Global REsponsE During iNFusIon of a gEl With LevoDopa/Carbidopa

NCT01754129 | Completed Results

• 1 other identifier: P13-895
• Study Type: observational
• Target: 148
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson's Disease

Keywords

Caregiver; Quality of Life; Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• 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

  Section B of the UPDRS IV questionnaire consists of 4 individual items that assess the degree of clinical fluctuations. Item 39 is the percentage of "off" times (when PD symptoms are not adequately controlled by the drug) during the waking day. The Item 39 score ranges from 0 (None), 1 (1- 25% of the waking day), 2 (26 - 50% of the waking day), 3 (51 - 75% of the waking day), and 4 (76 - 100% of the waking day). The mean change from baseline was calculated as the score at the last available follow up visit minus the score at baseline/Visit 1. Negative change from baseline for "off" time indicates improvement.

  Baseline/Visit 1 and Visit 2 (Year 1) or Visit 3 (Year 2)

Secondary Outcomes (12)

• Unified Parkinson's Disease Rating Scale (UPDRS) IV (Complications of Therapy) Part A+B Score: Mean Change From Baseline to Visits 2 and 3

  Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)

• 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

  Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)

• Change in Parkinson's Disease Quality of Life Questionnaire (PDQ-39) Scores

  Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)

• Change in Parkinson's Disease Sleep Scale Version 2 (PDSS-2) Scores

  Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)

• Change in Gait and Falls Questionnaire (GFQ) Scores

  Baseline/Visit 1, Visit 2 (Year 1), and Visit 3 (Year 2)

Study Arms (1)

Participants with Parkinson's disease

Participants with advanced levodopa-responsive Parkinson's disease and severe motor fluctuations and hyper-/dyskinesia who were prescribed and treated in accordance with the local levodopa/carbidopa intestinal gel product label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

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

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• AbbVie Inc

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: December 21, 2012
• Study Start: December 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 10, 2018
• Results First Posted: August 10, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share