Targin® for Treatment of Parkinson's disease associated severe pain - Efficacy and tolerability in real life
- Conditions
- PARKINSONASSOZIIERTERSCHMERZG20Parkinson disease
- Registration Number
- DRKS00010280
- Lead Sponsor
- Mundipharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
• 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
The Observation should not be performed in pregnant women or nursing women as well as women willing to become pregnant during treatment.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objectives of main interest: <br>• 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. <br>• 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®.<br>• 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.<br>
- Secondary Outcome Measures
Name Time Method