A Phase 4 interventional study of OraFID dosing device, Levodopa/Carbidopa minitablets delivered via OraFID dosing device in PARKINSON DISEASE (Disorder), sponsored by Navamedic AB. Recruiting at 5 sites in Sweden. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Navamedic AB · Phase 4, Interventional, and Device feasibility
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Among 79 studies in Parkinson Disease with a site in Sweden — 14 open to participants now, 18 under way, none of them phase 3. Parkinson Disease · Sweden.
Among the 79 studies in Parkinson Disease with a site in Sweden, this one is the 38th largest by planned enrollment of the 61 interventional ones that give a count, is one of 4 that started in 2026, is one of 7 in phase 4, reaches primary completion later than 7 of the 17 other live ones, and was the 79th registered.
4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.
Browse Parkinson Disease studies →14 of the 79 studies in Parkinson Disease with a site in Sweden are open now. Recruiting first, the newest first:
Lund University · Sites in Sweden
Ages 18+
University Hospital Tuebingen · Sites in Sweden, France, Germany and 4 more countries
Ages 35–80
Karolinska Institutet · Sites in Sweden
Ages 18+
AbbVie · Sites in Sweden, Austria, Netherlands and 1 more country
Ages 18+
Karolinska Institutet · Sites in Sweden
A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →
Of the 750 Parkinson Disease studies recruiting now, 312 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 64 take children under 18; 190 take healthy volunteers.
This study: 30 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
79 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 12 · Phase 2 15 · Phase 3 14 · Phase 4 7
First in 2002; this study’s year is marked. 4 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 58 is above the median of 40 across 3,355 interventional studies indexed under Parkinson Disease.
Median enrollment 89 across the 61 interventional studies, 316 across the 18 observational. Of the 57 that completed or were terminated, 20 (35%) have results posted.
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43 of 79 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Navamedic AB as lead sponsor.
Navamedic AB has 1 study filed under Parkinson Disease — fewer than ten, so there is no comparison to draw.
5 of the studies in Parkinson Disease with a site in Sweden that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06891703AC Immune SA[18F]ACI-15916 PET in α-synucleinopathies | 2026-12 |
| NCT06901869Karolinska InstitutetPhysical Activity in Persons With Parkinson's Disease | 2026-12 |
| NCT05635409Region SkaneA Trial to Determine the Safety and Tolerability of Transplanted Stem Cell Derived Dopamine Neurons to the Brains of Individuals With Parkinson's Disease | 2027-01 |
| NCT07839793Navamedic ABA 12-Week Study of Flexilev With the OraFID Device and App in Parkinson's Patients | 2027-03-31 |
| NCT05573542Örebro University, SwedenEarly Signs of Parkinsons Disease in IBS | 2027-10 |
Add all 5 to your calendar (.ics) → With an account.
Among the 79 studies in Parkinson Disease with a site in Sweden, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
This is an open-label, observational, up to 12-week study evaluating patients' experience with Flexilev minitablets delivered through the OraFID dosing device and the Levilog reminder app.
Participants first complete an up-to-two-week run-in period, during which their current treatment is recorded and eligibility is assessed. Eligible patients then switch to Flexilev delivered by OraFID, are trained on the device and app, and receive an individualized dosing schedule based on their doctor's evaluation and prior treatment. Other daytime levodopa medications are stopped during the study, though slow-release levodopa is allowed at night; levodopa infusions are not permitted.
Within a week of starting treatment, patients receive a follow-up phone call to confirm or adjust the dosing schedule and check for any safety or device/app issues. This is followed by a 12-week treatment period, with phone check-ins at weeks 4 and 8 and an in-person visit at week 12. Dose adjustments are permitted throughout the study if needed.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive individualized Flexilev (levodopa/carbidopa) minitablet treatment delivered via the OraFID dosing device, with an optional Levilog reminder app to support dosing compliance, over a 12-week treatment period.
Device: OraFID dosing device, Levodopa/Carbidopa minitablets delivered via OraFID dosing 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.
Patient acceptability and satisfaction with the OraFID dosing device, self-reported via questionnaire
Assessed using a patient-reported questionnaire evaluating acceptability, ease of use, and satisfaction with the OraFID dosing device.
Time frame: 12 weeks
User opinion, usage, and ability to use the Levilog app
Self-reported via questionnaire on app usage and usability
Time frame: 12 weeks
Time required per dispensation/treatment with the OraFID device
Self-reported via questionnaire regarding the device
Time frame: 12 weeks
Compliance with the dosing schedule
Data obtained from the Levilog app and drug accountability records
Time frame: 12 weeks
Compliance with the app, i.e., willingness to register doses
Compliance and treatment data from Levilog app use, combined with self-reported data
Time frame: 12 weeks
Safety and acceptability of Flexilev delivered by OraFID and the app
Assessed via adverse event and serious adverse event reporting, and study withdrawals
Time frame: 12 weeks
Overall acceptability of Flexilev/OraFID/App
Self-reported via questionnaire regarding the device
Time frame: 12 weeks
User opinion of Flexilev treatment
Self-reported via questionnaire regarding treatment
Time frame: 12 weeks
Change in non-motor symptoms
Non-Motor Symptoms Questionnaire (NMSQ), self-reported
Time frame: Baseline to week 12
Change in depression symptoms
Hospital Anxiety and Depression Scale (HADS-D), self-reported
Time frame: Baseline to week 12
Change in quality of life
Parkinson's Disease Questionnaire (PDQ-8) and EQ-5D-5L (including VAS), self-reported
Time frame: Baseline to week 12
Change in symptom variation (On-Off phenomena)
Self-reported OnOff Scale questionnaire
Time frame: Baseline to week 12
Change in average daily normalized "off" time
Self-reported OnOff Scale questionnaire
Time frame: Baseline to week 12
Change in average daily normalized "on" time without troublesome dyskinesia
Self-reported OnOff Scale questionnaire
Time frame: Baseline to week 12
Change in sleep quality
Parkinson's Disease Sleep Scale (PDSS-2), self-reported
Time frame: Baseline to week 12
Motor function in daily life
Unified Parkinson's Disease Rating Scale (UPDRS), physician-reported
Time frame: 12 weeks
Change in motor function (UPDRS Parts II and III)
Movement Disorder Society - Unified Parkinson's Disease Rating Scale (UPDRS), physician-reported
Time frame: Baseline to week 12
Change in disease severity
Clinical Impression of Severity Index for Parkinson's Disease (CISI-PD), physician-reported
Time frame: Baseline to week 12
Change in symptoms, treatment effects, and overall quality
Patient-Reported Outcomes in Parkinson's Disease (PRO-PD), self-reported
Time frame: Baseline to week 12
Plan to share: No — Individual participant data will not be shared, in order to protect participant privacy and in accordance with the data protection terms outlined in the study's informed consent.
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Mar 2027, 10 months after the start.
Of 56 phase 4 interventional studies under Parkinson Disease, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 65. This study's planned 10 months is below that.
How these figures are worked out, and which studies are left out of them.
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