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

Parkinson's Disease (PD) Clinical Trial

— BALANCE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02381444
• Other study ID #: P14-322
• Status: Completed
• Start date: April 17, 2015
• Est. completion date: January 7, 2020

Study information

• Verified date: December 2020
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: January 7, 2020
• Est. primary completion date: January 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease (PD)

Locations

Country	Name	City	State
Germany	Universitaetsklinikum Aachen /ID# 204355	Aachen	Nordrhein-Westfalen
Germany	Klinikum Altenburger Land /ID# 139643	Altenburg
Germany	Kliniken Beelitz GmbH /ID# 144633	Beelitz-heilstaetten
Germany	Dr. Puzich, Berlin, DE /ID# 148226	Berlin
Germany	Kupsch, Berlin, DE /ID# 144840	Berlin
Germany	Delf, Berlin-Hoppegarten, DE /ID# 144632	Berlin-hoppengarten
Germany	Central Hospital Bremerhaven /ID# 144639	Bremerhaven
Germany	Neuro Centrum Odenwald /ID# 206998	Erbach
Germany	Herbst, Falkensee, DE /ID# 139642	Falkensee
Germany	Universitätsklinikum Freiburg /ID# 144640	Freiburg
Germany	Klinik Haag /ID# 137458	Haag
Germany	KH Martha-Maria Halle Dolau /ID# 144634	Halle (Saale)	Sachsen-Anhalt
Germany	Wellach/Becker, Hamburg, DE /ID# 148228	Hamburg
Germany	Diak.hospital Henriettenstift /ID# 148222	Hannover
Germany	KH Agatharied /ID# 144636	Hausham
Germany	Klinikum Herford AdoeR /ID# 151482	Herford
Germany	Universitatsklinikum Jena_Duplicate /ID# 152813	Jena
Germany	Uniklinik Koln /ID# 148153	Köln	Nordrhein-Westfalen
Germany	Gertrudis-Klinik /ID# 144631	Leun-biskirchen
Germany	Universitatsklinikum Magdeburg /ID# 163197	Magdeburg
Germany	Philipps-Universitaet Marburg /ID# 116936	Marburg
Germany	Johannes Wesling Klin Minden /ID# 151481	Minden	Nordrhein-Westfalen
Germany	Kliniken Berg /ID# 151484	Tuebingen
Switzerland	Luzerner Kantonsspital /ID# 153738	Luzern
Switzerland	Klinik Bethesda /ID# 153739	Tschugg BE
Switzerland	Rehaklinik Zihlschlacht AG /ID# 153710	Zihlschlacht
Switzerland	University Hospital Zurich /ID# 153709	Zurich	Zuerich

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   clinical study report synopsis