Global REsponsE During iNFusIon of a gEl With LevoDopa/Carbidopa

NCT ID: NCT01754129

Last Updated: 2018-08-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 148 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2016-05-31

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).

Conditions

Parkinson's Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AbbVie Inc

Role: STUDY_DIRECTOR

AbbVie

Other Identifiers

P13-895

Identifier Type: -

Identifier Source: org_study_id