OraFID dosing device, Levodopa/Carbidopa minitablets delivered via OraFID dosing device
OraFID dosing device, Levodopa/Carbidopa minitablets delivered via OraFID dosing device: Intervention Description
Levodopa 5 mg/carbidopa 1.25 mg dispersible minitablets, individually dosed in 5 mg levodopa increments (1-20 tablets per dose) via the OraFID mechanical dispensing device, with an optional Levilog app for dosing reminders and adherence tracking.
Study summary
Flexilev is a Parkinson's disease medicine made of small, dissolvable tablets containing low doses of levodopa and carbidopa, allowing doses to be adjusted in small, precise steps. OraFID is a new mechanical device that dispenses the exact number of tablets needed, with better than 99% accuracy, in amounts from 1 to 20 tablets. An optional companion app, Levilog, reminds patients when to take their dose and records how much medicine (tablets and milligrams) was taken.
This 12-week study will mainly assess how acceptable this treatment routine is and how well patients stick with it when using Flexilev with the OraFID device and app. It will also evaluate the treatment's efficacy, safety, and tolerability.
Eligibility
Sex
ALL
Min age
30 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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
* Have a minimum of 4 levodopa dosing occasions per day
* Stable medication within the last 4 weeks
* Be judged by the investigator to be eligible for Flexilev treatment.
* Subject (or caregiver, if applicable) demonstrates the understanding and correct use of the OraFID delivery system, as assessed by the investigator or designee.
* 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.
* Have a smartphone (either patient or caregiver)
* Ability to consent and comply with study specific procedures
* Able to read and write in Swedish
Exclusion Criteria:
* Inability of subject or caregiver to use the device
* 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.
* Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception.
Primary outcome measure(s)
Patient acceptability and satisfaction with the OraFID dosing device, self-reported via questionnaire — 12 weeks Assessed using a patient-reported questionnaire evaluating acceptability, ease of use, and satisfaction with the OraFID dosing device.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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