Levodopa inhalation powder: Levodopa inhalation powder (Inbrija®) prescribed as part of routine clinical practice for the intermittent treatment of OFF episodes in adults with Parkinson's disease receiving levodopa therapy. In this non-interventional study, treatment is determined by the treating physician independently of study participation, and no study medication is assigned by the protocol.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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®.
Primary outcome measure(s)
Mean Within-Patient Change in PDQ-39 Mobility Domain Score From Baseline to Month 3 — Baseline to Month 3 Mean within-patient change in the Parkinson's Disease Questionnaire-39 (PDQ-39) Mobility domain score from baseline (before initiation of Inbrija®) to Month 3. The PDQ-39 Mobility domain includes 10 items assessing mobility-related difficulties experienced by patients with Parkinson's disease. Scores are transformed to a 0 to 100 scale, with higher scores indicating worse mobility and poorer health-related quality of life.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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