Health TrialsbyHealthPanel

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

ConditionPARKINSON DISEASE (Disorder)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age30+
SponsorNavamedic AB

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

58 Participants
are divided into 1 treatment group
Group A: Flexilev with OraFID and AppExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
12 weeks

Secondary outcomes

1

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

Self-reported via questionnaire on app usage and usability

Time frame
12 weeks
2

Time required per dispensation/treatment with the OraFID device

Self-reported via questionnaire regarding the device

Time frame
12 weeks
3

Compliance with the dosing schedule

Data obtained from the Levilog app and drug accountability records

Time frame
12 weeks
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Navamedic AB

Lead sponsor

Source ClinicalTrials.gov
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