Carbidopa; Levodopa for Parkinson's disease

Inclusion criteria

• {"criterion_text":"- Male or female subjects, 30 years of age or older at the time of screening, with a diagnosis of idiopathic PD that is levodopa-responsive\n- Have a minimum of 4 levodopa dosing occasions per day\n- Stable medication within the last 4 weeks\n- Be judged by the investigator to be eligible for Flexilev treatment.\n- Subject (or caregiver, if applicable) demonstrates the understanding and correct use of the OraFID delivery system, as assessed by the investigator or designee.\n- Subject (or caretaker on behalf of the subject) is willing to use Patients Own Reporting module in the Parkinson registry and is willing to answer all questionnaires.\n- Have a smartphone (either patient or caregiver)\n- Ability to consent and comply with study specific procedures\n- Able to read and write in Swedish"}

Exclusion criteria

• {"criterion_text":"- Inability of subject or caregiver to use the device\n- Female patients who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical study and for three months later.\n- Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception"}

Primary endpoints

• {"endpoint_text":"- Self-reported using questionnaire regarding the device (self-reported in Patients Own Registration in “Parkinsonregistret”)","definition_or_measurement_approach":"Self-reported questionnaire responses entered by participants in the Patients Own Registration module of the Parkinson registry (Parkinsonregistret)."}

Secondary endpoints

• {"endpoint_text":"- Self-reported using questionnaire regarding the app (self-reported in Patients Own Registration in “Parkinsonregistret”)\n- Self-reported using questionnaire regarding the device (self-reported in Patients Own Registration in “Parkinsonregistret”)\n- Data obtained from the app Levilog and drug accountability records.\n- Compliance with APP (Levilog) – and treatment data from use of APP (self-reported in Patients Own Registration in “Parkinsonregistret” + data obtained from the app)\n- Safety reporting; adverse event and serious adverse events,withdrawals\n- Self-reported using questionnaire regarding the device (self-reported in Patients Own Registration in “Parkinsonregistret”)\n- Self-reported using questionnaire regarding the device (self-reported in Patients Own Registration in “Parkinsonregistret”)\n- NMSQ, Non-Motor Symptoms Questionnaire (NMSQ self-reported in Patients Own Registration in “Parkinsonregistret”).\n- HADS-D, Hospital Anxiety and Depression Scale, (HADS-D self-reported in Patients Own Registration in “Parkinsonregistret”).\n- 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”).\n- OnOff - Self-reported OnOff Scale questionnaire (OnOff self-reported in Patients Own Registration in “Parkinsonregistret”).\n- OnOff - Self-reported OnOff Scale questionnaire (OnOff self-reported in Patients Own Registration in “Parkinsonregistret”).\n- PDSS-2 questionnaire (PDSS-2 self-reported in Patients Own Registration in “Parkinsonregistret”).\n- OnOff - Self-reported OnOff Scale questionnaire (OnOff self-reported in Patients Own Registration in “Parkinsonregistret”).\n- UPDRS, Unified Parkinson’s Disease Rating Scale (Physician reported in “Parkinsonregistret”)\n- UPDRS, Unified Parkinson’s Disease Rating Scale (Physician reported in “Parkinsonregistret”)\n- CISI-PD, Clinical Impression of Severity Index for Parkinson’s Disease (Physician reported in “Parkinsonregistret”)\n- The PRO-PD, Patient-Reported Outcomes in Parkinson's Disease, (PRO-PD self-reported in Patients Own Registration in “Parkinsonregistret”).","definition_or_measurement_approach":"All secondary endpoints are measured primarily via self-reported questionnaires entered in Patients Own Registration in the Parkinson registry and/or data from the Levilog app and drug accountability records. Several physician-reported scales (UPDRS, CISI-PD) are recorded in the Parkinson registry; others (NMSQ, HADS-D, PDQ-8, EQ-5D-5L, PDSS-2, OnOff, PRO-PD) are self-reported via the registry."}

Sweden

Earliest CTIS Part Ii Submission Date

17-12-2025

Latest Decision Or Authorization Date

22-04-2026

Processing Time Days

126

Number Of Sites

6

Number Of Participants

58

Primary sponsor

Full Name

Navamedic AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden