Clinical trial NCT02381444: Health Related Quality of Life in LCIG Patients and LCIG Eligible Patients Continuing Oral Therapy
Official title: Health Related Quality of Life in LCIG Patients and LCIG Patients and LCIG Eligible Patients Continuing Oral Therapy. A Multicenter Post Marketing Observational Study for LCIG in Germany and Switzerland - BALANCE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease (PD)
Keywords: Advanced Parkinson's Disease
Levodopa Carbidopa Intestinal Gel
Observational Study
Quality of life
Jejunal Percutaneous Endoscopic Gastrostomy
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-03-06
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Advanced Parkinson Disease

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the Parkinson's Disease Questionnaire (PDQ-39) summary index
timeFrame: From baseline to 12 months
Secondary outcomes:
measure: Change in Health Related Quality of Life (HRQL)
timeFrame: At Baseline, 6, and 12 months of treatment
measure: Change in participant's motor symptoms
timeFrame: From Baseline to 6 and 12 months of treatment.
measure: Change in participant's Healthcare Resource Utilization
timeFrame: From Baseline to 6 and 12 months of treatment
measure: Change in participant's non-motor symptoms
timeFrame: From baseline to 6 and 12 months of treatment
measure: Reason for transition to LCIG (or continuing oral therapy)
timeFrame: At Baseline, 6 and 12 month
measure: Change in participant's caregiver burden
timeFrame: From Baseline to 6 and 12 months of treatment
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universitaetsklinikum Aachen /ID# 204355
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Uniklinik Koln /ID# 148153
state: Nordrhein-Westfalen
city: Minden
country: Germany
facility: Johannes Wesling Klin Minden /ID# 151481
state: Nordrhein-Westfalen
city: Halle (Saale)
country: Germany
facility: KH Martha-Maria Halle Dolau /ID# 144634
state: Sachsen-Anhalt
city: Altenburg
country: Germany
facility: Klinikum Altenburger Land /ID# 139643
city: Beelitz-heilstaetten
country: Germany
facility: Kliniken Beelitz GmbH /ID# 144633
city: Berlin-hoppengarten
country: Germany
facility: Delf, Berlin-Hoppegarten, DE /ID# 144632
city: Berlin
country: Germany
facility: Kupsch, Berlin, DE /ID# 144840
city: Berlin
country: Germany
facility: Dr. Puzich, Berlin, DE /ID# 148226
city: Bremerhaven
country: Germany
facility: Central Hospital Bremerhaven /ID# 144639
city: Erbach
country: Germany
facility: Neuro Centrum Odenwald /ID# 206998
city: Falkensee
country: Germany
facility: Herbst, Falkensee, DE /ID# 139642
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg /ID# 144640
city: Haag
country: Germany
facility: Klinik Haag /ID# 137458
city: Hamburg
country: Germany
facility: Wellach/Becker, Hamburg, DE /ID# 148228
city: Hannover
country: Germany
facility: Diak.hospital Henriettenstift /ID# 148222
city: Hausham
country: Germany
facility: KH Agatharied /ID# 144636
city: Herford
country: Germany
facility: Klinikum Herford AdoeR /ID# 151482
city: Jena
country: Germany
facility: Universitatsklinikum Jena_Duplicate /ID# 152813
city: Leun-biskirchen
country: Germany
facility: Gertrudis-Klinik /ID# 144631
city: Magdeburg
country: Germany
facility: Universitatsklinikum Magdeburg /ID# 163197
city: Marburg
country: Germany
facility: Philipps-Universitaet Marburg /ID# 116936
city: Tuebingen
country: Germany
facility: Kliniken Berg /ID# 151484
city: Zurich
country: Switzerland
facility: University Hospital Zurich /ID# 153709
state: Zuerich
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital /ID# 153738
city: Tschugg BE
country: Switzerland
facility: Klinik Bethesda /ID# 153739
city: Zihlschlacht
country: Switzerland
facility: Rehaklinik Zihlschlacht AG /ID# 153710
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: