinson's disease. Eligible individuals are 30 years of age or older at the time of screening and must present with idiopathic Parkinson's disease that is levodopa-responsive. Participants are required to have a minimum of four levodopa dosing occasions per day and must have maintained stable medication levels for at least the previous four weeks. Inclusion requires the subject or a caregiver to demonstrate proficiency in using the OraFID delivery system and possess a smartphone. Additionally, participants must be able to read and write in Swedish, comply with study-specific procedures, and utilize a patient-reported outcome module within a registry.

This multi-center, open-label, longitudinal, observational study is designed to evaluate the use of the OraFID dosing device and a digital application during Parkinson's disease treatment with Flexilev. The study follows a 12-week duration. The methodology involves a screening process to assess eligibility based on specific clinical criteria, including a diagnosis of idiopathic Parkinson's disease that is levodopa-responsive. Participants are required to utilize the Patients Own Reporting module within a registry and possess a smartphone for data collection. The research focuses on self-reported outcomes via questionnaires and data obtained through the Levilog application. Clinical assessments may include the Unified Parkinson’s Disease Rating Scale and various quality-of-life measures. The study procedures involve regular monitoring of compliance, safety reporting, and adverse events. Participation concludes upon the completion of the scheduled 12-week observation period.

The experimental treatment consists of Flexilev, which is administered as orally ingested dispersion tablets for use with a dosing device. The medication contains a combination of levodopa and carbidopa, a decarboxylase inhibitor, in a strength of 5 mg/1.25 mg. The total daily dose is 1000 mg.

The efficacy assessment for patients with Parkinson's disease focuses on the evaluation of a new dispensing device and an accompanying digital application. The primary endpoint is defined as a self-reported evaluation of the device, collected via a questionnaire through the Patients Own Registration in the Parkinsonregistret.

Secondary endpoints include:

• Self-reported questionnaire data regarding the application and the device.
• Data obtained from the Levilog application and drug accountability records.
• Compliance metrics for the application and treatment data derived from both application usage and patient registration.
• The Non-Motor Symptoms Questionnaire (NMSQ).
• The Hospital Anxiety and Depression Scale (HADS-D).
• Quality of life assessments using the Parkinson's disease quality-of-life scale (PDQ-8), the EuroQol generic quality of life scale (EQ5D-5L), and an associated visual analog scale (VAS).
• The OnOff Scale questionnaire.
• The PDSS-2 questionnaire.
• The Unified Parkinson’s Disease Rating Scale (UPDRS) reported by a physician.
• The Clinical Impression of Severity Index for Parkinson’s Disease (CISI-PD) reported by a physician.
• Patient-Reported Outcomes in Parkinson's Disease (PRO-PD).