NCT05499572Completed
Usability of Levodopa Cyclops™ vs INBRIJA® in Parkinson's Patients
Usability of Levodopa Cyclops™ Compared to INBRIJA® During an Off Episode in Parkinson's Disease Patients
Source: ClinicalTrials.gov · Last updated 25 Jul 2024
Brief summary (registry, in English)
Currently there is one Levodopa inhaler on the market, the INBRIJA® inhaler. When looking at the user instructions for the INBRIJA®, multiple steps are necessary including preparing and cleaning the inhaler. The Levodopa Cyclops™ inhaler also requires steps to be ready-for-use, however there are less steps required to reach this 'ready-for-use' state. This is mainly because the medicine (Levodopa) is already prefilled in the inhaler. Moreover, the Levodopa Cyclops™ is a single-use inhaler and cleaning steps are not necessary. Since both inhalers should be used during off episodes, there might be a preference for one inhaler over the other due to the instructions. An off episode might impair the ability and length to successfully operate an inhaler due to mental or mobility issues. This study investigates if Parkinson patients have a preference for one of the inhalers based on handling steps, ease-of-use, understandability.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 16 (actual)
- First submitted
- 8 Aug 2022
- Start date
- 29 Feb 2024
- Primary completion date
- 2 Jul 2024
- Lead sponsor
- Martini Hospital Groningen
- Diseases
- Parkinson disease
- NCT number
- NCT05499572
What you commit to
- Study type: Observational
- Participants enrolled: 16
- From 29 Feb 2024 to the primary completion date, 2 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously participated in the Parkinson DPI-1, DPI-2, DPI-3, DPI-4 or DPI-5 study (prior knowledge of the inhalation maneuver of the Levodopa Cyclops™)
Other
- Not able to understand an inhalation instruction of either the Levodopa Cyclops™ or the INBRIJA® (within a maximum of 20 minutes of explanation per inhaler);
- Cognitive dysfunction, which precludes good understanding of instructions and/or informed consent;
- Having experience with using the INBRIJA® inhaler.
Who the study is looking for
- Diagnosed with Parkinson's disease by a neurologist;
- At least 18 years of age;
- Regularly suffering from predictable off episodes despite medication;
- Recognizable off episodes for themselves and others;
- Signed informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Martini Ziekenhuis Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.