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NCT02906488 Clinical Trial

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

Parkinson's Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02906488
Other study ID # P15-720
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 12, 2016
Est. completion date August 29, 2025

Study information
Verified date June 2024
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 0
Est. completion date August 29, 2025
Est. primary completion date August 29, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Saitama Rihabilitation Center /ID# 168356 Ageo-shi Saitama
Japan Minami Kyushu National Hospital /ID# 171052 Aira-shi Kagoshima
Japan Akita City Hospital /ID# 207121 Akita-shi Akita
Japan Aomori Prefectural Central Hospital /ID# 165286 Aomori-shi Aomori
Japan Japanese Red Cross Asahikawa Hospital /ID# 207149 Asahikawa-shi Hokkaido
Japan National Hospital Organization Asahikawa Medical Center /ID# 155744 Asahikawa-shi Hokkaido
Japan Japanese Red Cross Ashikaga Hospital /ID# 210476 Ashikaga-shi Tochigi
Japan Juntendo University Hospital /ID# 160823 Bunkyo-ku Tokyo
Japan Nippon Medical School Hospital /ID# 207118 Bunkyo-ku Tokyo
Japan University of Yamanashi Hospital /ID# 207120 Chuo-shi Yamanashi
Japan Date Red Cross Hospital /ID# 207776 Date-shi Hokkaido
Japan Nanpuh Hospital /ID# 207128 Fujieda-shi Shizuoka
Japan Fukui Red Cross Hospital /ID# 166907 Fukui-shi Fukui
Japan Fukuoka University Hospital /ID# 166900 Fukuoka-shi Fukuoka
Japan Fukushima Medical University Hospital /ID# 169560 Fukushima-shi Fukushima
Japan Gifu Municipal Hospital /ID# 207777 Gifu-shi Gifu
Japan Gifu Prefectural General Medical Center /ID# 166894 Gifu-shi
Japan Gifu University Hospital /ID# 207378 Gifu-shi Gifu
Japan Hakodate Municipal Hospital /ID# 212304 Hakodate-shi Hokkaido
Japan Higashiosaka City Medical Center /ID# 166901 Higashiosaka-shi
Japan Himeji Central Hospital /ID# 164136 Himeji-shi
Japan Hiroshima City Hiroshima Citizens Hospital /ID# 207126 Hiroshima-shi Hiroshima
Japan Hiroshima Teishin Hospital /ID# 245072 Hiroshima-shi
Japan Ina Central Hospital /ID# 166905 Ina-shi
Japan Tokai University Hospital /ID# 250954 Isehara-shi Kanagawa
Japan Mihara Memorial /ID# 252885 Isesaki-shi Gunma
Japan Izumi City General Hospital /ID# 207775 Izumi-shi Osaka
Japan Juntendo University Shizuoka Hospital /ID# 207133 Izunokuni-shi Shizuoka
Japan Kayashimaikuno Hospital /ID# 171051 Kadoma-shi Osaka
Japan Kagoshima University Hospital /ID# 166909 Kagoshima-shi Kagoshima
Japan Okatsu Hospital /ID# 213489 Kagoshima-shi Kagoshima
Japan Kameda General Hospital /ID# 166906 Kamogawa-shi Chiba
Japan Nara Medical University Hospital /ID# 160830 Kashihara-shi Nara
Japan NHO Niigata National Hospital /ID# 204337 Kashiwazaki-shi Niigata
Japan St. Marianna University Hospital /ID# 207119 Kawasaki-shi Kanagawa
Japan Kitakyushu Yahata Higashi Hospital /ID# 213849 Kitakyushu-shi Fukuoka
Japan Wakamatsu Hospital /ID# 160818 Kitakyusyu-shi Fukuoka
Japan Kobayashi City Hospital /ID# 208715 Kobayashi-shi Miyazaki
Japan Kobe Home Clinic of Neurology /ID# 212308 Kobe-shi Hyogo
Japan Kobe University Hospital /ID# 166895 Kobe-shi Hyogo
Japan Nishi-Kobe Medical Center /ID# 207781 Kobe-shi Hyogo
Japan National Center of Neurology and Psychiatry /ID# 160824 Kodaira-shi Tokyo
Japan Kyoto University Hospital /ID# 162891 Kyoto-shi Kyoto
Japan National Hospital Organization Utano National Hospital /ID# 164139 Kyoto-shi Kyoto
Japan University Hospital Kyoto Prefectural University of Medicine /ID# 207130 Kyoto-shi Kyoto
Japan NHO Matsue Medical Center /ID# 164135 Matsue-shi Shimane
Japan Aizawa Hospital /ID# 212307 Matsumoto-shi Nagano
Japan Shinshu University Hospital /ID# 169559 Matsumoto-shi Nagano
Japan Saiseikai Matsuyama Hospital /ID# 169561 Matsuyama-shi Ehime
Japan Kikuno Hospital /ID# 207784 Minamikyusyu-shi Kagoshima
Japan Mita Hospital /ID# 207210 Minato-ku Tokyo
Japan Mino City Hospital /ID# 161765 Mino-shi Osaka
Japan Fujimoto General Hospital /ID# 207150 Miyakonojo-shi Miyazaki
Japan Junwakai Memorial Hospital /ID# 164141 Miyazaki
Japan Moka Chuo Clinic /ID# 213490 Mooka-shi Tochigi
Japan Muroran-Clinic /ID# 207780 Muroran-shi Hokkaido
Japan Nagaoka Red Cross Hospital /ID# 212301 Nagaoka-shi Niigata
Japan Nagoya City University Hospital /ID# 166893 Nagoya shi Aichi
Japan Nagoya University Hospital /ID# 212303 Nagoya-shi Aichi
Japan Nitobe Memorial Nakano General Hospital /ID# 207377 Nakano-ku Tokyo
Japan Kochi Medical School Hospital /ID# 166903 Nankoku-shi Kochi
Japan Midori Hospital /ID# 207127 Niigata-shi Niigata
Japan Hyogo Medical University Hospital /ID# 169562 Nishinomiya-shi Hyogo
Japan Nagasaki Kita Hospital /ID# 204353 Nishisonogi-gun Nagasaki
Japan Hokuto Hospital /ID# 207850 Obihiro-shi Hokkaido
Japan Obihiro kosei Hospital /ID# 166904 Obihiro-shi Hokkaido
Japan Oita Prefectural Hospital /ID# 208714 Oita-shi Oita
Japan Okayama Kyokuto Hospital /ID# 166892 Okayama-shi Okayama
Japan Japanese Red Cross Osaka Hospital /ID# 207123 Osaka-shi Osaka
Japan Osaka Saiseikai Nakatsu Hospital /ID# 168357 Osaka-shi Osaka
Japan Toho University Medical Center Omori Hospital /ID# 212271 Ota-ku Tokyo
Japan SUBARU Health Insurance Society Ota Memorial Hospital /ID# 207778 Ota-shi Gunma
Japan Shiga University of Medical Science Hospital /ID# 212306 Otsu-shi Shiga
Japan Ryugasaki Saiseikai Hospital /ID# 207846 Ryugasaki-shi Ibaraki
Japan National Hospital Organization Sagamihara National Hospital /ID# 160825 Sagamihara-shi Kanagawa
Japan Saiseikai Saijo Hospital /ID# 167705 Saijo-shi Ehime
Japan Jichi Medical University Saitama Medical Center /ID# 207181 Saitama-shi Saitama
Japan Sakai Hospital Kinki Univ /ID# 166908 Sakai-shi Osaka
Japan Nihonkai General Hospital /ID# 207196 Sakata-shi
Japan Hyogo-Chuo National Hospital /ID# 207376 Sanda-shi Hyogo
Japan Hokkaido Medical Center /ID# 161763 Sapporo-shi
Japan Hokkaido University Hospital /ID# 166902 Sapporo-shi Hokkaido
Japan Sapporo City General Hospital /ID# 212305 Sapporo-shi Hokkaido
Japan Sapporo Medical University Hospital /ID# 207373 Sapporo-shi Hokkaido
Japan Sapporo Neurology Hospital /ID# 207779 Sapporo-shi Hokkaido
Japan National Hospital Organization Sendai Medical Center /ID# 160831 Sendai-shi Miyagi
Japan NHO Sendai Nishitaga National Hospital /ID# 164977 Sendai-shi Miyagi
Japan Tohoku Medical and Pharmaceuti /ID# 169558 Sendai-shi Miyagi
Japan Tohoku University Hospital /ID# 169557 Sendai-shi Miyagi
Japan Japanese Red Cross Medical Center /ID# 207129 Shibuya-ku Tokyo
Japan Nanbu Medical Center / Nanbu Child Medical Center /ID# 207148 Shimajiri-gun Okinawa
Japan National Hospital Organization Kanmon Medical Center /ID# 207370 Shimonoseki-shi Yamaguchi
Japan Dokkyo Medical University Hospital /ID# 171050 Shimotsuga-gun Tochigi
Japan Shingu Municipal Medical Center /ID# 207131 Shingu-shi Wakayama
Japan Keio University Hospital /ID# 212267 Shinjuku-ku Tokyo
Japan Tokyo Women's Medical University Hospital /ID# 204350 Shinjuku-ku Tokyo
Japan Tokuyama Central Hospital /ID# 171049 Shunan-shi Yamaguchi
Japan Osaka University Hospital /ID# 161764 Suita-shi Osaka
Japan Tachikawa Hospital /ID# 207182 Tachikawa
Japan National Hospital Organization Takasaki General Medical Center /ID# 207773 Takasaki-shi Gunma
Japan Hyogo College of Medicine Sasayama Medical Center /ID# 208716 Tanbasasayama-shi Hyogo
Japan Itsuki Hospital /ID# 164138 Tokushima-shi Tokushima
Japan Ehime University Hospital /ID# 162889 Toon-shi Ehime
Japan JA Toride Medical Center /ID# 212302 Toride-shi Ibaraki
Japan Toyota Memorial Hospital /ID# 166891 Toyota-shi Aichi
Japan Mie University Hospital /ID# 164140 Tsu-shi Mie
Japan Yamaguchi University Hospital /ID# 207774 Ube-shi Yamaguchi
Japan Juntendo University Urayasu Hospital /ID# 162890 Urayasu-shi Chiba
Japan Wakayama Medical University Hospital /ID# 160817 Wakayama-shi Wakayama
Japan NHO Yanai Medical Center /ID# 164137 Yanai-shi Yamaguchi
Japan Yokohama City University Medical Center /ID# 165285 Yokohama shi Kanagawa
Japan Nomura Neuro Sleep Clinic /ID# 213491 Yonago-shi Tottori
Japan Tottori University Hospital /ID# 207124 Yonago-shi Tottori
Japan Minami-nara General Medical Center /ID# 207372 Yoshino-gun Nara
Japan National Hospital Organization Akita National Hospital /ID# 207374 Yurihonjo-shi Akita

Sponsors (1)
Lead Sponsor Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Time-dependent Change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor evaluation 104 Weeks
Secondary 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
Secondary "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
Secondary 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
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