The aim of this study is to assess the effect of LCIG (levodopa-carbidopa intestinal gel) on HRQL (Health-Related Quality of Life) of participants and compare the Health-Related Quality of Life between participants continuing to levodopa-carbidopa intestinal gel treatments versus participants continuing on oral therapy for Parkinson's Disease.
Parkinson's disease (PD) is the second most common neurodegenerative disorder in the world. It can be treated sufficiently until motor complications with fluctuations of mobility and dyskinesia develop. The quality of life is relentlessly deteriorating with longer disease duration once the complications of conservative oral therapy develop. Continuous dopaminergic stimulation using Levodopa/Carbidopa Intestinal Gel (LCIG) improves the motor complications of Parkinson's disease and preliminary data suggest that also the quality of life is improved. Primary Objective is to assess the effect of LCIG on Health Related Quality of Life (HRQL) of patients according to selection criteria from German guidelines and compare improvement in HRQL between patients continuing to LCIG treatment and patients staying on oral treatment, despite being eligible according to these guidelines. In addition, current selection criteria recommended by the national guideline will be documented at baseline.
Study Type
OBSERVATIONAL
Enrollment
136
Change in the Parkinson's Disease Questionnaire (PDQ-39) summary index
The primary endpoint is the change in the Parkinson's Disease Questionnaire (PDQ-39) summary index from 12 months to the baseline assessment. The two treatment groups levodopa-carbidopa intestinal gel vs. Standard of Care will be compared.
Time frame: From baseline to 12 months
Change in Health Related Quality of Life (HRQL)
Unified Parkinson's disease Rating Scale (UPDRS) part III in the medication "on" state
Time frame: At Baseline, 6, and 12 months of treatment
Change in participant's motor symptoms
Activities of daily living "on" and "off" medication - Unified Parkinson's disease Rating Scale (UPDRS) part II
Time frame: From Baseline to 6 and 12 months of treatment.
Change in participant's Healthcare Resource Utilization
Frequency and severity of ON-dyskinesia (Unified Parkinson's Disease Rating Scale part IV, Complications of Therapy: Items 32, 33, 34 and 39)
Time frame: From Baseline to 6 and 12 months of treatment
Change in participant's non-motor symptoms
Non Motor Symptoms Scale (NMSS) Total score and subdomains Cardiovascular, Sleep/Fatigue, Gastrointestinal, Urinary, Sexual functioning
Time frame: From baseline to 6 and 12 months of treatment
Reason for transition to LCIG (or continuing oral therapy)
There are no data comparing long-term HRQL of LCIG versus peroral therapy
Time frame: At Baseline, 6 and 12 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Universitaetsklinikum Aachen /ID# 204355
Aachen, North Rhine-Westphalia, Germany
Uniklinik Koln /ID# 148153
Cologne, North Rhine-Westphalia, Germany
Johannes Wesling Klin Minden /ID# 151481
Minden, North Rhine-Westphalia, Germany
KH Martha-Maria Halle Dolau /ID# 144634
Halle, Saxony-Anhalt, Germany
Klinikum Altenburger Land /ID# 139643
Altenburg, Germany
Kliniken Beelitz GmbH /ID# 144633
Beelitz-Heilstätten, Germany
Kupsch, Berlin, DE /ID# 144840
Berlin, Germany
Dr. Puzich, Berlin, DE /ID# 148226
Berlin, Germany
Delf, Berlin-Hoppegarten, DE /ID# 144632
Berlin-hoppengarten, Germany
Central Hospital Bremerhaven /ID# 144639
Bremerhaven, Germany
...and 17 more locations
Change in participant's caregiver burden
Non Motor Symptoms Scale (NMSS) Total score and subdomains Cardiovascular, Sleep/Fatigue, Gastrointestinal, Urinary, Sexual functioning
Time frame: From Baseline to 6 and 12 months of treatment