Patient Evaluation of OraFID, a New Medicine Dispenser and App for Flexilev minitablets

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Navamedic AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Decision date (initial)

2026-02-24

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Navamedic AB

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

Patient evaluation of a new dispensing device

Secondary objectives 18

1. To evaluate user opinion, usage and ability to use the app
2. To evaluate treatment time used per dispensation/treatment
3. To evaluate the compliance with the treatment schedule
4. To evaluate the compliance with the app, i.e. subjects willingness to register doses in the app
5. To assess the safety and acceptability of Flexilev when delivered by the OraFID dosing device and accompanying app.
6. To evaluate overall acceptability of Flexilev/OraFID/App in subjects with PD during 12 weeks of therapy.
7. To evaluate user opinion of the treatment with Flexilev
8. To evaluate change in non-motor symptoms - NMSQ
9. To evaluate change in depression - HADS-D
10. To evaluate change in Quality of Life PDQ-8 and EQ-5D-5L
11. To evaluate change symptom variations (On-Off)
12. To evaluate change from baseline to week 12 of the treatment period in average daily normalized "off" time (hours)
13. To evaluate change in sleep PDSS-2
14. To evaluate change from baseline to week 12 of the treatment period in average daily normalized "on" time without troublesome dyskinesia
15. To evaluate Motor function in daily life using UPDRS
16. To evaluate change from baseline to week 12 movement disorder society - unified Parkinson’s disease rating scale (UPDRS) part II and III
17. To evaluate change from baseline to week 12 in disease severity using CISI-PD scale
18. To evaluate change from baseline to week 12 in symptoms, treatment effects, and overall quality using PRO-PD scale

Conditions and MedDRA coding

Parkinsons Disease

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. 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
2. Have a minimum of 4 levodopa dosing occasions per day
3. Stable medication within the last 4 weeks
4. Be judged by the investigator to be eligible for Flexilev treatment.
5. Subject (or caregiver, if applicable) demonstrates the understanding and correct use of the OraFID delivery system, as assessed by the investigator or designee.
6. 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.
7. Have a smartphone (either patient or caregiver)
8. Ability to consent and comply with study specific procedures
9. Able to read and write in Swedish

Exclusion criteria 3

1. Inability of subject or caregiver to use the device
2. 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.
3. Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Self-reported using questionnaire regarding the device (self-reported in Patients Own Registration in “Parkinsonregistret”)

Secondary endpoints 18

1. Self-reported using questionnaire regarding the app (self-reported in Patients Own Registration in “Parkinsonregistret”)
2. Self-reported using questionnaire regarding the device (self-reported in Patients Own Registration in “Parkinsonregistret”)
3. Data obtained from the app Levilog and drug accountability records.
4. Compliance with APP (Levilog) – and treatment data from use of APP (self-reported in Patients Own Registration in “Parkinsonregistret” + data obtained from the app)
5. Safety reporting; adverse event and serious adverse events,withdrawals
6. Self-reported using questionnaire regarding the device (self-reported in Patients Own Registration in “Parkinsonregistret”)
7. Self-reported using questionnaire regarding the device (self-reported in Patients Own Registration in “Parkinsonregistret”)
8. NMSQ, Non-Motor Symptoms Questionnaire (NMSQ self-reported in Patients Own Registration in “Parkinsonregistret”).
9. HADS-D, Hospital Anxiety and Depression Scale, (HADS-D self-reported in Patients Own Registration in “Parkinsonregistret”).
10. PDQ-8, Parkinson's disease quality-of-life scale, and the EQ5D-5L (EuroQol) generic quality of life scale, together with the associated 0 to 100-point visual analog scale (VAS), (self-reported in Patients Own Registration in “Parkinsonregistret”).
11. OnOff - Self-reported OnOff Scale questionnaire (OnOff self-reported in Patients Own Registration in “Parkinsonregistret”).
12. OnOff - Self-reported OnOff Scale questionnaire (OnOff self-reported in Patients Own Registration in “Parkinsonregistret”).
13. PDSS-2 questionnaire (PDSS-2 self-reported in Patients Own Registration in “Parkinsonregistret”).
14. OnOff - Self-reported OnOff Scale questionnaire (OnOff self-reported in Patients Own Registration in “Parkinsonregistret”).
15. UPDRS, Unified Parkinson’s Disease Rating Scale (Physician reported in “Parkinsonregistret”)
16. UPDRS, Unified Parkinson’s Disease Rating Scale (Physician reported in “Parkinsonregistret”)
17. CISI-PD, Clinical Impression of Severity Index for Parkinson’s Disease (Physician reported in “Parkinsonregistret”)
18. The PRO-PD, Patient-Reported Outcomes in Parkinson's Disease, (PRO-PD self-reported in Patients Own Registration in “Parkinsonregistret”).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Navamedic AB

Sponsor organisation

Navamedic AB

Address

Goteborgsvagen 74

City

Savedalen

Postcode

433 63

Country

Sweden

Scientific contact point

Organisation

Navamedic AB

Contact name

Jack Spira

Public contact point

Organisation

Navamedic AB

Contact name

Jack Spira

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications