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

RecruitingPhase 4Ages 30 Years - anyAllNavamedic AB
NCT07839793 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • OraFID dosing device, Levodopa/Carbidopa minitablets delivered via OraFID dosing device
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Where

5 sites
Karolinska University Hospital
Stockholm, Sweden
Uppsala University Hospital
Uppsala, Sweden
Sahlgrenska universitetssjukhuset
Gothenburg, Sweden
Skane University Hospital
Lund, Sweden
Centrum för Neurologi
Stockholm, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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