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Real-world Patient Experiences With Inbrija®
Real-world Patient Experiences With Inbrija®

NCT07797790

Not Yet RecruitingN/A

Sponsor: Merz Therapeutics GmbH

Conditions: Parkinson Disease (PD), Parkinson's Disease, Off Episodes of Parkinson Disease

Interventions: Levodopa inhalation powder

Countries: Austria

Parkinson's disease can cause OFF episodes, when medication effects wear off and symptoms return, affecting movement, daily activities, comfort, and wellbeing. This study aims to explore the experiences of people with Parkinson's disease who are prescribed Inbrija® as part of their usual care. Through a mixed-methods approach, the study will examine how OFF episodes affect patients, what influences their decision to use Inbrija®, and whether patient-reported outcomes related to symptoms, daily functioning, and quality of life change during the first 3 months of treatment. The study is planned to be conducted at approximately 7 sites in Austria, Germany, and Sweden and will enroll up to 120 participants receiving Inbrija® in routine clinical practice.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

* Adults aged 18 years or older.
* Diagnosis of Parkinson's disease with a history of OFF episodes.
* Able and willing to provide informed consent.

For the Quantitative Component:

• Physician decision to initiate Inbrija® for the treatment of OFF episodes in Parkinson's disease according to routine clinical practice prior to enrollment.

For the Qualitative Component:

* Current user of Inbrija® for OFF episodes in Parkinson's disease according to approved prescribing conditions.
* At least 6 weeks of regular Inbrija® use (minimum 4 uses during the previous month).
* Able to participate in a 60-minute interview using an internet-enabled device.

Exclusion Criteria:

For the Quantitative Component:

* Previous use of Inbrija® before study enrollment.
* Participation in an interventional Parkinson's disease clinical trial within 3 months prior to Inbrija® initiation.
* Residence outside Austria, Germany, or Sweden.
* Current use of an on-demand treatment for OFF episodes other than Inbrija®.

For the Qualitative Component:

* Participation in an interventional Parkinson's disease clinical trial within 3 months prior to enrollment.
* Residence outside Austria or Germany.
* Current use of an on-demand treatment for OFF episodes other than Inbrija®.
Locations (2)
  • Altmünster, Austria
  • Graz, Austria