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A device to help measure small medicine doses

Researchers are studying small dissolvable Parkinson’s tablets used with a dispensing device and an optional app that reminds people about doses.

Testing a treatment or activity · Study reference: NCT07839793

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

Open the official registry record ↗

Who can join?

Age 30 years and over · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Full study name & original research details

Official study title

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

Original description

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.

Further description from the registry

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 reported: PARKINSON DISEASE (Disorder)

Study type
Interventional
Interventions
OraFID dosing device, Levodopa/Carbidopa minitablets delivered via OraFID dosing device
Phases
PHASE4
Sponsor
Navamedic AB
Start date reported by registry
2026-05-25 (actual)

Registry updated: 2026-09-24 · Status last verified by the registry submitter: 2026-09

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Dag Nyholm, Professor · 0046186115003 · dag.nyholm@uu.se

Jack Spira, MD. Ph.D. · 0046722506272 · jack.spira@navamedic.com

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Karolinska University Hospital

Stockholm, Stockholm County, Sweden

Not yet recruiting

Anders Johansson, MD, PhD · 0046812373424 · anders.c.johansson@regionstockholm.se

Uppsala University Hospital

Uppsala, Uppsala County, Sweden

Recruiting

Dag Nyholm, Professor · 0046186115003 · dag.nyholm@uu.se

Davide Paonessa, MD

Sahlgrenska universitetssjukhuset

Gothenburg, Sweden

Not yet recruiting

Filip Bergquist, Professor · 0046317863425 · filip.bergquist@gu.se

Skane University Hospital

Lund, Sweden

Recruiting

Per Odiin, Professor · 004646175649 · per.odin@med.lu.se

Centrum för Neurologi

Stockholm, Sweden

Not yet recruiting

Per Svenningsson, MD, PhD. Professor · 004682379990 · per.svenningsson@regionstockholm.se

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.