Clinical trial NCT01754129: Global REsponsE During iNFusIon of a gEl With LevoDopa/Carbidopa
Official title: Global REsponsE During iNFusIon of a gEl With LevoDopa/Carbidopa (GREENFIELD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Caregiver
Quality of Life
Parkinson's Disease
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-12-21
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants already on DUODOPA treatment in accordance with the 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 were offered the opportunity to enroll in this study.

Brief summary: This multicenter, post marketing observational study (PMOS) was designed to evaluate the long-term effectiveness of levodopa/carbidopa intestinal gel (DUODOPA) on motor fluctuations (duration of OFF periods) in participants with advanced levodopa-responsive Parkinson's disease (PD) and severe motor fluctuations and hyper-/dyskinesia (involuntary movements). Secondary objectives of this study were to assess the participants' quality of life; to assess the long-term safety of DUODOPA; to assess disability, cognitive function, and non-professional caregiver burden; and to assess the economic and social impact of family caregiver assistance.

Detailed description: Male or female participants ages 18 years of age who were already on DUODOPA treatment and had concluded the naso-intestinal phase were included in this study. DUODOPA was administered via a portable pump directly into the proximal small intestine via a percutaneous endoscopic transgastric jejunostomy (PEG-J) tube. There were 3 planned visits during the study: enrollment (Visit 1), 1 year (Visit 2), and 2 years (Visit 3).

Eligibility criteria: Inclusion Criteria:

* Participants already on treatment with DUODOPA (having already concluded the naso-intestinal treatment phase) according to the local DUODOPA product label and to routine clinical care for advanced PD patients
* Participants 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 participant's clinical chart
* Participant 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

Primary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Item 39 (Proportion of Waking Day Spent in "Off") Score: Mean Change From Baseline to the Last Available Follow up
timeFrame: Baseline/Visit 1 and Visit 2 (Year 1) or Visit 3 (Year 2)
Secondary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Part A+B Score: Mean Change From Baseline to Visits 2 and 3
timeFrame: Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)
measure: Change in Unified Parkinson's Disease Rating Scale on Mentation, Behavior and Mood (UPDRS I) and Activities of Daily Living (UPDRS II) During On and Off Phases
timeFrame: Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)
measure: Change in Parkinson's Disease Quality of Life Questionnaire (PDQ-39) Scores
timeFrame: Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)
measure: Change in Parkinson's Disease Sleep Scale Version 2 (PDSS-2) Scores
timeFrame: Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)
measure: Change in Gait and Falls Questionnaire (GFQ) Scores
timeFrame: Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)
measure: Change in Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) Scores
timeFrame: Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)
measure: Economic and Social Impact of Family-provided Healthcare
timeFrame: Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)
measure: Change in Relative Stress Scale (RSS) Scores
timeFrame: Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)
measure: Concomitant Diseases and Medications
timeFrame: Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)
measure: Change in Global Effectiveness on Motor Symptoms as Compared to Baseline
timeFrame: Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)
measure: Participant Self-assessment Scale of DUODOPA Therapy
timeFrame: Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)
measure: DUODOPA Total Daily Infusion Dosage
timeFrame: Baseline, Visit 1, Visit 2, (Year 1) and Visit 3 (Year 2)
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc
role: STUDY_DIRECTOR
References: