Global REsponsE During iNFusIon of a gEl With LevoDopa/Carbidopa (GREENFIELD)

This study is currently recruiting participants.
Verified January 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01754129
First received: December 18, 2012
Last updated: January 5, 2014
Last verified: January 2014
  Purpose

In patients with advanced levodopa-responsive Parkinson's Disease and severe motor fluctuations despite optimized treatment with conventional oral Parkinson's Disease medications, treatment with Duodopa represents an alternative treatment option to improve motor, non-motor performance and overall quality of life. These benefits have been obtained in short and mid-term trials (mainly up to 2 years). Data on long-term effectiveness (5 years of treatment or more) and safety are not available. Also data concerning the benefit of Duodopa on cognitive function, axial symptoms and disability have to be confirmed. Recent data on deep brain stimulation (DBS), the alternative option treatment in advanced Parkinson's Disease patients, showed that after 5 years from the implant, a worsening of axial symptoms (gait and balance) and after 1 to 3 years of speech could occur. Moreover, it has never been assessed if the benefit on motor and non-motor symptoms in patients treated with DUODOPA could be influenced by age and duration of the disease, as already shown for DBS implanted patients. This study should clarify the missing information on long-term benefit of Duodopa (up to 7 years) especially focusing on motor fluctuations and disability.


Condition
Parkinson's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Global REsponsE During iNFusIon of a gEl With LevoDopa/Carbidopa (GREENFIELD)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Change in Unified Parkinson Disease Rating Scale (UPDRS) IV - item 39 (proportion of waking day spent in "OFF") [ Time Frame: From Day 0 to month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Unified Parkinson's disease rating scale on complications of therapy (UPDRS IV) [ Time Frame: From Day 0 to month 24 ] [ Designated as safety issue: No ]
  • Change in Unified Parkinson's disease rating scale on Mentation, Behavior and Mood (UPDRS I), on Activities of Daily Living (UPDRS II) for both in OFF and in ON phase. [ Time Frame: From Day 0 to month 24 ] [ Designated as safety issue: No ]
  • Change in Parkinson Disease Quality of Life Questionnaire in 39 items (PDQ 39) [ Time Frame: From Day 0 to month 24 ] [ Designated as safety issue: No ]
  • Change in Parkinson Disease Sleep Scale version 2 (PDSS-2) [ Time Frame: From Day 0 to month 24 ] [ Designated as safety issue: No ]
  • Change in Gait and Fall Questionnaire [ Time Frame: From Day 0 to month 24 ] [ Designated as safety issue: No ]
  • Change in Questionnaire for Impulsive -Compulsive Disorders in Parkinsons' Disease (QUIP-RS) [ Time Frame: From Day 0 to month 24 ] [ Designated as safety issue: No ]
  • Change in Economical and social impact of the familiar healthcare [ Time Frame: From Day 0 to month 24 ] [ Designated as safety issue: No ]
  • Change in Relative Stress Scale questionnaire (RSS) [ Time Frame: From Day 0 to month 24 ] [ Designated as safety issue: No ]
  • Change in Concomitant diseases and therapies [ Time Frame: From Day 0 to month 24 ] [ Designated as safety issue: No ]
  • Change in Global efficacy on motor symptoms rated by neurologists vs baseline on a three-point scale: improvement, no change, worsening [ Time Frame: From Day 0 to month 24 ] [ Designated as safety issue: No ]
  • Change in Self-assessment patients scale regarding their judgement on Duodopa therapy, rated from 0 to 10 and assessed as follows: 0-2: worse, 3-5 unsatisfactory, 6-8 satisfactory, 9-10 very good [ Time Frame: From Day 0 to month 24 ] [ Designated as safety issue: No ]
  • Change in Duodopa daily infusion dosage [ Time Frame: From Day 0 to month 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: December 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Parkinson's Disease patient
Patients with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who are prescribed and treated in accordance with local DUODOPA® product label under the conditions of a routine clinical setting.

Detailed Description:

Post Marketing Observational Study to document the long-term clinical effectiveness of DUODOPA in Parkinson Disease patients under the conditions of a routine clinical setting.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients already on treatment with DUODOPA® according local DUODOPA® product label (treatment of advanced levodopa-responsive Parkinson's disease with severe motor fluctuations and hyper/dyskinesia when available combinations of PD medicinal products have not given satisfactory results) and according to specific reimbursement criteria will be offered the opportunity to enroll in this study.

Criteria

Inclusion Criteria:

  • Patients already on treatment with DUODOPA ® (having already concluded the naso-intestinal phase) according to the local DUODOPA® product label and to clinical routine care for advanced PD patients
  • Patients with available data on Duodopa treatment, on previous PD conventional treatments and with at least one of the scales/questionnaires under study already collected on the patient clinical chart
  • Patient or legal representative has given written informed consent
  • Non-professional caregiver (relative or familiar who give daily assistance to the patient) has given his/her written consent

Exclusion Criteria:

• History or presence of any condition that might interfere with the long-term continuation of the duodenal infusion of DUODOPA

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01754129

Contacts
Contact: Raffaella Mancini 003906928922590 raffaella.mancini@abbvie.com
Contact: Amanda Stubblefield 847-938-0277 amanda.stubblefield@abbvie.com

Locations
Italy
Site Reference ID/Investigator# 83929 Recruiting
Acquaviva delle Fonti, Italy, 70021
Principal Investigator: Site Reference ID/Investigator# 83929         
Site Reference ID/Investigator# 83715 Recruiting
Biella, Italy, 13900
Principal Investigator: Site Reference ID/Investigator# 83715         
Site Reference ID/Investigator# 83717 Recruiting
Catania, Italy, 95121
Principal Investigator: Site Reference ID/Investigator# 83717         
Site Reference ID/Investigator# 83721 Recruiting
Ferrara, Italy, 44100
Principal Investigator: Site Reference ID/Investigator# 83721         
Site Reference ID/Investigator# 83720 Not yet recruiting
Mestre, Italy
Principal Investigator: Site Reference ID/Investigator# 83720         
Site Reference ID/Investigator# 83713 Recruiting
Milan, Italy, 20139
Principal Investigator: Site Reference ID/Investigator# 83713         
Site Reference ID/Investigator# 83924 Recruiting
Monserrato, Cagliari, Italy, 09042
Principal Investigator: Site Reference ID/Investigator# 83924         
Site Reference ID/Investigator# 83719 Recruiting
Pavia, Italy, 27100
Principal Investigator: Site Reference ID/Investigator# 83719         
Site Reference ID/Investigator# 83718 Recruiting
Pozzilli, Italy, 86077
Principal Investigator: Site Reference ID/Investigator# 83718         
Site Reference ID/Investigator# 83927 Recruiting
Rome, Italy, 00165
Principal Investigator: Site Reference ID/Investigator# 83927         
Site Reference ID/Investigator# 83926 Recruiting
Rome, Italy, 00165
Principal Investigator: Site Reference ID/Investigator# 83926         
Site Reference ID/Investigator# 83714 Not yet recruiting
Salerno, Italy, 84131
Principal Investigator: Site Reference ID/Investigator# 83714         
Site Reference ID/Investigator# 83716 Not yet recruiting
Torino, Italy, 10126
Principal Investigator: Site Reference ID/Investigator# 83716         
Site Reference ID/Investigator# 83928 Not yet recruiting
Torino, Italy, 10126
Principal Investigator: Site Reference ID/Investigator# 83928         
Site Reference ID/Investigator# 83925 Recruiting
Udine, Italy, 33100
Principal Investigator: Site Reference ID/Investigator# 83925         
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Koray Onuk AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01754129     History of Changes
Other Study ID Numbers: P13-895
Study First Received: December 18, 2012
Last Updated: January 5, 2014
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by AbbVie:
Parkinson's Disease
Quality of Life
Caregiver

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Carbidopa
Levodopa
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014