Karolinska University Hospital
Solna, Sweden
Recruiting
An observational study of carbidopa and levodopa use with a new dispensing device and app in patients with Parkinson's disease
Verified siteRegistered drug
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This study focuses on individuals living with Parkinson's disease, a condition that affects the movement of the body. The research involves the use of a medication called Flexilev, which contains two active ingredients, levodopa and carbidopa. The purpose of the study is to evaluate a new medicine dispenser known as OraFID along with a digital mobile application.
During the 12-week study, participants will use the OraFID device to help manage their medication and a mobile app to record information. This period allows for the observation of how the dispenser and the application work in daily life while taking the prescribed treatment.
The research process
The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
10 criteria
- Both men and women can participate if they are at least 30 years old at the time of the initial screening.
- Participants must have idiopathic Parkinson's disease, which is a type of Parkinson's disease that occurs for unknown reasons, and it must respond to levodopa, a specific medication used to treat symptoms.
- Participants must take their levodopa medication at least 4 times every day.
- Medication doses must have remained stable, meaning the amount and timing of the medicine have not changed, for at least the last 4 weeks.
- A study doctor must determine that the participant is suitable for Flexilev treatment.
- The participant or their caregiver (a person who helps look after the patient) must show they can correctly use and understand the OraFID delivery system, which is the device used to give the medicine.
- The participant or their caregiver must agree to use the Patient's Own Reporting module, a digital tool used to record health information, and must be willing to complete all questionnaires (sets of questions).
- The participant or their caregiver must own a smartphone.
- Participants must be able to provide informed consent (agreeing to join the study after understanding all the details) and follow all the rules of the study.
- Participants must be able to read and write in Swedish.
Who cannot join the trial?
4 criteria
- The person or their caregiver (a person who helps look after a patient) cannot use the new device.
- Female patients who are pregnant (expecting a baby) or breast-feeding (feeding a baby with milk from the breast) cannot participate.
- Female patients who plan to become pregnant during the study or for three months after the study ends cannot participate.
- Female patients of childbearing age (women who are able to have children) who are not using adequate contraception (reliable methods to prevent pregnancy, such as birth control) cannot participate.
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Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Verified Verified Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
Gothenburg, SwedenVerified Region Skane Skanes Universitetssjukhus
Lund, Sweden
Trial locations
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Investigated drugs
Flexilev is a combination medication used to help manage the symptoms of Parkinson's disease. It contains two active ingredients that work together to increase the levels of dopamine in the brain, which helps improve movement and control.
What is already known about the treatment
Carbidopa
This medication is taken by mouth and works by preventing a specific enzyme in the body from breaking down its partner medicine before it reaches the brain. It is widely used in standard medical practice to help manage symptoms of Parkinson's disease by making other treatments more effective and reducing side effects. As a decarboxylase inhibitor, it acts as a supporting agent that ensures the main treatment reaches its intended target in the nervous system.
Levodopa
This medication is administered orally to help improve movement in people living with Parkinson's disease. It is the most common and effective treatment currently available in medicine for managing this condition. On a molecular level, it enters the brain and is converted into dopamine, a natural chemical that helps control body movements and coordination.
Investigated diseases
Parkinson's disease - This is a condition that affects the nervous system and impacts body movement. It occurs when certain nerve cells in the brain gradually decrease in number and lose function. This loss leads to various physical changes, such as tremors, stiffness, and difficulty with balance or walking. Over time, the movement difficulties may become more pronounced and affect daily activities. The condition also involves changes in how the brain controls motor functions.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524296-23-01Protocol codeNava-25-01Estimated enrolment58 patientsSponsorNavamedic AB
sourced from the EU Clinical Trials Register and site verification
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