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

December 7, 2020 updated by: AbbVie

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
136

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From baseline to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
At Baseline, 6, and 12 months of treatment
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
From Baseline to 6 and 12 months of treatment.
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)
From Baseline to 6 and 12 months of treatment
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
From baseline to 6 and 12 months of treatment
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
At Baseline, 6 and 12 month
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
From Baseline to 6 and 12 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 17, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 7, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 7, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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