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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Parkinson's Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Parkinson's Disease<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Off Periods From Start of Treatment to Week 104 | Off periods describe those times when medication is not working well and a person has greater difficulty with movement. | 104 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-dependent Change in Off Time and On Time Accompanied By Dyskinesia Interfering with Daily Activities | 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. | 104 Weeks | 
| Time-dependent Change in Unified Parkinson's Disease Rating Scale (UPDRS) | Motor evaluation | 104 Weeks | 
| Time-dependent Change in Parkinson's Disease Questionnaire - 8 Items (PDQ-8) | 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). | 104 weeks | 
| Off Period and On Period Accompanied by Dyskenesia Interfering with Daily Activities by Patient Characteristic Factor | 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. | 104 weeks | 
| Time-dependent Change in Parkinson's Disease Quality of Life Questionnaire - Carers (PDQ-Carer) | The PDQ-Carer is a 29 item measure of health related quality of life for use with carers of people with Parkinson's disease. | 104 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life