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

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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease (PD)

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 Type: Observational
• Enrollment (Actual): 136

Contacts and Locations

Study Locations

• Germany
  • Altenburg, Germany, 04600
    • Klinikum Altenburger Land /ID# 139643
  • Beelitz-heilstaetten, Germany, 14547
    • Kliniken Beelitz GmbH /ID# 144633
  • Berlin, Germany, 10627
    • Kupsch, Berlin, DE /ID# 144840
  • Berlin, Germany, 10713
    • Dr. Puzich, Berlin, DE /ID# 148226
  • Berlin-hoppengarten, Germany, 15366
    • Delf, Berlin-Hoppegarten, DE /ID# 144632
  • Bremerhaven, Germany, 27574
    • Central Hospital Bremerhaven /ID# 144639
  • Erbach, Germany, 64711
    • Neuro Centrum Odenwald /ID# 206998
  • Falkensee, Germany, 14612
    • Herbst, Falkensee, DE /ID# 139642
  • Freiburg, Germany, 79106
    • Universitätsklinikum Freiburg /ID# 144640
  • Haag, Germany, 83527
    • Klinik Haag /ID# 137458
  • Hamburg, Germany, 22359
    • Wellach/Becker, Hamburg, DE /ID# 148228
  • Hannover, Germany, 30559
    • Diak.hospital Henriettenstift /ID# 148222
  • Hausham, Germany, 83734
    • KH Agatharied /ID# 144636
  • Herford, Germany, 32049
    • Klinikum Herford AdoeR /ID# 151482
  • Jena, Germany, 7747
    • Universitatsklinikum Jena_Duplicate /ID# 152813
  • Leun-biskirchen, Germany, 35638
    • Gertrudis-Klinik /ID# 144631
  • Magdeburg, Germany, 39120
    • Universitatsklinikum Magdeburg /ID# 163197
  • Marburg, Germany, 35043
    • Philipps-Universitaet Marburg /ID# 116936
  • Tuebingen, Germany, 72076
    • Kliniken Berg /ID# 151484
  • Nordrhein-Westfalen
    • Aachen, Nordrhein-Westfalen, Germany, 52074
      • Universitaetsklinikum Aachen /ID# 204355
    • Köln, Nordrhein-Westfalen, Germany, 50937
      • Uniklinik Koln /ID# 148153
    • Minden, Nordrhein-Westfalen, Germany, 32429
      • Johannes Wesling Klin Minden /ID# 151481
  • Sachsen-Anhalt
    • Halle (Saale), Sachsen-Anhalt, Germany, 06120
      • KH Martha-Maria Halle Dolau /ID# 144634
• Switzerland
  • Luzern, Switzerland, 6000
    • Luzerner Kantonsspital /ID# 153738
  • Tschugg BE, Switzerland, 3233
    • Klinik Bethesda /ID# 153739
  • Zihlschlacht, Switzerland, 8588
    • Rehaklinik Zihlschlacht AG /ID# 153710
  • Zuerich
    • Zurich, Zuerich, Switzerland, 8006
      • University Hospital Zurich /ID# 153709

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Advanced Parkinson Disease

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Standard of Care; Participants with advanced Parkinson's Disease
Levodopa Carbidopa Intestinal Gel; Participants with advanced Parkinson's Disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2015
• Primary Completion (Actual): January 7, 2020
• Study Completion (Actual): January 7, 2020

Study Registration Dates

• First Submitted: March 3, 2015
• First Submitted That Met QC Criteria: March 3, 2015
• First Posted (Estimate): March 6, 2015

Study Record Updates

• Last Update Posted (Actual): December 9, 2020
• Last Update Submitted That Met QC Criteria: December 7, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Quality of life; Observational Study; Advanced Parkinson's Disease; Levodopa Carbidopa Intestinal Gel; Jejunal Percutaneous Endoscopic Gastrostomy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: P14-322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No