Overview
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.
Description
This is an open-label, observational, up to 12-week study evaluating patients' experience with Flexilev minitablets delivered through the OraFID dosing device and the Levilog reminder app.
Participants first complete an up-to-two-week run-in period, during which their current treatment is recorded and eligibility is assessed. Eligible patients then switch to Flexilev delivered by OraFID, are trained on the device and app, and receive an individualized dosing schedule based on their doctor's evaluation and prior treatment. Other daytime levodopa medications are stopped during the study, though slow-release levodopa is allowed at night; levodopa infusions are not permitted.
Within a week of starting treatment, patients receive a follow-up phone call to confirm or adjust the dosing schedule and check for any safety or device/app issues. This is followed by a 12-week treatment period, with phone check-ins at weeks 4 and 8 and an in-person visit at week 12. Dose adjustments are permitted throughout the study if needed.
Eligibility
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.
