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An observational study of carbidopa and levodopa use with a new dispensing device and app in patients with Parkinson’s disease

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Region Stockholm – SLSO Stockholm Sweden
Region Skane Skanes Universitetssjukhus Lund Sweden
Karolinska University Hospital Solna Sweden
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Liexygdzyv Uzpxicarghs Linkoping Sweden
Uyfnjjv Upxvawgvdd Hqtwtija Uppsala Sweden

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Sweden Sweden
Not yet recruiting
01.04.2026

Trial locations

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.

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 ID:
2025-524296-23-01
Protocol code:
Nava-25-01
Trial Phase:
Therapeutic confirmatory (Phase III)

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