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

NCT02381444 | Completed

• 1 other identifier: P14-322
• Study Type: observational
• Target: 136
• Locations: 2 countries
• Sites: 27

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.

Conditions

Parkinson's Disease (PD)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to 12 months

Secondary Outcomes (6)

• Change in Health Related Quality of Life (HRQL)

  At Baseline, 6, and 12 months of treatment

• Change in participant's motor symptoms

  From Baseline to 6 and 12 months of treatment.

• Change in participant's Healthcare Resource Utilization

  From Baseline to 6 and 12 months of treatment

• Change in participant's non-motor symptoms

  From baseline to 6 and 12 months of treatment

• Reason for transition to LCIG (or continuing oral therapy)

  At Baseline, 6 and 12 month

Study Arms (2)

Standard of Care

Participants with advanced Parkinson's Disease

Levodopa Carbidopa Intestinal Gel

Participants with advanced Parkinson's Disease

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Advanced Parkinson Disease

You may qualify if:

• 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.
• Patient has given written informed consent.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (27)

Universitaetsklinikum Aachen /ID# 204355

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Uniklinik Koln /ID# 148153

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Johannes Wesling Klin Minden /ID# 151481

Minden, North Rhine-Westphalia, 32429, Germany

Location

KH Martha-Maria Halle Dolau /ID# 144634

Halle, Saxony-Anhalt, 06120, Germany

Location

Klinikum Altenburger Land /ID# 139643

Altenburg, 04600, Germany

Location

Kliniken Beelitz GmbH /ID# 144633

Beelitz-Heilstätten, 14547, Germany

Location

Kupsch, Berlin, DE /ID# 144840

Berlin, 10627, Germany

Location

Dr. Puzich, Berlin, DE /ID# 148226

Berlin, 10713, Germany

Location

Delf, Berlin-Hoppegarten, DE /ID# 144632

Berlin-hoppengarten, 15366, Germany

Location

Central Hospital Bremerhaven /ID# 144639

Bremerhaven, 27574, Germany

Location

Neuro Centrum Odenwald /ID# 206998

Erbach im Odenwald, 64711, Germany

Location

Herbst, Falkensee, DE /ID# 139642

Falkensee, 14612, Germany

Location

Universitätsklinikum Freiburg /ID# 144640

Freiburg im Breisgau, 79106, Germany

Location

Klinik Haag /ID# 137458

Haag, 83527, Germany

Location

Wellach/Becker, Hamburg, DE /ID# 148228

Hamburg, 22359, Germany

Location

Diak.hospital Henriettenstift /ID# 148222

Hanover, 30559, Germany

Location

KH Agatharied /ID# 144636

Hausham, 83734, Germany

Location

Klinikum Herford AdoeR /ID# 151482

Herford, 32049, Germany

Location

Universitatsklinikum Jena_Duplicate /ID# 152813

Jena, 7747, Germany

Location

Gertrudis-Klinik /ID# 144631

Leun-biskirchen, 35638, Germany

Location

Universitatsklinikum Magdeburg /ID# 163197

Magdeburg, 39120, Germany

Location

Philipps-Universitaet Marburg /ID# 116936

Marburg, 35043, Germany

Location

Kliniken Berg /ID# 151484

Tübingen, 72076, Germany

Location

University Hospital Zurich /ID# 153709

Zurich, Canton of Zurich, 8006, Switzerland

Location

Luzerner Kantonsspital /ID# 153738

Lucerne, 6000, Switzerland

Location

Klinik Bethesda /ID# 153739

Tschugg BE, 3233, Switzerland

Location

Rehaklinik Zihlschlacht AG /ID# 153710

Zihlschlacht, 8588, Switzerland

Location

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: March 6, 2015
• Study Start: April 17, 2015
• Primary Completion: January 7, 2020
• Study Completion: January 7, 2020
• Last Updated: December 9, 2020

Record last verified: 2020-12

Locations

DE (23); CH (4)