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RECRUITING
NCT07839793
PHASE4

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

Sponsor: Navamedic AB

View on ClinicalTrials.gov

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

Interventions

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.

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