A 12-Week Study of Flexilev With the OraFID Device and App in Parkinson's Patients
- PARKINSON DISEASE (Disorder)
At a glance
- Phase
- Phase 4
- Study type
- Interventional
- Sponsor
- Navamedic AB
- Enrolment target
- 58
- Started
- 25 May 2026
- Main results due
- 31 March 2027
- Study sites
- 5
- Registry updated
- 24 September 2026
Can you take part?
- Aged 30 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(5)
Karolinska University Hospital
Stockholm, Stockholm County, Sweden
Not yet recruiting
Uppsala University Hospital
Uppsala, Uppsala County, Sweden
Recruiting
Sahlgrenska universitetssjukhuset
Gothenburg, Sweden
Not yet recruiting
Skane University Hospital
Lund, Sweden
Recruiting
Centrum för Neurologi
Stockholm, Sweden
Not yet recruiting
Showing 5 of 5 sites. 2 of the 5 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07839793. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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