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Health Related Quality of Life in LCIG Patients and LCIG Eligible Patients Continuing Oral Therapy | Clinical Trials | Clareo Health

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

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

NCT02381444•AbbVie

View on ClinicalTrials.gov

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

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

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

Locations (27)

Universitaetsklinikum Aachen /ID# 204355

Aachen, North Rhine-Westphalia, Germany

Uniklinik Koln /ID# 148153

Cologne, North Rhine-Westphalia, Germany

Johannes Wesling Klin Minden /ID# 151481

Minden, North Rhine-Westphalia, Germany

KH Martha-Maria Halle Dolau /ID# 144634

Halle, Saxony-Anhalt, Germany

Klinikum Altenburger Land /ID# 139643

Altenburg, Germany

Kliniken Beelitz GmbH /ID# 144633

Beelitz-Heilstätten, Germany

Kupsch, Berlin, DE /ID# 144840

Berlin, Germany

Dr. Puzich, Berlin, DE /ID# 148226

Berlin, Germany

Delf, Berlin-Hoppegarten, DE /ID# 144632

Berlin-hoppengarten, Germany

Central Hospital Bremerhaven /ID# 144639

Bremerhaven, Germany

Key Dates

Start Date

April 17, 2015

Primary Completion Date

January 7, 2020

Completion Date

January 7, 2020

Last Updated

December 9, 2020

Enrollment

136

ACTUAL participants

Conditions

Parkinson's Disease (PD)

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

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Healthy Volunteers (HV)Parkinson's Disease (PD)

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RECRUITINGNA

LIFUS For Neurological Disorders

NCT07417280

Parkinson's Disease (PD)Essential Tremor+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 9, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

LIFUS For Neurological Disorders

Real-World Study of ABBV-951 Subcutaneous Infusion to Assess Change in Disease Activity in Adult Participants With Parkinson's Disease

A Phase 2 Study to Assess the Effects of SUL-238 on High Energy Phosphates With ³¹P-MRS in Patients With Early, Untreated Parkinson's Disease

Novel DBS Device in Parkinson's Disease

A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)