Clinical trial NCT02906488: Special Drug Use-results Survey of Duodopa Enteral Solution in Patients With Parkinson's Disease
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Parkinson's Disease
Keywords: Quality of life
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-09-20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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


Eligibility criteria: 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

Primary outcomes:
measure: Change in "Off" Periods From Start of Treatment to Week 104
timeFrame: 104 weeks
Secondary outcomes:
measure: Time-dependent Change in "Off" Time and "On" Time Accompanied By Dyskinesia Interfering with Daily Activities
timeFrame: 104 Weeks
measure: Time-dependent Change in Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: 104 Weeks
measure: Time-dependent Change in Parkinson's Disease Questionnaire - 8 Items (PDQ-8)
timeFrame: 104 weeks
measure: "Off" Period and "On" Period Accompanied by Dyskenesia Interfering with Daily Activities by Patient Characteristic Factor
timeFrame: 104 weeks
measure: Time-dependent Change in Parkinson's Disease Quality of Life Questionnaire - Carers (PDQ-Carer)
timeFrame: 104 weeks
Other outcomes:
Locations:
city: Nagoya shi
country: Japan
facility: Nagoya City University Hospital /ID# 166893
state: Aichi
city: Nagoya-shi
country: Japan
facility: Nagoya University Hospital /ID# 212303
state: Aichi
city: Toyota-shi
country: Japan
facility: Toyota Memorial Hospital /ID# 166891
state: Aichi
city: Akita-shi
country: Japan
facility: Akita City Hospital /ID# 207121
state: Akita
city: Yurihonjo-shi
country: Japan
facility: National Hospital Organization Akita National Hospital /ID# 207374
state: Akita
city: Aomori-shi
country: Japan
facility: Aomori Prefectural Central Hospital /ID# 165286
state: Aomori
city: Kamogawa-shi
country: Japan
facility: Kameda General Hospital /ID# 166906
state: Chiba
city: Urayasu-shi
country: Japan
facility: Juntendo University Urayasu Hospital /ID# 162890
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Saiseikai Matsuyama Hospital /ID# 169561
state: Ehime
city: Saijo-shi
country: Japan
facility: Saiseikai Saijo Hospital /ID# 167705
state: Ehime
city: Toon-shi
country: Japan
facility: Ehime University Hospital /ID# 162889
state: Ehime
city: Fukui-shi
country: Japan
facility: Fukui Red Cross Hospital /ID# 166907
state: Fukui
city: Fukuoka-shi
country: Japan
facility: Fukuoka University Hospital /ID# 166900
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Kitakyushu Yahata Higashi Hospital /ID# 213849
state: Fukuoka
city: Kitakyusyu-shi
country: Japan
facility: Wakamatsu Hospital /ID# 160818
state: Fukuoka
city: Fukushima-shi
country: Japan
facility: Fukushima Medical University Hospital /ID# 169560
state: Fukushima
city: Gifu-shi
country: Japan
facility: Gifu Municipal Hospital /ID# 207777
state: Gifu
city: Gifu-shi
country: Japan
facility: Gifu University Hospital /ID# 207378
state: Gifu
city: Isesaki-shi
country: Japan
facility: Mihara Memorial /ID# 252885
state: Gunma
city: Ota-shi
country: Japan
facility: SUBARU Health Insurance Society Ota Memorial Hospital /ID# 207778
state: Gunma
city: Takasaki-shi
country: Japan
facility: National Hospital Organization Takasaki General Medical Center /ID# 207773
state: Gunma
city: Hiroshima-shi
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital /ID# 207126
state: Hiroshima
city: Asahikawa-shi
country: Japan
facility: Japanese Red Cross Asahikawa Hospital /ID# 207149
state: Hokkaido
city: Asahikawa-shi
country: Japan
facility: National Hospital Organization Asahikawa Medical Center /ID# 155744
state: Hokkaido
city: Date-shi
country: Japan
facility: Date Red Cross Hospital /ID# 207776
state: Hokkaido
city: Hakodate-shi
country: Japan
facility: Hakodate Municipal Hospital /ID# 212304
state: Hokkaido
city: Muroran-shi
country: Japan
facility: Muroran-Clinic /ID# 207780
state: Hokkaido
city: Obihiro-shi
country: Japan
facility: Obihiro kosei Hospital /ID# 166904
state: Hokkaido
city: Obihiro-shi
country: Japan
facility: Hokuto Hospital /ID# 207850
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Sapporo Medical University Hospital /ID# 207373
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Sapporo City General Hospital /ID# 212305
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital /ID# 166902
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Sapporo Neurology Hospital /ID# 207779
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Kobe Home Clinic of Neurology /ID# 212308
state: Hyogo
city: Kobe-shi
country: Japan
facility: Kobe University Hospital /ID# 166895
state: Hyogo
city: Kobe-shi
country: Japan
facility: Nishi-Kobe Medical Center /ID# 207781
state: Hyogo
city: Nishinomiya-shi
country: Japan
facility: Hyogo Medical University Hospital /ID# 169562
state: Hyogo
city: Sanda-shi
country: Japan
facility: Hyogo-Chuo National Hospital /ID# 207376
state: Hyogo
city: Tanbasasayama-shi
country: Japan
facility: Hyogo College of Medicine Sasayama Medical Center /ID# 208716
state: Hyogo
city: Ryugasaki-shi
country: Japan
facility: Ryugasaki Saiseikai Hospital /ID# 207846
state: Ibaraki
city: Toride-shi
country: Japan
facility: JA Toride Medical Center /ID# 212302
state: Ibaraki
city: Aira-shi
country: Japan
facility: Minami Kyushu National Hospital /ID# 171052
state: Kagoshima
city: Kagoshima-shi
country: Japan
facility: Okatsu Hospital /ID# 213489
state: Kagoshima
city: Kagoshima-shi
country: Japan
facility: Kagoshima University Hospital /ID# 166909
state: Kagoshima
city: Minamikyusyu-shi
country: Japan
facility: Kikuno Hospital /ID# 207784
state: Kagoshima
city: Isehara-shi
country: Japan
facility: Tokai University Hospital /ID# 250954
state: Kanagawa
city: Kawasaki-shi
country: Japan
facility: St. Marianna University Hospital /ID# 207119
state: Kanagawa
city: Sagamihara-shi
country: Japan
facility: National Hospital Organization Sagamihara National Hospital /ID# 160825
state: Kanagawa
city: Yokohama shi
country: Japan
facility: Yokohama City University Medical Center /ID# 165285
state: Kanagawa
city: Nankoku-shi
country: Japan
facility: Kochi Medical School Hospital /ID# 166903
state: Kochi
city: Kyoto-shi
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine /ID# 207130
state: Kyoto
city: Kyoto-shi
country: Japan
facility: Kyoto University Hospital /ID# 162891
state: Kyoto
city: Kyoto-shi
country: Japan
facility: National Hospital Organization Utano National Hospital /ID# 164139
state: Kyoto
city: Tsu-shi
country: Japan
facility: Mie University Hospital /ID# 164140
state: Mie
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital /ID# 169557
state: Miyagi
city: Sendai-shi
country: Japan
facility: NHO Sendai Nishitaga National Hospital /ID# 164977
state: Miyagi
city: Sendai-shi
country: Japan
facility: Tohoku Medical and Pharmaceuti /ID# 169558
state: Miyagi
city: Sendai-shi
country: Japan
facility: National Hospital Organization Sendai Medical Center /ID# 160831
state: Miyagi
city: Kobayashi-shi
country: Japan
facility: Kobayashi City Hospital /ID# 208715
state: Miyazaki
city: Miyakonojo-shi
country: Japan
facility: Fujimoto General Hospital /ID# 207150
state: Miyazaki
city: Matsumoto-shi
country: Japan
facility: Aizawa Hospital /ID# 212307
state: Nagano
city: Matsumoto-shi
country: Japan
facility: Shinshu University Hospital /ID# 169559
state: Nagano
city: Nishisonogi-gun
country: Japan
facility: Nagasaki Kita Hospital /ID# 204353
state: Nagasaki
city: Kashihara-shi
country: Japan
facility: Nara Medical University Hospital /ID# 160830
state: Nara
city: Yoshino-gun
country: Japan
facility: Minami-nara General Medical Center /ID# 207372
state: Nara
city: Kashiwazaki-shi
country: Japan
facility: NHO Niigata National Hospital /ID# 204337
state: Niigata
city: Nagaoka-shi
country: Japan
facility: Nagaoka Red Cross Hospital /ID# 212301
state: Niigata
city: Niigata-shi
country: Japan
facility: Midori Hospital /ID# 207127
state: Niigata
city: Oita-shi
country: Japan
facility: Oita Prefectural Hospital /ID# 208714
state: Oita
city: Okayama-shi
country: Japan
facility: Okayama Kyokuto Hospital /ID# 166892
state: Okayama
city: Shimajiri-gun
country: Japan
facility: Nanbu Medical Center / Nanbu Child Medical Center /ID# 207148
state: Okinawa
city: Izumi-shi
country: Japan
facility: Izumi City General Hospital /ID# 207775
state: Osaka
city: Kadoma-shi
country: Japan
facility: Kayashimaikuno Hospital /ID# 171051
state: Osaka
city: Mino-shi
country: Japan
facility: Mino City Hospital /ID# 161765
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka Saiseikai Nakatsu Hospital /ID# 168357
state: Osaka
city: Osaka-shi
country: Japan
facility: Japanese Red Cross Osaka Hospital /ID# 207123
state: Osaka
city: Sakai-shi
country: Japan
facility: Sakai Hospital Kinki Univ /ID# 166908
state: Osaka
city: Suita-shi
country: Japan
facility: Osaka University Hospital /ID# 161764
state: Osaka
city: Ageo-shi
country: Japan
facility: Saitama Rihabilitation Center /ID# 168356
state: Saitama
city: Saitama-shi
country: Japan
facility: Jichi Medical University Saitama Medical Center /ID# 207181
state: Saitama
city: Otsu-shi
country: Japan
facility: Shiga University of Medical Science Hospital /ID# 212306
state: Shiga
city: Matsue-shi
country: Japan
facility: NHO Matsue Medical Center /ID# 164135
state: Shimane
city: Fujieda-shi
country: Japan
facility: Nanpuh Hospital /ID# 207128
state: Shizuoka
city: Izunokuni-shi
country: Japan
facility: Juntendo University Shizuoka Hospital /ID# 207133
state: Shizuoka
city: Ashikaga-shi
country: Japan
facility: Japanese Red Cross Ashikaga Hospital /ID# 210476
state: Tochigi
city: Mooka-shi
country: Japan
facility: Moka Chuo Clinic /ID# 213490
state: Tochigi
city: Shimotsuga-gun
country: Japan
facility: Dokkyo Medical University Hospital /ID# 171050
state: Tochigi
city: Tokushima-shi
country: Japan
facility: Itsuki Hospital /ID# 164138
state: Tokushima
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital /ID# 160823
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Nippon Medical School Hospital /ID# 207118
state: Tokyo
city: Kodaira-shi
country: Japan
facility: National Center of Neurology and Psychiatry /ID# 160824
state: Tokyo
city: Minato-ku
country: Japan
facility: Mita Hospital /ID# 207210
state: Tokyo
city: Nakano-ku
country: Japan
facility: Nitobe Memorial Nakano General Hospital /ID# 207377
state: Tokyo
city: Ota-ku
country: Japan
facility: Toho University Medical Center Omori Hospital /ID# 212271
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Japanese Red Cross Medical Center /ID# 207129
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital /ID# 212267
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital /ID# 204350
state: Tokyo
city: Yonago-shi
country: Japan
facility: Nomura Neuro Sleep Clinic /ID# 213491
state: Tottori
city: Yonago-shi
country: Japan
facility: Tottori University Hospital /ID# 207124
state: Tottori
city: Shingu-shi
country: Japan
facility: Shingu Municipal Medical Center /ID# 207131
state: Wakayama
city: Wakayama-shi
country: Japan
facility: Wakayama Medical University Hospital /ID# 160817
state: Wakayama
city: Shimonoseki-shi
country: Japan
facility: National Hospital Organization Kanmon Medical Center /ID# 207370
state: Yamaguchi
city: Shunan-shi
country: Japan
facility: Tokuyama Central Hospital /ID# 171049
state: Yamaguchi
city: Ube-shi
country: Japan
facility: Yamaguchi University Hospital /ID# 207774
state: Yamaguchi
city: Yanai-shi
country: Japan
facility: NHO Yanai Medical Center /ID# 164137
state: Yamaguchi
city: Chuo-shi
country: Japan
facility: University of Yamanashi Hospital /ID# 207120
state: Yamanashi
city: Gifu-shi
country: Japan
facility: Gifu Prefectural General Medical Center /ID# 166894
city: Higashiosaka-shi
country: Japan
facility: Higashiosaka City Medical Center /ID# 166901
city: Himeji-shi
country: Japan
facility: Himeji Central Hospital /ID# 164136
city: Hiroshima-shi
country: Japan
facility: Hiroshima Teishin Hospital /ID# 245072
city: Ina-shi
country: Japan
facility: Ina Central Hospital /ID# 166905
city: Miyazaki
country: Japan
facility: Junwakai Memorial Hospital /ID# 164141
city: Sakata-shi
country: Japan
facility: Nihonkai General Hospital /ID# 207196
city: Sapporo-shi
country: Japan
facility: Hokkaido Medical Center /ID# 161763
city: Tachikawa
country: Japan
facility: Tachikawa Hospital /ID# 207182
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: