PARKINSON DISEASE (Disorder)Phase 4FLORANCT07839793
A 12-Week Study of Flexilev With the OraFID Device and App in Parkinson's Patients
A Phase 4 study testing OraFID dosing device, Levodopa/Carbidopa minitablets delivered via OraFID dosing device in people with PARKINSON DISEASE (Disorder), run by Navamedic AB at 5 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- PARKINSON DISEASE (Disorder)
- What is being tested?
- OraFID dosing device, Levodopa/Carbidopa minitablets delivered via OraFID dosing device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 5 sitesSweden
- Study dates
- 25 May 2026to 30 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Have a smartphone (either patient or caregiver)
- Ability to consent and comply with study specific procedures
- Able to read and write in Swedish
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Sweden5 sites, 5 recruiting
- Not yet recruiting
Sahlgrenska universitetssjukhuset
Gothenburg, 413 45
Filip Bergquist, Professor, 0046317863425, filip.bergquist@gu.se
- Recruiting
Skane University Hospital
Lund, 222 42
Per Odiin, Professor, 004646175649, per.odin@med.lu.se
- Not yet recruiting
Karolinska University Hospital
Stockholm, Stockholm County
Anders Johansson, MD, PhD, 0046812373424, anders.c.johansson@regionstockholm.se
- Not yet recruiting
Centrum för Neurologi
Stockholm, 113 65
Per Svenningsson, MD, PhD. Professor, 004682379990, per.svenningsson@regionstockholm.se
- Recruiting
Uppsala University Hospital
Uppsala, Uppsala County, 751 85
Dag Nyholm, Professor, 0046186115003, dag.nyholm@uu.se
Davide Paonessa, MD
About this study
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.
Read the detailed description
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.
- Conditions
- PARKINSON DISEASE (Disorder)
- Being tested
- OraFID dosing device, Levodopa/Carbidopa minitablets delivered via OraFID dosing device
- Keywords
- Parkinson's Disease, Levodopa, Carbidopa, Flexilev, OraFID, Precision dosing, Individualized dosing, Dose titration, Minitablets
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OraFID dosing device, Levodopa/Carbidopa minitablets delivered via OraFID dosing deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Flexilev with OraFID and App | Experimental | 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. Receives: Device: OraFID dosing device, Levodopa/Carbidopa minitablets delivered via OraFID dosing device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (18)
User opinion, usage, and ability to use the Levilog app
Self-reported via questionnaire on app usage and usability
Measured: 12 weeks
Time required per dispensation/treatment with the OraFID device
Self-reported via questionnaire regarding the device
Measured: 12 weeks
Compliance with the dosing schedule
Data obtained from the Levilog app and drug accountability records
Measured: 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
Measured: 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
Measured: 12 weeks
Overall acceptability of Flexilev/OraFID/App
Self-reported via questionnaire regarding the device
Measured: 12 weeks
User opinion of Flexilev treatment
Self-reported via questionnaire regarding treatment
Measured: 12 weeks
Change in non-motor symptoms
Non-Motor Symptoms Questionnaire (NMSQ), self-reported
Measured: Baseline to week 12
Change in depression symptoms
Hospital Anxiety and Depression Scale (HADS-D), self-reported
Measured: Baseline to week 12
Change in quality of life
Parkinson's Disease Questionnaire (PDQ-8) and EQ-5D-5L (including VAS), self-reported
Measured: Baseline to week 12
Change in symptom variation (On-Off phenomena)
Self-reported OnOff Scale questionnaire
Measured: Baseline to week 12
Change in average daily normalized "off" time
Self-reported OnOff Scale questionnaire
Measured: Baseline to week 12
Change in average daily normalized "on" time without troublesome dyskinesia
Self-reported OnOff Scale questionnaire
Measured: Baseline to week 12
Change in sleep quality
Parkinson's Disease Sleep Scale (PDSS-2), self-reported
Measured: Baseline to week 12
Motor function in daily life
Unified Parkinson's Disease Rating Scale (UPDRS), physician-reported
Measured: 12 weeks
Change in motor function (UPDRS Parts II and III)
Movement Disorder Society - Unified Parkinson's Disease Rating Scale (UPDRS), physician-reported
Measured: Baseline to week 12
Change in disease severity
Clinical Impression of Severity Index for Parkinson's Disease (CISI-PD), physician-reported
Measured: Baseline to week 12
Change in symptoms, treatment effects, and overall quality
Patient-Reported Outcomes in Parkinson's Disease (PRO-PD), self-reported
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start25 May 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group of participants receives Flexilev/OraFID/App treatment; no comparator arm.
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navamedic AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839793
- Sponsor's protocol ID
- Nava-25-01
- Other IDs
- 2025-524296-23-01, 2025
- Acronym
- FLORA
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Week Study of Flexilev With the OraFID Device and App in Parkinson's Patients
- ClinicalTrials.gov ID
- NCT07839793
- Acronym / sponsor ID
- FLORA / Nava-25-01
- Conditions
- PARKINSON DISEASE (Disorder)
- Keywords
- Parkinson's Disease, Levodopa, Carbidopa, Flexilev, OraFID, Precision dosing, Individualized dosing, Dose titration, Minitablets
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Navamedic ABIndustry (pharma, biotech, devices)
- Study start
- 25 May 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group of participants receives Flexilev/OraFID/App treatment; no comparator arm.
| Arm | Type | Receives |
|---|---|---|
| Flexilev with OraFID and App | Experimental | Device: OraFID dosing device, Levodopa/Carbidopa minitablets delivered via OraFID dosing deviceParticipants 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OraFID dosing device, Levodopa/Carbidopa minitablets delivered via OraFID dosing deviceIntervention 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. | Device | Flexilev with OraFID and App |
Primary outcome
Patient acceptability and satisfaction with the OraFID dosing device, self-reported via questionnaire
Time frame: 12 weeks
Assessed using a patient-reported questionnaire evaluating acceptability, ease of use, and satisfaction with the OraFID dosing device.
18 secondary outcomes
User opinion, usage, and ability to use the Levilog app
Time frame: 12 weeks
Time required per dispensation/treatment with the OraFID device
Time frame: 12 weeks
Compliance with the dosing schedule
Time frame: 12 weeks
Compliance with the app, i.e., willingness to register doses
Time frame: 12 weeks
Safety and acceptability of Flexilev delivered by OraFID and the app
Time frame: 12 weeks
Overall acceptability of Flexilev/OraFID/App
Time frame: 12 weeks
User opinion of Flexilev treatment
Time frame: 12 weeks
Change in non-motor symptoms
Time frame: Baseline to week 12
Change in depression symptoms
Time frame: Baseline to week 12
Change in quality of life
Time frame: Baseline to week 12
Change in symptom variation (On-Off phenomena)
Time frame: Baseline to week 12
Change in average daily normalized "off" time
Time frame: Baseline to week 12
Change in average daily normalized "on" time without troublesome dyskinesia
Time frame: Baseline to week 12
Change in sleep quality
Time frame: Baseline to week 12
Motor function in daily life
Time frame: 12 weeks
Change in motor function (UPDRS Parts II and III)
Time frame: Baseline to week 12
Change in disease severity
Time frame: Baseline to week 12
Change in symptoms, treatment effects, and overall quality
Time frame: Baseline to week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OraFID dosing device, Levodopa/Carbidopa minitablets delivered via OraFID dosing device in people with PARKINSON DISEASE (Disorder), run by Navamedic AB at 5 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dag Nyholm, Professor (0046186115003, dag.nyholm@uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient acceptability and satisfaction with the OraFID dosing device, self-reported via questionnaire (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.