Flexilev small tablets with a dosing device and app in Parkinson's disease
Tests how well people with Parkinson's disease manage Flexilev tablets with a dosing device.
Plain-language title generated from the registry record
Registry title: A 12-Week Study of Flexilev With the OraFID Device and App in Parkinson's Patients
Key facts
- Where
- Gothenburg, Lund, Stockholm, and Uppsala, SwedenSee the 5 sites
- Phase
- Phase 4
Where in Sweden
- Sahlgrenska UniversitetssjukhusetGothenburg, SwedenNot yet recruiting
- Skåne University HospitalLund, SwedenTaking people
- Centrum för NeurologiStockholm, SwedenNot yet recruiting
- Karolinska University HospitalStockholm, SwedenNot yet recruiting
- Uppsala University HospitalUppsala, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Navamedic AB
- Trial code
- NCT07839793EU 2025-524296-23-01
- Record updated
- 24 September 2026
- Original 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.Read full original descriptionShow less
A 12-Week Study of Flexilev With the OraFID Device and App in Parkinson's Patients
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.
Inclusion: 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: Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception; 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.