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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-09-24
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
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.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
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.
Eligibility
primary outcomes
Time frame: 12 weeks
Assessed using a patient-reported questionnaire evaluating acceptability, ease of use, and satisfaction with the OraFID dosing device.
secondary outcomes
Time frame: 12 weeks
Self-reported via questionnaire on app usage and usability
Time frame: 12 weeks
Self-reported via questionnaire regarding the device
Time frame: 12 weeks
Data obtained from the Levilog app and drug accountability records
Time frame: 12 weeks
Compliance and treatment data from Levilog app use, combined with self-reported data
Time frame: 12 weeks
Assessed via adverse event and serious adverse event reporting, and study withdrawals
Time frame: 12 weeks
Self-reported via questionnaire regarding the device
Time frame: 12 weeks
Self-reported via questionnaire regarding treatment
Time frame: Baseline to week 12
Non-Motor Symptoms Questionnaire (NMSQ), self-reported
Time frame: Baseline to week 12
Hospital Anxiety and Depression Scale (HADS-D), self-reported
Time frame: Baseline to week 12
Parkinson's Disease Questionnaire (PDQ-8) and EQ-5D-5L (including VAS), self-reported
Time frame: Baseline to week 12
Self-reported OnOff Scale questionnaire
Time frame: Baseline to week 12
Self-reported OnOff Scale questionnaire
Time frame: Baseline to week 12
Self-reported OnOff Scale questionnaire
Time frame: Baseline to week 12
Parkinson's Disease Sleep Scale (PDSS-2), self-reported
Time frame: 12 weeks
Unified Parkinson's Disease Rating Scale (UPDRS), physician-reported
Time frame: Baseline to week 12
Movement Disorder Society - Unified Parkinson's Disease Rating Scale (UPDRS), physician-reported
Time frame: Baseline to week 12
Clinical Impression of Severity Index for Parkinson's Disease (CISI-PD), physician-reported
Time frame: Baseline to week 12
Patient-Reported Outcomes in Parkinson's Disease (PRO-PD), self-reported
Publications
No exact PMID-linked public article is currently readable locally.