NCT07839793RecruitingPhase 4
A 12-Week Study of Flexilev With the OraFID Device and App in Parkinson's Patients
Source: ClinicalTrials.gov · Last updated 24 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 58 (estimated)
- First submitted
- 18 Sept 2026
- Start date
- 25 May 2026
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Navamedic AB
- Diseases
- Parkinson disease
- NCT number
- NCT07839793
- EU CT number
- 2025-524296-23-01
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 58
- From 25 May 2026 to the primary completion date, 31 Mar 2027
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 30 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sahlgrenska Universitetssjukhuset Coordinator of this site? Confirm its status | Gothenburg | Sweden | Not yet recruiting |
| Skåne University Hospital Coordinator of this site? Confirm its status | Lund | Sweden | Recruiting |
| Centrum för Neurologi Coordinator of this site? Confirm its status | Stockholm | Sweden | Not yet recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Not yet recruiting |
| Uppsala University Hospital Coordinator of this site? Confirm its status | Uppsala | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.