CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 77 enrolled
Drug / intervention
Levodopa-carbidopa intestinal gel (LCIG) +3 moredrug
Likely dose
Levodopa-carbidopa intestinal gel (LCIG) via percutaneous endoscopic gastrostomy with jejunal extension tube, delivered by CADD-Legacy 1400 infusion pumpAI-extracted
Key inclusion· 1
  • Advanced idiopathic Parkinson's disease
Key exclusion· 1
  • Other diseases which might influence compliance or participation in the study

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00141518
NCT00141518Phase 4Completed

A Long-term Health Economics Study of Intraduodenal Levodopa (Duodopa®) in Routine Care for Patients With Advanced Idiopathic Parkinson's Disease With Severe Motor Fluctuations and Hyper-/Dyskinesia

AbbVie (prior sponsor, Abbott)·interventional·Posted Sep 1, 2005·Updated Jul 18, 2016

In Brief

A Phase 4 clinical trial evaluating Levodopa-carbidopa intestinal gel (LCIG), CADD-Legacy® 1400 ambulatory infusion pump, and 2 other interventions for Advanced Idiopathic Parkinson's Disease. Completed, enrolled 77 participants.

Detailed Summary

The primary objective of this study is to collect health economic data depicting the initial levels and natural progression over time of resource usage, Parkinson's disease (PD)-related costs, and health related quality of life (HRQoL) for a cohort of advanced PD patients treated with Duodopa (levodopa-carbidopa in an intestinal gel formulation), of which about one-third were Duodopa-naïve prior to the start of the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 1, 2005
Enrollment StartMar 1, 2006
Primary CompletionMar 1, 2011
Study CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 20.8 years ago

Interventions

Levodopa-carbidopa intestinal gel (LCIG)drug

CADD-Legacy® 1400 ambulatory infusion pumpdevice

percutaneous endoscopic gastrostomy tube (PEG tube)device

jejunal extension tube (J-tube)device