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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Participants with advanced Parkinson's Disease | ||
| Levodopa Carbidopa Intestinal Gel | Participants with advanced Parkinson's Disease |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Health Related Quality of Life (HRQL) | Unified Parkinson's disease Rating Scale (UPDRS) part III in the medication "on" state | At Baseline, 6, and 12 months of treatment |
| Change in participant's motor symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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Advanced Parkinson Disease
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaetsklinikum Aachen /ID# 204355 | Aachen | North Rhine-Westphalia | 52074 | Germany | ||
| Uniklinik Koln /ID# 148153 |
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| Label | URL |
|---|---|
| clinical study report synopsis | View source |
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Activities of daily living "on" and "off" medication - Unified Parkinson's disease Rating Scale (UPDRS) part II
| 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) | 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 | 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 | At Baseline, 6 and 12 month |
| Change in participant's caregiver burden | Non Motor Symptoms Scale (NMSS) Total score and subdomains Cardiovascular, Sleep/Fatigue, Gastrointestinal, Urinary, Sexual functioning | From Baseline to 6 and 12 months of treatment |
| Cologne |
| North Rhine-Westphalia |
| 50937 |
| Germany |
| Johannes Wesling Klin Minden /ID# 151481 | Minden | North Rhine-Westphalia | 32429 | Germany |
| KH Martha-Maria Halle Dolau /ID# 144634 | Halle | Saxony-Anhalt | 06120 | Germany |
| Klinikum Altenburger Land /ID# 139643 | Altenburg | 04600 | Germany |
| Kliniken Beelitz GmbH /ID# 144633 | Beelitz-Heilstätten | 14547 | Germany |
| Kupsch, Berlin, DE /ID# 144840 | Berlin | 10627 | Germany |
| Dr. Puzich, Berlin, DE /ID# 148226 | Berlin | 10713 | Germany |
| Delf, Berlin-Hoppegarten, DE /ID# 144632 | Berlin-hoppengarten | 15366 | Germany |
| Central Hospital Bremerhaven /ID# 144639 | Bremerhaven | 27574 | Germany |
| Neuro Centrum Odenwald /ID# 206998 | Erbach im Odenwald | 64711 | Germany |
| Herbst, Falkensee, DE /ID# 139642 | Falkensee | 14612 | Germany |
| Universitätsklinikum Freiburg /ID# 144640 | Freiburg im Breisgau | 79106 | Germany |
| Klinik Haag /ID# 137458 | Haag | 83527 | Germany |
| Wellach/Becker, Hamburg, DE /ID# 148228 | Hamburg | 22359 | Germany |
| Diak.hospital Henriettenstift /ID# 148222 | Hanover | 30559 | Germany |
| KH Agatharied /ID# 144636 | Hausham | 83734 | Germany |
| Klinikum Herford AdoeR /ID# 151482 | Herford | 32049 | Germany |
| Universitatsklinikum Jena_Duplicate /ID# 152813 | Jena | 7747 | Germany |
| Gertrudis-Klinik /ID# 144631 | Leun-biskirchen | 35638 | Germany |
| Universitatsklinikum Magdeburg /ID# 163197 | Magdeburg | 39120 | Germany |
| Philipps-Universitaet Marburg /ID# 116936 | Marburg | 35043 | Germany |
| Kliniken Berg /ID# 151484 | Tübingen | 72076 | Germany |
| University Hospital Zurich /ID# 153709 | Zurich | Canton of Zurich | 8006 | Switzerland |
| Luzerner Kantonsspital /ID# 153738 | Lucerne | 6000 | Switzerland |
| Klinik Bethesda /ID# 153739 | Tschugg BE | 3233 | Switzerland |
| Rehaklinik Zihlschlacht AG /ID# 153710 | Zihlschlacht | 8588 | Switzerland |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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