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Global REsponsE During iNFusIon of a gEl With LevoDopa/Carbidopa

NCT01754129 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 148

Last updated 2018-08-10

Study results available
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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

Sponsors & Collaborators

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • AbbVie Inc · AbbVie

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2016-05-31
Completion
2016-05-31

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Entities

Diseases

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 NCT01754129 on ClinicalTrials.gov