Special Drug Use-results Survey of Duodopa Enteral Solution in Patients With Parkinson's Disease
- Conditions
- Parkinson's Disease
- Registration Number
- NCT02906488
- Lead Sponsor
- AbbVie
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- Not specified
- 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.
NA
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 Unified Parkinson's Disease Rating Scale (UPDRS) 104 Weeks Motor evaluation
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 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.
Trial Locations
- Locations (115)
Nagoya City University Hospital /ID# 166893
🇯🇵Nagoya shi, Aichi, Japan
Nagoya University Hospital /ID# 212303
🇯🇵Nagoya-shi, Aichi, Japan
Toyota Memorial Hospital /ID# 166891
🇯🇵Toyota-shi, Aichi, Japan
Akita City Hospital /ID# 207121
🇯🇵Akita-shi, Akita, Japan
National Hospital Organization Akita National Hospital /ID# 207374
🇯🇵Yurihonjo-shi, Akita, Japan
Aomori Prefectural Central Hospital /ID# 165286
🇯🇵Aomori-shi, Aomori, Japan
Kameda General Hospital /ID# 166906
🇯🇵Kamogawa-shi, Chiba, Japan
Juntendo University Urayasu Hospital /ID# 162890
🇯🇵Urayasu-shi, Chiba, Japan
Saiseikai Matsuyama Hospital /ID# 169561
🇯🇵Matsuyama-shi, Ehime, Japan
Saiseikai Saijo Hospital /ID# 167705
🇯🇵Saijo-shi, Ehime, Japan
Scroll for more (105 remaining)Nagoya City University Hospital /ID# 166893🇯🇵Nagoya shi, Aichi, Japan