G20
Conditions
Interventions
Group 1: Identification of suboptimally managed PD patients by questions from the MANAGE PD tool and assessment of quality of life and clinical course in daily practice by using the following question
amended version including hours for items 32 and 39)
- PDSS-2
- Hoehn & Yahr stage
- TSQM-14
- Changes in Parkinson's treatment and reason for change or no change in current medication
At baseline, vi
Sponsors
NeuroTransData GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • male, female, or non-binary • Patients with confirmed idiopathic Parkinson’s disease • Using oral levodopa treatment • Patients with Parkinson’s disease in MANAGE PD categories 2 and 3 • Willingness to sign and date a Patient Authorization Form to use and disclose personal health information (or informed consent form if required) • Being able to speak and understand the language of the provided patient questionnaire
Exclusion criteria
Exclusion criteria: • Participation in a concurrent clinical study • Patients with Parkinson’s disease in MANAGE PD category 1 • Significant uncertainty around the diagnosis of PD (i.e. symptoms present such as early falls or early autonomic disturbances or lack of levodopa responsiveness) • Current or past treatment with a device aided therapy (eg, LCIG, LECIG, CSAI, DBS) at baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in PDQ-8 of Patients with Parkinson’s disease uncontrolled on current oral medication (MANAGE PD category 2 and 3) from baseline visit to month 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| • To describe the demographics, social and clinical characteristics incl. comorbidities of patients in MANAGE PD categories 2 and 3 at baseline • To describe the modification of PD treatment of patients in MANAGE PD categories 2 and 3 throughout the study (including time, reasons for oral modification, reasons for selecting or declining DAT, and medication). • To evaluate the change in Quality of life in the subgroups: (1) patients in category 2, (2) patients in category 3 from baseline to month 12. • To evaluate the changes in activities of daily living and sleep quality in patients in MANAGE PD categories 2 and 3 from baseline to month 12 and 24. • To evaluate changes of motor status (off-time, on-time with dyskinesia, Hoehn & Yahr stage (in On state)) in patients in MANAGE PD categories 2 and 3 from baseline to month 12 and 24. • To describe the transition of patients from MANAGE PD category 2 to category 3 (patients’ demographics and clinical profile) at the time of the switch from category 2 to category 3 • To evaluate patients’ satisfaction with treatment (Treatment Satisfaction Questionnaire for Medication (full 14 item TSQM)) throughout the study (at month 6, month 12, month 18, month 24) and whenever therapy is adjusted/changed Additional objectives – Exploratory: • Description of Patients with changes in PD treatment and without changes in PD treatment of MANAGE PD category 2 as well as Description of patients on DAT therapy and patients still receiving oral therapy but eligible for DAT therapy (MANAGE PD category 3) regarding: o Quality of life o Activities of daily living, o Dyskinesia, Off-time per day (UPDRS IV); no efficacy comparison between device aided therapies will be performed, only side-by-side presentation of descriptive statistics of the group of DAT patients and the group of DAT eligible patients still receiving oral therapy. | — |
Countries
Germany
Contacts
Public ContactArnfin Bergmann
NeuroTransData GmbH
Outcome results
None listed