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

NCT ID: NCT02381444

Last Updated: 2020-12-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 136 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-17
• Study Completion Date: 2020-01-07

Brief 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.

Conditions

Parkinson's Disease (PD)

Keywords

Advanced Parkinson's Disease; Levodopa Carbidopa Intestinal Gel; Observational Study; Quality of life; Jejunal Percutaneous Endoscopic Gastrostomy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Standard of Care

Participants with advanced Parkinson's Disease

No interventions assigned to this group

Levodopa Carbidopa Intestinal Gel

Participants with advanced Parkinson's Disease

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

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

Neuro Centrum Odenwald /ID# 206998

Erbach im Odenwald, , Germany

Herbst, Falkensee, DE /ID# 139642

Falkensee, , Germany

Universitätsklinikum Freiburg /ID# 144640

Freiburg im Breisgau, , Germany

Klinik Haag /ID# 137458

Haag, , Germany

Wellach/Becker, Hamburg, DE /ID# 148228

Hamburg, , Germany

Diak.hospital Henriettenstift /ID# 148222

Hanover, , Germany

KH Agatharied /ID# 144636

Hausham, , Germany

Klinikum Herford AdoeR /ID# 151482

Herford, , Germany

Universitatsklinikum Jena_Duplicate /ID# 152813

Jena, , Germany

Gertrudis-Klinik /ID# 144631

Leun-biskirchen, , Germany

Universitatsklinikum Magdeburg /ID# 163197

Magdeburg, , Germany

Philipps-Universitaet Marburg /ID# 116936

Marburg, , Germany

Kliniken Berg /ID# 151484

Tübingen, , Germany

University Hospital Zurich /ID# 153709

Zurich, Canton of Zurich, Switzerland

Luzerner Kantonsspital /ID# 153738

Lucerne, , Switzerland

Klinik Bethesda /ID# 153739

Tschugg BE, , Switzerland

Rehaklinik Zihlschlacht AG /ID# 153710

Zihlschlacht, , Switzerland

Countries

Germany; Switzerland

Related Links

https://www.abbvie.com/content/dam/abbvie-dotcom/clinical-trials/levodopa_carbidopa_P14-322.pdf

clinical study report synopsis

Other Identifiers

P14-322

Identifier Type: -

Identifier Source: org_study_id