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Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic Impact

NCT00141518 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2016-07-18

Study results available
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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.

Conditions

  • Advanced Idiopathic Parkinson's Disease

Interventions

DRUG

Levodopa-carbidopa intestinal gel (LCIG)

DEVICE

CADD-Legacy® 1400 ambulatory infusion pump

DEVICE

percutaneous endoscopic gastrostomy tube (PEG tube)

DEVICE

jejunal extension tube (J-tube)

Sponsors & Collaborators

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Lars Bergmann, MD · AbbVie

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2011-03-31
Completion
2011-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00141518 on ClinicalTrials.gov