NCT01754129

Global REsponsE During iNFusIon of a gEl With LevoDopa/Carbidopa

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 148 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2012-12-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2012-12-21
• Last updated: 2018-08-10
• Results posted: 2018-08-10