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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02381444
Other study ID # P14-322
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 17, 2015
Est. completion date January 7, 2020

Study information

Verified date December 2020
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 therapy for Parkinson's Disease.


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.


Recruitment information / eligibility

Status Completed
Enrollment 136
Est. completion date January 7, 2020
Est. primary completion date January 7, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Universitaetsklinikum Aachen /ID# 204355 Aachen Nordrhein-Westfalen
Germany Klinikum Altenburger Land /ID# 139643 Altenburg
Germany Kliniken Beelitz GmbH /ID# 144633 Beelitz-heilstaetten
Germany Dr. Puzich, Berlin, DE /ID# 148226 Berlin
Germany Kupsch, Berlin, DE /ID# 144840 Berlin
Germany Delf, Berlin-Hoppegarten, DE /ID# 144632 Berlin-hoppengarten
Germany Central Hospital Bremerhaven /ID# 144639 Bremerhaven
Germany Neuro Centrum Odenwald /ID# 206998 Erbach
Germany Herbst, Falkensee, DE /ID# 139642 Falkensee
Germany Universitätsklinikum Freiburg /ID# 144640 Freiburg
Germany Klinik Haag /ID# 137458 Haag
Germany KH Martha-Maria Halle Dolau /ID# 144634 Halle (Saale) Sachsen-Anhalt
Germany Wellach/Becker, Hamburg, DE /ID# 148228 Hamburg
Germany Diak.hospital Henriettenstift /ID# 148222 Hannover
Germany KH Agatharied /ID# 144636 Hausham
Germany Klinikum Herford AdoeR /ID# 151482 Herford
Germany Universitatsklinikum Jena_Duplicate /ID# 152813 Jena
Germany Uniklinik Koln /ID# 148153 Köln Nordrhein-Westfalen
Germany Gertrudis-Klinik /ID# 144631 Leun-biskirchen
Germany Universitatsklinikum Magdeburg /ID# 163197 Magdeburg
Germany Philipps-Universitaet Marburg /ID# 116936 Marburg
Germany Johannes Wesling Klin Minden /ID# 151481 Minden Nordrhein-Westfalen
Germany Kliniken Berg /ID# 151484 Tuebingen
Switzerland Luzerner Kantonsspital /ID# 153738 Luzern
Switzerland Klinik Bethesda /ID# 153739 Tschugg BE
Switzerland Rehaklinik Zihlschlacht AG /ID# 153710 Zihlschlacht
Switzerland University Hospital Zurich /ID# 153709 Zurich Zuerich

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in Health Related Quality of Life (HRQL) Unified Parkinson's disease Rating Scale (UPDRS) part III in the medication "on" state At Baseline, 6, and 12 months of treatment
Secondary Change in participant's motor symptoms 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.
Secondary 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) From Baseline to 6 and 12 months of treatment
Secondary Change in participant's non-motor symptoms 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
Secondary Reason for transition to LCIG (or continuing oral therapy) There are no data comparing long-term HRQL of LCIG versus peroral therapy At Baseline, 6 and 12 month
Secondary Change in participant's caregiver burden 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
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