Parkinson's Disease (PD)BALANCENCT02381444
Health Related Quality of Life in LCIG Patients and LCIG Eligible Patients Continuing Oral Therapy
An observational study of Parkinson's Disease (PD), run by AbbVie at 27 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Parkinson's Disease (PD)
- How many people
- 136 participants
- Where
- 27 sitesin 2 countries
- Study dates
- 17 Apr 2015to 7 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Advanced Parkinson Disease
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
Germany23 sites
Universitaetsklinikum Aachen /ID# 204355
Aachen, North Rhine-Westphalia, 52074
Klinikum Altenburger Land /ID# 139643
Altenburg, 04600
Kliniken Beelitz GmbH /ID# 144633
Beelitz-Heilstätten, 14547
Kupsch, Berlin, DE /ID# 144840
Berlin, 10627
Dr. Puzich, Berlin, DE /ID# 148226
Berlin, 10713
Delf, Berlin-Hoppegarten, DE /ID# 144632
Berlin-hoppengarten, 15366
Central Hospital Bremerhaven /ID# 144639
Bremerhaven, 27574
Uniklinik Koln /ID# 148153
Cologne, North Rhine-Westphalia, 50937
Neuro Centrum Odenwald /ID# 206998
Erbach im Odenwald, 64711
Herbst, Falkensee, DE /ID# 139642
Falkensee, 14612
Universitätsklinikum Freiburg /ID# 144640
Freiburg im Breisgau, 79106
Klinik Haag /ID# 137458
Haag, 83527
KH Martha-Maria Halle Dolau /ID# 144634
Halle, Saxony-Anhalt, 06120
Wellach/Becker, Hamburg, DE /ID# 148228
Hamburg, 22359
Diak.hospital Henriettenstift /ID# 148222
Hanover, 30559
KH Agatharied /ID# 144636
Hausham, 83734
Klinikum Herford AdoeR /ID# 151482
Herford, 32049
Universitatsklinikum Jena_Duplicate /ID# 152813
Jena, 7747
Gertrudis-Klinik /ID# 144631
Leun-biskirchen, 35638
Universitatsklinikum Magdeburg /ID# 163197
Magdeburg, 39120
Philipps-Universitaet Marburg /ID# 116936
Marburg, 35043
Johannes Wesling Klin Minden /ID# 151481
Minden, North Rhine-Westphalia, 32429
Kliniken Berg /ID# 151484
Tübingen, 72076
Switzerland4 sites
Luzerner Kantonsspital /ID# 153738
Lucerne, 6000
Klinik Bethesda /ID# 153739
Tschugg BE, 3233
Rehaklinik Zihlschlacht AG /ID# 153710
Zihlschlacht, 8588
University Hospital Zurich /ID# 153709
Zurich, Canton of Zurich, 8006
About this study
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
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.
Read the 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.
- Conditions
- Parkinson's Disease (PD)
- Keywords
- Advanced Parkinson's Disease, Levodopa Carbidopa Intestinal Gel, Observational Study, Quality of life, Jejunal Percutaneous Endoscopic Gastrostomy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Participants with advanced Parkinson's Disease | |
| Levodopa Carbidopa Intestinal Gel | Participants with advanced Parkinson's Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 12 months
Secondary outcomes (6)
Change in Health Related Quality of Life (HRQL)
Unified Parkinson's disease Rating Scale (UPDRS) part III in the medication "on" state
Measured: At Baseline, 6, and 12 months of treatment
Change in participant's motor symptoms
Activities of daily living "on" and "off" medication - Unified Parkinson's disease Rating Scale (UPDRS) part II
Measured: From Baseline to 6 and 12 months of treatment.
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)
Measured: From Baseline to 6 and 12 months of treatment
Change in participant's non-motor symptoms
Non Motor Symptoms Scale (NMSS) Total score and subdomains Cardiovascular, Sleep/Fatigue, Gastrointestinal, Urinary, Sexual functioning
Measured: From baseline to 6 and 12 months of treatment
Reason for transition to LCIG (or continuing oral therapy)
There are no data comparing long-term HRQL of LCIG versus peroral therapy
Measured: At Baseline, 6 and 12 month
Change in participant's caregiver burden
Non Motor Symptoms Scale (NMSS) Total score and subdomains Cardiovascular, Sleep/Fatigue, Gastrointestinal, Urinary, Sexual functioning
Measured: From Baseline to 6 and 12 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study start17 Apr 2015
- Primary completion7 Jan 2020
- Study completion7 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381444
- Sponsor's protocol ID
- P14-322
- Acronym
- BALANCE
- Status last verified
- Dec 2020
- First submitted
- 3 Mar 2015
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02381444
- Acronym / sponsor ID
- BALANCE / P14-322
- Conditions
- Parkinson's Disease (PD)
- Keywords
- Advanced Parkinson's Disease, Levodopa Carbidopa Intestinal Gel, Observational Study, Quality of life, Jejunal Percutaneous Endoscopic Gastrostomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2015 (actual)
- Primary completion
- 7 Jan 2020 (actual)
- Study completion
- 7 Jan 2020 (actual)
- First posted
- 6 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | – | –Participants with advanced Parkinson's Disease |
| Levodopa Carbidopa Intestinal Gel | – | –Participants with advanced Parkinson's Disease |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced Parkinson Disease
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Change in Health Related Quality of Life (HRQL)
Time frame: 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.
Change in participant's Healthcare Resource Utilization
Time frame: 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
Reason for transition to LCIG (or continuing oral therapy)
Time frame: At Baseline, 6 and 12 month
Change in participant's caregiver burden
Time frame: From Baseline to 6 and 12 months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- clinical study report synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AbbVie Inc. study director
AbbVie
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease (PD), run by AbbVie at 27 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Parkinson's Disease Questionnaire (PDQ-39) summary index (time frame: From baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.