Usability of Levodopa Cyclops™ vs INBRIJA® in Parkinson's Patients

Usability Clinical Trial

— DPI-6  

Official title:

Usability of Levodopa Cyclops™ Compared to INBRIJA® During an Off Episode in Parkinson's Disease Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05499572
• Other study ID #: NL82043.099.22
• Status: Recruiting
• Start date: February 29, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2024
• Source: Martini Hospital Groningen
• Contact: Marianne Luinstra, dr
• Phone: +31505246722
• Email: m.luinstra[@]mzh.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Sixteen Parkinson's patients, who are ≥ 18 years of age, regularly suffering from predictable off episodes, able to understand the inhaler user instructions (no cognitive dysfunction) and who did not previously participate in the Parkinson DPI-1,2,3,4 or 5 study or in a study using INBRIJA®.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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;
• 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™)
• Having experience with using the INBRIJA® inhaler.

Related Conditions & MeSH terms

• Parkinson Disease
• Usability

Intervention

Device:
• Inhalation maneuver with placebo Inbrija and placebo Cyclops
Patients perform the inhalation maneuvers with placebo inhalers (Inbrija and Cyclops) during a Parkinson's off episode.

Locations

Country	Name	City	State
Netherlands	Martini Ziekenhuis	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Martini Hospital Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correct performance of inhalation maneuvers	The main study parameter is to investigate whether Parkinson's patients perform the correct steps in accordance with the instruction card of respectively the Levodopa Cyclops™ or INBRIJA® inhaler after the primary inhalation instructions.	15 minutes for performing the inhalation maneuvers with both the placebo inhalers (Inbrija and Cyclops) during a Parkinson's off episode
Secondary	Inhaler preference of Parkinson patients	The secondary study parameter is to investigate whether the Parkinson's patients prefer the Levodopa Cyclops™ or the INBRIJA® inhaler by keeping track of the total handling time and by letting the patients fill in a questionnaire keeping track of their experiences regarding the ease-of-use, convenience and preference of the different steps of the inhaler user maneuver	10 minutes for filling in the questionnaire during or directly after a Parkinson's off episode