Health Related Quality of Life in LCIG Patients and LCIG Eligible Patients Continuing Oral Therapy

Completed

• Conditions: Parkinson's Disease (PD)

• Registration Number: NCT02381444
• Lead Sponsor: AbbVie

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2015-03-03
• Study First Submitted QC: 2015-03-03
• Study First Posted: 2015-03-06
• Study Start: 2015-04-17
• Primary Completion: 2020-01-07
• Study Completion: 2020-01-07
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-07
• Last Update Posted: 2020-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• Eligibility for LCIG according to current version of the Summary of Product Characteristics of LCIG of the respective country (Germany, Switzerland).
• Decision to treat with LCIG or other medication made by the study physician prior to any decision to approach the patient to participate in this study.
• Unchanged available combinations of PD medicinal treatment for at least one week prior to study inclusion.
• Patient has given written informed consent.

Exclusion Criteria

• Contraindication to LCIG according to current version of the German SmPC or Swiss SmPC.
• Contraindication to placement of intrajejunal PEG-J tube.
• Current treatment with Deep Brain Stimulation (DBS), Apomorphine pump or LCIG
• Severe dementia based on a Mini-Mental State Examination (MMSE) of < 10
• Acute psychotic disorder (benign hallucinations or earlier psychotic episodes are not an exclusion criterion)
• Depression with suicidal thoughts (earlier episodes of major depression are not an exclusion criterion)
• History or presence of any condition that might interfere with absorption, distribution, metabolism, or excretion of LCIG
• Drug or alcohol addiction (drug addiction: continuous or sporadic use of drugs without medical indication or with paradoxical medical indication or in inappropriate amounts. Addictive consumption of e.g. alcohol, cannabis, amphetamine, sniffing agents, cocaine, heroin, crack). Alcohol addiction male: > 40 g/day; female: > 30 g/day)
• Illiteracy or insufficient language skills to complete the questionnaires

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the Parkinson's Disease Questionnaire (PDQ-39) summary index	From baseline to 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Health Related Quality of Life (HRQL)	At Baseline, 6, and 12 months of treatment	Unified Parkinson's disease Rating Scale (UPDRS) part III in the medication "on" state
Change in participant's non-motor symptoms	From baseline to 6 and 12 months of treatment	Non Motor Symptoms Scale (NMSS) Total score and subdomains Cardiovascular, Sleep/Fatigue, Gastrointestinal, Urinary, Sexual functioning
Reason for transition to LCIG (or continuing oral therapy)	At Baseline, 6 and 12 month	There are no data comparing long-term HRQL of LCIG versus peroral therapy
Change in participant's motor symptoms	From Baseline to 6 and 12 months of treatment.	Activities of daily living "on" and "off" medication - Unified Parkinson's disease Rating Scale (UPDRS) part II
Change in participant's Healthcare Resource Utilization	From Baseline to 6 and 12 months of treatment	Frequency and severity of ON-dyskinesia (Unified Parkinson's Disease Rating Scale part IV, Complications of Therapy: Items 32, 33, 34 and 39)
Change in participant's caregiver burden	From Baseline to 6 and 12 months of treatment	Non Motor Symptoms Scale (NMSS) Total score and subdomains Cardiovascular, Sleep/Fatigue, Gastrointestinal, Urinary, Sexual functioning

Trial Locations

Locations (27)

Gertrudis-Klinik /ID# 144631; 🇩🇪 Leun-biskirchen, Germany

Klinikum Altenburger Land /ID# 139643; 🇩🇪 Altenburg, Germany

Klinik Haag /ID# 137458; 🇩🇪 Haag, Germany

Universitaetsklinikum Aachen /ID# 204355; 🇩🇪 Aachen, Nordrhein-Westfalen, Germany

Johannes Wesling Klin Minden /ID# 151481; 🇩🇪 Minden, Nordrhein-Westfalen, Germany

Uniklinik Koln /ID# 148153; 🇩🇪 Köln, Nordrhein-Westfalen, Germany

KH Martha-Maria Halle Dolau /ID# 144634; 🇩🇪 Halle (Saale), Sachsen-Anhalt, Germany

Kliniken Beelitz GmbH /ID# 144633; 🇩🇪 Beelitz-heilstaetten, Germany

Delf, Berlin-Hoppegarten, DE /ID# 144632; 🇩🇪 Berlin-hoppengarten, Germany

Kupsch, Berlin, DE /ID# 144840; 🇩🇪 Berlin, Germany

Dr. Puzich, Berlin, DE /ID# 148226; 🇩🇪 Berlin, Germany

Neuro Centrum Odenwald /ID# 206998; 🇩🇪 Erbach, Germany

Herbst, Falkensee, DE /ID# 139642; 🇩🇪 Falkensee, Germany

Wellach/Becker, Hamburg, DE /ID# 148228; 🇩🇪 Hamburg, Germany

Diak.hospital Henriettenstift /ID# 148222; 🇩🇪 Hannover, Germany

Klinikum Herford AdoeR /ID# 151482; 🇩🇪 Herford, Germany

Universitatsklinikum Jena_Duplicate /ID# 152813; 🇩🇪 Jena, Germany

Universitatsklinikum Magdeburg /ID# 163197; 🇩🇪 Magdeburg, Germany

Philipps-Universitaet Marburg /ID# 116936; 🇩🇪 Marburg, Germany

Kliniken Berg /ID# 151484; 🇩🇪 Tuebingen, Germany

Rehaklinik Zihlschlacht AG /ID# 153710; 🇨🇭 Zihlschlacht, Switzerland

Luzerner Kantonsspital /ID# 153738; 🇨🇭 Luzern, Switzerland

University Hospital Zurich /ID# 153709; 🇨🇭 Zurich, Zuerich, Switzerland

Klinik Bethesda /ID# 153739; 🇨🇭 Tschugg BE, Switzerland

Central Hospital Bremerhaven /ID# 144639; 🇩🇪 Bremerhaven, Germany

Universitätsklinikum Freiburg /ID# 144640; 🇩🇪 Freiburg, Germany

KH Agatharied /ID# 144636; 🇩🇪 Hausham, Germany