G20
Conditions
Interventions
Group 1: Since this is a non-interventional study, the treatment of patients with Xadago® is carried out according to the current summary of product characteristics within the approved indication. Pat
Sponsors
Zambon GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • The patient is at least 18 years old at time point of enrollment into the study • Diagnosis of mid- to late-stage fluctuating PD • The patient has not yet been treated with Xadago® • The patient receives a stable dose of L-Dopa • The decision to initiate the treatment with Xadago® has been made by the treating physician considering the indications of the SmPC • The patient has been informed about the study in detail by the physician and the written informed consent of the patient (resp. his/her statutory representative) to the participation in the study has been obtained
Exclusion criteria
Exclusion criteria: • Hypersensitivity to the active substance or to any of the excipients • Concomitant treatment with other monoamine oxidase (MAO) inhibitors • Concomitant treatment with pethidine • severe hepatic impairment • albinism, retinal degeneration, uveitis, inherited retinopathy or severe progressive diabetic retinopathy Also, following patients will not be included in the study according to the SmPC: • Women of childbearing potential without adequate contraception • Pregnant women • Breast-feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective of this non-interventional study is to gain insight into the efficacy and safety of Xadago® directly after market launch in a wide population of patients with idiopathic PD within the approved indication during routine clinical care. With the aid of commonly used diagnostic methods, particularly motor and non-motor symptoms, influence on quality of life, and adverse effects of the therapy shall be determined. The following questionnaires are used: - at start of observation: Assessment of motor symptoms via Physician questionnaire MDS-UPDRS, Part III; Assessment of non-motor symptoms via Physician questionnaire NMSS; Assessment of dyskinesia via Physician questionnaire AIMS; Assessment of quality of life via Patient questionnaire PDQ-8 - approx. 3 months after start of observation: Assessment of non-motor symptoms via Physician questionnaire NMSS; Assessment of dyskinesia via Physician questionnaire AIMS - End of observation (approx. 6 months after start of observation resp. at premature termination): Assessment of motor symptoms via Physician questionnaire MDS-UPDRS, Part III; Assessment of non-motor symptoms via Physician questionnaire NMSS; Assessment of dyskinesia via Physician questionnaire AIMS; Assessment of quality of life via Patient questionnaire PDQ 8. Treatment with Xadago® and other Parkinson's add-on therapies as well as all adverse events occurring under treatment are continuously documented. Abbreviations: MDS-UPDRS: : Movement Disorder Society-Sponsored Revision of the Unified Parkinson’s Disease Rating Scale NMSS: Non-Motor Symptoms Scale AIMS: Abnormal Involuntary Movement Scale PDQ-8: Parkinson's Disease Quality of Life Questionnaire | — |
Countries
Germany
Contacts
Public ContactDietrich Bosse
Zambon GmbH
Outcome results
None listed