PARKINSONASSOZIIERTERSCHMERZ G20
Conditions
Interventions
Group 1: The observation will be performed in patients who suffer from idiopathic Parkinson's disease stage 1-5 according to Hoehn & Yahr and who suffer from severe Parkinson-associated pain which can
Sponsors
Mundipharma GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Male and female patients aged = 18 years. • patients who suffer from diopathic Parkinson's disease stage 1-5 according to Hoehn & Yahr. • patients who suffer from severe pain graded in at least 1 question of 1 domain of the King’s Parkinson’s disease pain scale (KPPS) which can, according to the physicians opinion, only adequately be managed with opioid analgesics, • patients without contraindication (s) for treatment with Targin® according to summary of product characteristics (SmPC) • patients who are not cognitively impaired and able to understand the purpose and importance of the study and complete the questionnaire. • patients who were not treated with opioid analgesics within the last 3 months before enrolment • patients who give their written consent for study participation and for data privacy policy
Exclusion criteria
Exclusion criteria: The Observation should not be performed in pregnant women or nursing women as well as women willing to become pregnant during treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objectives of main interest: • Efficacy of Targin® on Parkinson’s disease associated pain intensity assessed using the numeric rating scale (NRS) for clinical pain measurement. Pain on average scores (item 5 of the Brief Pain Inventory Short Form [BPI-SF]) will be compared between baseline and the control visit after 8-12 weeks of treatment. • Responder rate: Percentage of patients with = 30% reduction in average pain score of NRS between baseline and the control visit after 8-12 weeks under treatment with Targin®. • Characterization of patient population: King’s Parkinson’s disease pain scale (KPPS) to identify and grade the various types of pain in Parkinson’s disease at baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of Targin® on the following parameters (values will be compared between baseline and the control visit): • Efficacy of Targin® on PD-associated pain severity calculated from the 4 pain severity items (pain at worst, pain at least, pain on average, pain right now) assessed by the BPI-SF with an 11-point NRS for each item. • Efficacy of Targin® on pain relief experienced by the patient within the last 24 hours assessed by BPI-SF item 8. • Efficacy of Targin® on severity and frequency of various types of pain assessed by KPPS. Scores of the different pain domains will be compared between baseline and the control visit after 8-12 weeks of treatment. • Efficacy of Targin® on patient’s daily activity assessed by item 9 of the BPI-SF and on quality of life assessed with the Parkinson’s Disease Questionnaire (PDQ-8). • Influence of Targin® on motor symptoms documented by the Unified Parkinson’s Disease Rating Scale (UPDRS) Part III: Motor examination. • Influence of Targin® on non-motor symptoms assessed by the Non-Motor Symptoms assessment scale for Parkinson’s disease (NMSScale). • Influence of Targin® on quality of sleep documented by Parkinson’s disease sleep scale (PDSS-2). Tolerance of Targin® will be conducted based on the following parameters: • Number, intensity and severity of adverse events as well as number and frequency of affected patients • Assessment of tolerance by the physician after 8 - 12 weeks of treatment | — |
Countries
Germany
Contacts
Public ContactSandra Höpfert
ANFOMED GmbH
Outcome results
None listed