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A 12-Week Study of Flexilev With the OraFID Device and App in Parkinson's Patients
Sponsor: Navamedic AB
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.
Key Details
Gender
All
Age Range
30 Years - Any
Study Type
INTERVENTIONAL
Enrollment
58
Start Date
2026-05-25
Completion Date
2027-06-30
Last Updated
2026-09-24
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (5)
Karolinska University Hospital
Stockholm, Stockholm County, Sweden
Uppsala University Hospital
Uppsala, Uppsala County, Sweden
Sahlgrenska universitetssjukhuset
Gothenburg, Sweden
Skane University Hospital
Lund, Sweden
Centrum för Neurologi
Stockholm, Sweden