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Completed

NCT Number: NCT02906488

Special Drug Use-results Survey of Duodopa Enteral Solution in Patients With Parkinson's Disease

The purpose of this study is to assess the safety and efficacy of long-term use of Duodopa in patients with Parkinkon's disease in actual usage

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nagoya City University Hospital /ID# 166893, Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with Parkinson's disease using Duodopa for the purpose of improving circadian change (wearing-off phenomenon) of symptoms of Parkinson's disease in which sufficient effect cannot be obtained with existing drug therapy including levodopa-containing drugs.

Exclusion criteria

NA

Treatment and study plan

Primary outcomes

  1. Change in "Off" Periods From Start of Treatment to Week 104

    Time frame: 104 weeks

    "Off" periods describe those times when medication is not working well and a person has greater difficulty with movement.

Secondary outcomes

  1. Time-dependent Change in "Off" Time and "On" Time Accompanied By Dyskinesia Interfering with Daily Activities

    Time frame: 104 Weeks

    "Off" periods describe those times when medication is not working well and a person has greater difficulty with movement, and "On" periods describe when medication is working well and symptoms are controlled.

  2. Time-dependent Change in Unified Parkinson's Disease Rating Scale (UPDRS)

    Time frame: 104 Weeks

    Motor evaluation

  3. Time-dependent Change in Parkinson's Disease Questionnaire - 8 Items (PDQ-8)

    Time frame: 104 weeks

    The PDQ-8 is a quality of life questionnaire for PD patient. This short-form version derived from the PDQ-39 includes 1 question from each of the domains on the PDQ-39 (mobility, ADLs, emotional well-being, stigma, social support, cognitions, communication, and bodily discomfort).

  4. "Off" Period and "On" Period Accompanied by Dyskenesia Interfering with Daily Activities by Patient Characteristic Factor

    Time frame: 104 weeks

    "Off" periods describe those times when medication is not working well and a person has greater difficulty with movement, and "On" periods describe when medication is working well and symptoms are controlled.

  5. Time-dependent Change in Parkinson's Disease Quality of Life Questionnaire - Carers (PDQ-Carer)

    Time frame: 104 weeks

    The PDQ-Carer is a 29 item measure of health related quality of life for use with carers of people with Parkinson's disease.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Special Drug Use Results Survey of Safety and Efficacy of Long-term (104 Weeks) Use of Duodopa Enteral Solution in Patients With Parkinson's Disease in Actual Usage Condition

Important dates

Study start
2016
Primary completion
2025
Study completion
2025
First posted
Sep 20, 2016
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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