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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.

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524296-23-01
Enrollment
58
Registered
2026-02-24
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinsons Disease

Brief summary

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

Detailed description

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”).

Interventions

DRUGFlexilev 5 mg/1
DRUG25 mg
DRUGdispergerbara tabletter för dosdispenser

Sponsors

Navamedic AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 25, 2026