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

Overview

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 Title of Study: “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

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 7, 2020

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.

Arms, Groups and Cohorts

  • Standard of Care
    • Participants with advanced Parkinson’s Disease
  • Levodopa Carbidopa Intestinal Gel
    • Participants with advanced Parkinson’s Disease

Clinical Trial Outcome Measures

Primary Measures

  • Change in the Parkinson’s Disease Questionnaire (PDQ-39) summary index
    • Time Frame: From baseline to 12 months
    • 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.

Secondary Measures

  • Change in Health Related Quality of Life (HRQL)
    • Time Frame: At Baseline, 6, and 12 months of treatment
    • Unified Parkinson’s disease Rating Scale (UPDRS) part III in the medication “on” state
  • Change in participant’s motor symptoms
    • Time Frame: From Baseline to 6 and 12 months of treatment.
    • Activities of daily living “on” and “off” medication – Unified Parkinson’s disease Rating Scale (UPDRS) part II
  • Change in participant’s Healthcare Resource Utilization
    • Time Frame: From Baseline to 6 and 12 months of treatment
    • Frequency and severity of ON-dyskinesia (Unified Parkinson’s Disease Rating Scale part IV, Complications of Therapy: Items 32, 33, 34 and 39)
  • Change in participant’s non-motor symptoms
    • Time Frame: From baseline to 6 and 12 months of treatment
    • Non Motor Symptoms Scale (NMSS) Total score and subdomains Cardiovascular, Sleep/Fatigue, Gastrointestinal, Urinary, Sexual functioning
  • Reason for transition to LCIG (or continuing oral therapy)
    • Time Frame: At Baseline, 6 and 12 month
    • There are no data comparing long-term HRQL of LCIG versus peroral therapy
  • Change in participant’s caregiver burden
    • Time Frame: From Baseline to 6 and 12 months of treatment
    • Non Motor Symptoms Scale (NMSS) Total score and subdomains Cardiovascular, Sleep/Fatigue, Gastrointestinal, Urinary, Sexual functioning

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AbbVie
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • AbbVie Inc., Study Director, AbbVie

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