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

Study acronym: FLORA
StatusRecruiting
PhasePhase 4
Started

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Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07839793
Lead Sponsor Navamedic AB
Conditions
(from sponsor)
PARKINSON DISEASE (Disorder)
Related terms Parkinson Disease
Enrollment 58 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov