G20
Conditions
Interventions
Group 1: Patients with Parkinson’s disease and “OFF” episodes who are being treated with levodopa and a dopa decarboxylase inhibitor may use Inbrija® as needed for the intermittent treatment of episod
Sponsors
Merz Therapeutics GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: · Adult patients with Parkinson’s disease and OFF episodes who are receiving stable therapy with levodopa and a dopa decarboxylase inhibitor (benserazide or carbidopa), · Inbrija®-naive patients for whom treatment with Inbrija® is indicated and for whom the decision to initiate treatment with Inbrija®, in accordance with the prescribing information, was made independently by the treating physician prior to study enrollment, · Patients who have the necessary understanding to recognize OFF symptoms and can prepare the inhaler themselves, or who have a caregiver who can prepare the inhaler for them when needed, • written informed consent
Exclusion criteria
Exclusion criteria: · Patients who, according to the contraindications listed in the prescribing information, must not be treated with Inbrija®, Patients who are currently participating in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in cumulative OFF time per day from baseline to week 12 (based on the physician-patient interview and data from the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part IV, item 4.3) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Duration, frequency, and types of OFF episodes • Frequency, timing, and duration of action of Inbrija® • Number of capsules per inhalation • Types of OFF episodes treated • Overall assessment of the efficacy and tolerability of Inbrija® • Overall assessment of onset of action and ease of use • Discontinuation of therapy • Parkinson's Disease Questionnaire-8 (PDQ-8 (Parkinson specific quality of life) The data is collected during physician-patient interviews and through patient diaries (activity diary, Inbrija® usage diary). | — |
Countries
Germany
Contacts
Public ContactGeorg Ebersbach
Neurologisches Fachkrankenhaus für Bewegungsstörungen Parkinson
Outcome results
None listed