Real-world Patient Experiences With Inbrija®
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMerz Therapeutics GmbH
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older.
Diagnosis of Parkinson's disease with a history of OFF episodes.
Able and willing to provide informed consent.
Current user of Inbrija® for OFF episodes in Parkinson's disease according to approved prescribing conditions.
Disqualifiers
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®.
Trial population
The study population consists of adults with Parkinson's disease and a history of OFF episodes who have been prescribed Inbrija® (inhaled levodopa) as part of routine clinical practice. Participants will be recruited from neurology clinics and medical centers in Austria, Germany, and Sweden. The study includes both patients newly initiating Inbrija® and current Inbrija® users. Patients initiating Inbrija® will participate in the quantitative component and complete patient-reported outcome assessments over a 3-month period. A subset of current Inbrija® users will participate in qualitative interviews to describe their experiences of OFF episodes, treatment use, and the impact of Inbrija® on daily life and quality of life.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Levodopa inhalation powder
DrugLevodopa 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Qualitative Cohort1 intervention
Group B: Quantitative Cohort1 intervention
Trial outcomes
Primary outcomes
1
Mean Within-Patient Change in PDQ-39 Mobility Domain Score From 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.
Time frame
Baseline to Month 3Secondary outcomes
1
Mean Within-Patient Change in PDQ-39 Mobility Domain Score From Baseline to Months 1 and 2
Mean within-patient change in the Parkinson's Disease Questionnaire-39 (PDQ-39) Mobility domain score from baseline to Month 1 and Month 2. Scores are transformed to a 0 to 100 scale, with higher scores indicating worse mobility and poorer health-related quality of life.
Time frame
Baseline to Month 1 and Month 22
Mean Within-Patient Change in PDQ-39 ADL, Bodily Discomfort, Stigma, and Total Scores
Mean within-patient change in Parkinson's Disease Questionnaire-39 (PDQ-39) Activities of Daily Living (ADL), Bodily Discomfort, Stigma, and Total scores from baseline to Months 1, 2, and 3. Scores are transformed to a 0 to 100 scale, with higher scores indicating worse health-related quality of life.
Time frame
Baseline to Months 1, 2, and 33
Patient Global Impression of Change (PGIC)
Proportion of patients in each Patient Global Impression of Change (PGIC) response category following initiation of Inbrija®. PGIC assesses the patient's perception of overall change in OFF episodes since starting treatment.
Time frame
Months 1, 2, and 34
Patient Global Impression of Severity (PGIS)
Proportion of patients in each Patient Global Impression of Severity (PGIS) response category at baseline and following initiation of Inbrija®. PGIS is a single-item measure that assesses the patient's overall severity of OFF episodes, with response categories of None, Mild, Moderate, Severe, and Very Severe.
Time frame
Baseline, Month 1, Month 2, and Month 3Sponsors and contacts
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Source ClinicalTrials.gov