A 12-Week Study of Flexilev With the OraFID Device and App in Parkinson's Patients

NCT07839793 | Recruiting Phase 4

• 3 other identifiers: Nava-25-012025-524296-23-012025
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 5

Brief 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. 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.

Conditions

PARKINSON DISEASE (Disorder)

Keywords

Parkinson's Disease, Levodopa, Carbidopa, Flexilev, OraFID, Precision dosing, Individualized dosing, Dose titration, Minitablets

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (18)

• User opinion, usage, and ability to use the Levilog app

  12 weeks

• Time required per dispensation/treatment with the OraFID device

  12 weeks

• Compliance with the dosing schedule

  12 weeks

• Compliance with the app, i.e., willingness to register doses

  12 weeks

• Safety and acceptability of Flexilev delivered by OraFID and the app

  12 weeks

Study Arms (1)

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.

Device: OraFID dosing device, Levodopa/Carbidopa minitablets delivered via OraFID dosing device

Interventions

OraFID dosing device, Levodopa/Carbidopa minitablets delivered via OraFID dosing device 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.

Flexilev with OraFID and App

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Navamedic AB: lead

Study Sites (5)

Karolinska University Hospital

Stockholm, Stockholm County, Sweden

NOT YET RECRUITING

Uppsala University Hospital

Uppsala, Uppsala County, 751 85, Sweden

RECRUITING

Sahlgrenska universitetssjukhuset

Gothenburg, 413 45, Sweden

NOT YET RECRUITING

Skane University Hospital

Lund, 222 42, Sweden

RECRUITING

Centrum för Neurologi

Stockholm, 113 65, Sweden

NOT YET RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Dag Nyholm, Professor

CONTACT

0046186115003; dag.nyholm@uu.se

Jack Spira, MD. Ph.D.

CONTACT

0046722506272; jack.spira@navamedic.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single group of participants receives Flexilev/OraFID/App treatment; no comparator arm.

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 24, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (5)