Real-world Patient Experiences With Inbrija®

N/ANot Yet RecruitingNCT07797790

Merz Therapeutics GmbH120 enrolled

Overview

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.

INHALE-PD is a multicenter, non-interventional observational study conducted in Austria, Germany, and Sweden. The study will enroll adults with Parkinson's disease who experience OFF episodes and have been prescribed Inbrija® as part of routine clinical care. The study aims to characterize patient experiences of OFF episodes and to assess patient-reported outcomes associated with Inbrija® use in routine clinical practice. Using qualitative interviews and patient-reported outcome assessments, the study will explore the impact of OFF episodes on patients' daily lives, factors influencing the use of Inbrija®, and changes in patient-reported outcomes during the observation period.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Parkinson Disease (PD)Parkinson's Disease Off Episodes of Parkinson Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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®.

Outcomes

Primary Outcomes

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 3

Secondary Outcomes

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 2

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 3

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 3

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 3