A 12-Week Study of Flexilev With the OraFID Device and App in Parkinson's Patients

Phase 4RecruitingNCT07839793

Navamedic AB58 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Patient acceptability and satisfaction with the OraFID dosing device, self-reported via questionnaire

Assessed using a patient-reported questionnaire evaluating acceptability, ease of use, and satisfaction with the OraFID dosing device.

Time frame: 12 weeks

Secondary Outcomes

User opinion, usage, and ability to use the Levilog app

Self-reported via questionnaire on app usage and usability

Time frame: 12 weeks

Time required per dispensation/treatment with the OraFID device

Self-reported via questionnaire regarding the device

Time frame: 12 weeks

Compliance with the dosing schedule

Data obtained from the Levilog app and drug accountability records

Time frame: 12 weeks

Compliance with the app, i.e., willingness to register doses

Compliance and treatment data from Levilog app use, combined with self-reported data

Time frame: 12 weeks

Safety and acceptability of Flexilev delivered by OraFID and the app

Assessed via adverse event and serious adverse event reporting, and study withdrawals

Time frame: 12 weeks

Overall acceptability of Flexilev/OraFID/App

Self-reported via questionnaire regarding the device

Time frame: 12 weeks

User opinion of Flexilev treatment

Self-reported via questionnaire regarding treatment

Time frame: 12 weeks

Change in non-motor symptoms

Non-Motor Symptoms Questionnaire (NMSQ), self-reported