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Patient Evaluation of OraFID, a New Medicine Dispenser and App for Flexilev minitablets
EU CTIS ID: 2025-524296-23-01
What this study is testing
Patient evaluation of a new dispensing device
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.