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

AbbVie

Status

Completed

Conditions

Parkinson's Disease (PD)

Study type

Observational

Funder types

Industry

Identifiers

NCT02381444

P14-322

Details and patient eligibility

About

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.

Full 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.

Enrollment

136 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No 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