RECRUITING Phase 4 ClinicalTrials.gov

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

Sponsor: Navamedic AB • ClinicalTrials.gov ID: NCT07839793

Registry updated: 2026-09-24

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Description

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.

Interventions

OraFID dosing device, Levodopa/Carbidopa minitablets delivered via OraFID dosing device (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.

Eligibility criteria

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.

Conditions

PARKINSON DISEASE (Disorder)

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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