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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02906488

Enrollment

839

Registered

2016-09-20

Start date

2016-09-12

Completion date

2025-07-24

Last updated

2025-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Quality of life

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Time-dependent Change in Off Time and On Time Accompanied By Dyskinesia Interfering with Daily Activities	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.
Time-dependent Change in Unified Parkinson's Disease Rating Scale (UPDRS)	104 Weeks	Motor evaluation
Time-dependent Change in Parkinson's Disease Questionnaire - 8 Items (PDQ-8)	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).
Off Period and On Period Accompanied by Dyskenesia Interfering with Daily Activities by Patient Characteristic Factor	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.
Time-dependent Change in Parkinson's Disease Quality of Life Questionnaire - Carers (PDQ-Carer)	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.

Countries

Japan

Outcome results