MedPath

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

Active, not recruiting
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
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

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in "Off" Periods From Start of Treatment to Week 104104 weeks

"Off" periods describe those times when medication is not working well and a person has greater difficulty with movement.

Secondary Outcome Measures
NameTimeMethod
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 Factor104 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 Activities104 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)

Fukui Red Cross Hospital /ID# 166907

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Fukui-shi, Fukui, Japan

National Hospital Organization Takasaki General Medical Center /ID# 207773

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Takasaki-shi, Gunma, Japan

Muroran-Clinic /ID# 207780

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Muroran-shi, Hokkaido, Japan

Sapporo Neurology Hospital /ID# 207779

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Sapporo-shi, Hokkaido, Japan

Hyogo Medical University Hospital /ID# 169562

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Nishinomiya-shi, Hyogo, Japan

Okatsu Hospital /ID# 213489

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Kagoshima-shi, Kagoshima, Japan

National Hospital Organization Utano National Hospital /ID# 164139

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Kyoto-shi, Kyoto, Japan

Nagaoka Red Cross Hospital /ID# 212301

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Nagaoka-shi, Niigata, Japan

Midori Hospital /ID# 207127

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Niigata-shi, Niigata, Japan

Dokkyo Medical University Hospital /ID# 171050

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Shimotsuga-gun, Tochigi, Japan

Shingu Municipal Medical Center /ID# 207131

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Shingu-shi, Wakayama, Japan

Nomura Neuro Sleep Clinic /ID# 213491

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Yonago-shi, Tottori, Japan

Wakayama Medical University Hospital /ID# 160817

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Wakayama-shi, Wakayama, Japan

Yamaguchi University Hospital /ID# 207774

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Ube-shi, Yamaguchi, Japan

Mie University Hospital /ID# 164140

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Tsu-shi, Mie, Japan

Toyota Memorial Hospital /ID# 166891

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Toyota-shi, Aichi, Japan

Nagoya City University Hospital /ID# 166893

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Nagoya shi, Aichi, Japan

Nagoya University Hospital /ID# 212303

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Nagoya-shi, Aichi, Japan

Akita City Hospital /ID# 207121

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Akita-shi, Akita, Japan

Kameda General Hospital /ID# 166906

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Kamogawa-shi, Chiba, Japan

National Hospital Organization Akita National Hospital /ID# 207374

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Yurihonjo-shi, Akita, Japan

Aomori Prefectural Central Hospital /ID# 165286

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Aomori-shi, Aomori, Japan

Saiseikai Saijo Hospital /ID# 167705

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Saijo-shi, Ehime, Japan

Juntendo University Urayasu Hospital /ID# 162890

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Urayasu-shi, Chiba, Japan

Saiseikai Matsuyama Hospital /ID# 169561

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Matsuyama-shi, Ehime, Japan

Ehime University Hospital /ID# 162889

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Toon-shi, Ehime, Japan

Fukuoka University Hospital /ID# 166900

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Fukuoka-shi, Fukuoka, Japan

Kitakyushu Yahata Higashi Hospital /ID# 213849

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Kitakyushu-shi, Fukuoka, Japan

Wakamatsu Hospital /ID# 160818

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Kitakyusyu-shi, Fukuoka, Japan

Gifu Municipal Hospital /ID# 207777

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Gifu-shi, Gifu, Japan

Fukushima Medical University Hospital /ID# 169560

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Fukushima-shi, Fukushima, Japan

Gifu University Hospital /ID# 207378

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Gifu-shi, Gifu, Japan

Mihara Memorial /ID# 252885

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Isesaki-shi, Gunma, Japan

SUBARU Health Insurance Society Ota Memorial Hospital /ID# 207778

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Ota-shi, Gunma, Japan

Hiroshima City Hiroshima Citizens Hospital /ID# 207126

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Hiroshima-shi, Hiroshima, Japan

National Hospital Organization Asahikawa Medical Center /ID# 155744

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Asahikawa-shi, Hokkaido, Japan

Japanese Red Cross Asahikawa Hospital /ID# 207149

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Asahikawa-shi, Hokkaido, Japan

Hakodate Municipal Hospital /ID# 212304

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Hakodate-shi, Hokkaido, Japan

Date Red Cross Hospital /ID# 207776

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Date-shi, Hokkaido, Japan

Obihiro kosei Hospital /ID# 166904

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Obihiro-shi, Hokkaido, Japan

Hokuto Hospital /ID# 207850

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Obihiro-shi, Hokkaido, Japan

Sapporo Medical University Hospital /ID# 207373

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Sapporo-shi, Hokkaido, Japan

Sapporo City General Hospital /ID# 212305

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Sapporo-shi, Hokkaido, Japan

Kobe University Hospital /ID# 166895

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Kobe-shi, Hyogo, Japan

Kobe Home Clinic of Neurology /ID# 212308

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Kobe-shi, Hyogo, Japan

Nishi-Kobe Medical Center /ID# 207781

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Kobe-shi, Hyogo, Japan

Hokkaido University Hospital /ID# 166902

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Sapporo-shi, Hokkaido, Japan

Hyogo-Chuo National Hospital /ID# 207376

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Sanda-shi, Hyogo, Japan

Ryugasaki Saiseikai Hospital /ID# 207846

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Ryugasaki-shi, Ibaraki, Japan

Hyogo College of Medicine Sasayama Medical Center /ID# 208716

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Tanbasasayama-shi, Hyogo, Japan

Kagoshima University Hospital /ID# 166909

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Kagoshima-shi, Kagoshima, Japan

JA Toride Medical Center /ID# 212302

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Toride-shi, Ibaraki, Japan

Minami Kyushu National Hospital /ID# 171052

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Aira-shi, Kagoshima, Japan

St. Marianna University Hospital /ID# 207119

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Kawasaki-shi, Kanagawa, Japan

Kikuno Hospital /ID# 207784

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Minamikyusyu-shi, Kagoshima, Japan

Kyoto University Hospital /ID# 162891

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Kyoto-shi, Kyoto, Japan

Tokai University Hospital /ID# 250954

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Isehara-shi, Kanagawa, Japan

Tohoku University Hospital /ID# 169557

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Sendai-shi, Miyagi, Japan

National Hospital Organization Sagamihara National Hospital /ID# 160825

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Sagamihara-shi, Kanagawa, Japan

University Hospital Kyoto Prefectural University of Medicine /ID# 207130

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Kyoto-shi, Kyoto, Japan

Kochi Medical School Hospital /ID# 166903

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Nankoku-shi, Kochi, Japan

Yokohama City University Medical Center /ID# 165285

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Yokohama shi, Kanagawa, Japan

Tohoku Medical and Pharmaceuti /ID# 169558

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Sendai-shi, Miyagi, Japan

NHO Sendai Nishitaga National Hospital /ID# 164977

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Sendai-shi, Miyagi, Japan

National Hospital Organization Sendai Medical Center /ID# 160831

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Sendai-shi, Miyagi, Japan

Kobayashi City Hospital /ID# 208715

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Kobayashi-shi, Miyazaki, Japan

Shinshu University Hospital /ID# 169559

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Matsumoto-shi, Nagano, Japan

Fujimoto General Hospital /ID# 207150

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Miyakonojo-shi, Miyazaki, Japan

Aizawa Hospital /ID# 212307

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Matsumoto-shi, Nagano, Japan

Nagasaki Kita Hospital /ID# 204353

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Nishisonogi-gun, Nagasaki, Japan

Nara Medical University Hospital /ID# 160830

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Kashihara-shi, Nara, Japan

Okayama Kyokuto Hospital /ID# 166892

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Okayama-shi, Okayama, Japan

Minami-nara General Medical Center /ID# 207372

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Yoshino-gun, Nara, Japan

NHO Niigata National Hospital /ID# 204337

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Kashiwazaki-shi, Niigata, Japan

Oita Prefectural Hospital /ID# 208714

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Oita-shi, Oita, Japan

Osaka Saiseikai Nakatsu Hospital /ID# 168357

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Osaka-shi, Osaka, Japan

Nanbu Medical Center / Nanbu Child Medical Center /ID# 207148

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Shimajiri-gun, Okinawa, Japan

Izumi City General Hospital /ID# 207775

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Izumi-shi, Osaka, Japan

Mino City Hospital /ID# 161765

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Mino-shi, Osaka, Japan

Kayashimaikuno Hospital /ID# 171051

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Kadoma-shi, Osaka, Japan

Osaka University Hospital /ID# 161764

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Suita-shi, Osaka, Japan

Sakai Hospital Kinki Univ /ID# 166908

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Sakai-shi, Osaka, Japan

Japanese Red Cross Osaka Hospital /ID# 207123

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Osaka-shi, Osaka, Japan

Jichi Medical University Saitama Medical Center /ID# 207181

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Saitama-shi, Saitama, Japan

Shiga University of Medical Science Hospital /ID# 212306

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Otsu-shi, Shiga, Japan

Saitama Rihabilitation Center /ID# 168356

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Ageo-shi, Saitama, Japan

Nanpuh Hospital /ID# 207128

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Fujieda-shi, Shizuoka, Japan

Juntendo University Shizuoka Hospital /ID# 207133

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Izunokuni-shi, Shizuoka, Japan

Japanese Red Cross Ashikaga Hospital /ID# 210476

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Ashikaga-shi, Tochigi, Japan

NHO Matsue Medical Center /ID# 164135

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Matsue-shi, Shimane, Japan

Moka Chuo Clinic /ID# 213490

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Mooka-shi, Tochigi, Japan

Itsuki Hospital /ID# 164138

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Tokushima-shi, Tokushima, Japan

Toho University Medical Center Omori Hospital /ID# 212271

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Ota-ku, Tokyo, Japan

Keio University Hospital /ID# 212267

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Shinjuku-ku, Tokyo, Japan

Nippon Medical School Hospital /ID# 207118

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Bunkyo-ku, Tokyo, Japan

Tokuyama Central Hospital /ID# 171049

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Shunan-shi, Yamaguchi, Japan

NHO Yanai Medical Center /ID# 164137

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Yanai-shi, Yamaguchi, Japan

Tottori University Hospital /ID# 207124

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Yonago-shi, Tottori, Japan

Himeji Central Hospital /ID# 164136

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Himeji-shi, Japan

University of Yamanashi Hospital /ID# 207120

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Chuo-shi, Yamanashi, Japan

Gifu Prefectural General Medical Center /ID# 166894

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Gifu-shi, Japan

National Hospital Organization Kanmon Medical Center /ID# 207370

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Shimonoseki-shi, Yamaguchi, Japan

Higashiosaka City Medical Center /ID# 166901

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Higashiosaka-shi, Japan

Ina Central Hospital /ID# 166905

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Ina-shi, Japan

Junwakai Memorial Hospital /ID# 164141

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Miyazaki, Japan

Hiroshima Teishin Hospital /ID# 245072

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Hiroshima-shi, Japan

Nihonkai General Hospital /ID# 207196

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Sakata-shi, Japan

Hokkaido Medical Center /ID# 161763

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Sapporo-shi, Japan

Tachikawa Hospital /ID# 207182

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Tachikawa, Japan

Nitobe Memorial Nakano General Hospital /ID# 207377

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Nakano-ku, Tokyo, Japan

Juntendo University Hospital /ID# 160823

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Bunkyo-ku, Tokyo, Japan

Tokyo Women's Medical University Hospital /ID# 204350

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Shinjuku-ku, Tokyo, Japan

National Center of Neurology and Psychiatry /ID# 160824

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Kodaira-shi, Tokyo, Japan

Mita Hospital /ID# 207210

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Minato-ku, Tokyo, Japan

Japanese Red Cross Medical Center /ID# 207129

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Shibuya-ku, Tokyo, Japan

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