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

June 26, 2023 updated by: AbbVie

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

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

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Gifu-shi, Japan, 500-8727
        • Gifu Prefectural General Medical Center /ID# 166894
      • Higashiosaka-shi, Japan, 578-8588
        • Higashiosaka City Medical Center /ID# 166901
      • Himeji-shi, Japan, 672-8501
        • Himeji Central Hospital /ID# 164136
      • Hiroshima-shi, Japan, 730-8798
        • Hiroshima Teishin Hospital /ID# 245072
      • Ina-shi, Japan, 396-0033
        • Ina Central Hospital /ID# 166905
      • Miyazaki, Japan, 880-2112
        • Junwakai Memorial Hospital /ID# 164141
      • Sakata-shi, Japan, 998-0828
        • Nihonkai General Hospital /ID# 207196
      • Sapporo-shi, Japan, 063-0005
        • Hokkaido Medical Center /ID# 161763
      • Tachikawa, Japan
        • Tachikawa Hospital /ID# 207182
    • Aichi
      • Nagoya shi, Aichi, Japan, 467-8602
        • Nagoya City University Hospital /ID# 166893
      • Nagoya-shi, Aichi, Japan, 4668560
        • Nagoya University Hospital /ID# 212303
      • Toyota-shi, Aichi, Japan, 471-8513
        • Toyota Memorial Hospital /ID# 166891
    • Akita
      • Akita-shi, Akita, Japan, 010-0933
        • Akita City Hospital /ID# 207121
      • Yurihonjo-shi, Akita, Japan, 018-1301
        • National Hospital Organization Akita National Hospital /ID# 207374
    • Aomori
      • Aomori-shi, Aomori, Japan, 030-8553
        • Aomori Prefectural Central Hospital /ID# 165286
    • Chiba
      • Kamogawa-shi, Chiba, Japan, 296-8602
        • Kameda General Hospital /ID# 166906
      • Urayasu-shi, Chiba, Japan, 279-0021
        • Juntendo University Urayasu Hospital /ID# 162890
    • Ehime
      • Matsuyama-shi, Ehime, Japan, 791-8026
        • Saiseikai Matsuyama Hospital /ID# 169561
      • Saijo-shi, Ehime, Japan, 793-0027
        • Saiseikai Saijo Hospital /ID# 167705
      • Toon-shi, Ehime, Japan, 791-0295
        • Ehime University Hospital /ID# 162889
    • Fukui
      • Fukui-shi, Fukui, Japan, 918-8501
        • Fukui Red Cross Hospital /ID# 166907
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital /ID# 166900
      • Kitakyushu-shi, Fukuoka, Japan, 805-0061
        • Kitakyushu Yahata Higashi Hospital /ID# 213849
      • Kitakyusyu-shi, Fukuoka, Japan, 808-0024
        • Wakamatsu Hospital /ID# 160818
    • Fukushima
      • Fukushima-shi, Fukushima, Japan, 960-1295
        • Fukushima Medical University Hospital /ID# 169560
    • Gifu
      • Gifu-shi, Gifu, Japan, 500-8513
        • Gifu Municipal Hospital /ID# 207777
      • Gifu-shi, Gifu, Japan, 501-1194
        • Gifu University Hospital /ID# 207378
    • Gunma
      • Isesaki-shi, Gunma, Japan, 372-0006
        • Mihara Memorial /ID# 252885
      • Ota-shi, Gunma, Japan, 373-8585
        • SUBARU Health Insurance Society Ota Memorial Hospital /ID# 207778
      • Takasaki-shi, Gunma, Japan, 370-0829
        • National Hospital Organization Takasaki General Medical Center /ID# 207773
    • Hiroshima
      • Hiroshima-shi, Hiroshima, Japan, 730-8518
        • Hiroshima City Hiroshima Citizens Hospital /ID# 207126
    • Hokkaido
      • Asahikawa-shi, Hokkaido, Japan, 070-0061
        • Japanese Red Cross Asahikawa Hospital /ID# 207149
      • Asahikawa-shi, Hokkaido, Japan, 070-8644
        • National Hospital Organization Asahikawa Medical Center /ID# 155744
      • Date-shi, Hokkaido, Japan, 052-8511
        • Date Red Cross Hospital /ID# 207776
      • Hakodate-shi, Hokkaido, Japan, 041-8680
        • Hakodate Municipal Hospital /ID# 212304
      • Muroran-shi, Hokkaido, Japan, 050-0074
        • Muroran-Clinic /ID# 207780
      • Obihiro-shi, Hokkaido, Japan, 080-0024
        • Obihiro kosei Hospital /ID# 166904
      • Obihiro-shi, Hokkaido, Japan, 080-0833
        • Hokuto Hospital /ID# 207850
      • Sapporo-shi, Hokkaido, Japan, 060-8543
        • Sapporo Medical University Hospital /ID# 207373
      • Sapporo-shi, Hokkaido, Japan, 060-8604
        • Sapporo City General Hospital /ID# 212305
      • Sapporo-shi, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital /ID# 166902
      • Sapporo-shi, Hokkaido, Japan, 065-0021
        • Sapporo Neurology Hospital /ID# 207779
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 650-0015
        • Kobe Home Clinic of Neurology /ID# 212308
      • Kobe-shi, Hyogo, Japan, 650-0017
        • Kobe University Hospital /ID# 166895
      • Kobe-shi, Hyogo, Japan, 651-2273
        • Nishi-Kobe Medical Center /ID# 207781
      • Nishinomiya-shi, Hyogo, Japan, 663-8501
        • Hyogo Medical University Hospital /ID# 169562
      • Sanda-shi, Hyogo, Japan, 669-1592
        • Hyogo-Chuo National Hospital /ID# 207376
      • Tanbasasayama-shi, Hyogo, Japan, 669-2321
        • Hyogo College of Medicine Sasayama Medical Center /ID# 208716
    • Ibaraki
      • Ryugasaki-shi, Ibaraki, Japan, 301-0854
        • Ryugasaki Saiseikai Hospital /ID# 207846
      • Toride-shi, Ibaraki, Japan, 302-0022
        • JA Toride Medical Center /ID# 212302
    • Kagoshima
      • Aira-shi, Kagoshima, Japan, 899-5241
        • Minami Kyushu National Hospital /ID# 171052
      • Kagoshima-shi, Kagoshima, Japan, 890-0067
        • Okatsu Hospital /ID# 213489
      • Kagoshima-shi, Kagoshima, Japan, 890-8520
        • Kagoshima University Hospital /ID# 166909
      • Minamikyusyu-shi, Kagoshima, Japan, 8970215
        • Kikuno Hospital /ID# 207784
    • Kanagawa
      • Isehara-shi, Kanagawa, Japan, 259-1193
        • Tokai University Hospital /ID# 250954
      • Kawasaki-shi, Kanagawa, Japan, 216-8511
        • St. Marianna University Hospital /ID# 207119
      • Sagamihara-shi, Kanagawa, Japan, 252-0392
        • National Hospital Organization Sagamihara National Hospital /ID# 160825
      • Yokohama shi, Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center /ID# 165285
    • Kochi
      • Nankoku-shi, Kochi, Japan, 783-8505
        • Kochi Medical School Hospital /ID# 166903
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 602-8566
        • University Hospital Kyoto Prefectural University of Medicine /ID# 207130
      • Kyoto-shi, Kyoto, Japan, 606-8507
        • Kyoto University Hospital /ID# 162891
      • Kyoto-shi, Kyoto, Japan, 616-8255
        • National Hospital Organization Utano National Hospital /ID# 164139
    • Mie
      • Tsu-shi, Mie, Japan, 514-8507
        • Mie University Hospital /ID# 164140
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 9808574
        • Tohoku University Hospital /ID# 169557
      • Sendai-shi, Miyagi, Japan, 982-8555
        • NHO Sendai Nishitaga National Hospital /ID# 164977
      • Sendai-shi, Miyagi, Japan, 983-0005
        • Tohoku Medical and Pharmaceuti /ID# 169558
      • Sendai-shi, Miyagi, Japan, 983-8520
        • National Hospital Organization Sendai Medical Center /ID# 160831
    • Miyazaki
      • Kobayashi-shi, Miyazaki, Japan, 886-0004
        • Kobayashi City Hospital /ID# 208715
      • Miyakonojo-shi, Miyazaki, Japan, 885-0055
        • Fujimoto General Hospital /ID# 207150
    • Nagano
      • Matsumoto-shi, Nagano, Japan, 390-0814
        • Aizawa Hospital /ID# 212307
      • Matsumoto-shi, Nagano, Japan, 390-8621
        • Shinshu University Hospital /ID# 169559
    • Nagasaki
      • Nishisonogi-gun, Nagasaki, Japan, 851-2103
        • Nagasaki Kita Hospital /ID# 204353
    • Nara
      • Kashihara-shi, Nara, Japan, 634-8522
        • Nara Medical University Hospital /ID# 160830
      • Yoshino-gun, Nara, Japan, 638-0833
        • Minami-nara General Medical Center /ID# 207372
    • Niigata
      • Kashiwazaki-shi, Niigata, Japan, 945-8585
        • NHO Niigata National Hospital /ID# 204337
      • Nagaoka-shi, Niigata, Japan, 940-2085
        • Nagaoka Red Cross Hospital /ID# 212301
      • Niigata-shi, Niigata, Japan, 950-0983
        • Midori Hospital /ID# 207127
    • Oita
      • Oita-shi, Oita, Japan, 870-0855
        • Oita Prefectural Hospital /ID# 208714
    • Okayama
      • Okayama-shi, Okayama, Japan, 703-8265
        • Okayama Kyokuto Hospital /ID# 166892
    • Okinawa
      • Shimajiri-gun, Okinawa, Japan, 901-1105
        • Nanbu Medical Center / Nanbu Child Medical Center /ID# 207148
    • Osaka
      • Izumi-shi, Osaka, Japan, 594-0073
        • Izumi City General Hospital /ID# 207775
      • Kadoma-shi, Osaka, Japan, 571-0071
        • Kayashimaikuno Hospital /ID# 171051
      • Mino-shi, Osaka, Japan, 562-0014
        • Mino City Hospital /ID# 161765
      • Osaka-shi, Osaka, Japan, 530-0012
        • Osaka Saiseikai Nakatsu Hospital /ID# 168357
      • Osaka-shi, Osaka, Japan, 543-8555
        • Japanese Red Cross Osaka Hospital /ID# 207123
      • Sakai-shi, Osaka, Japan, 590-0132
        • Sakai Hospital Kinki Univ /ID# 166908
      • Suita-shi, Osaka, Japan, 565-0871
        • Osaka University Hospital /ID# 161764
    • Saitama
      • Ageo-shi, Saitama, Japan, 362-0057
        • Saitama Rihabilitation Center /ID# 168356
      • Saitama-shi, Saitama, Japan, 330-8503
        • Jichi Medical University Saitama Medical Center /ID# 207181
    • Shiga
      • Otsu-shi, Shiga, Japan, 520-2192
        • Shiga University of Medical Science Hospital /ID# 212306
    • Shimane
      • Matsue-shi, Shimane, Japan, 690-0015
        • NHO Matsue Medical Center /ID# 164135
    • Shizuoka
      • Fujieda-shi, Shizuoka, Japan, 8928512
        • Nanpuh Hospital /ID# 207128
      • Izunokuni-shi, Shizuoka, Japan, 410-2295
        • Juntendo University Shizuoka Hospital /ID# 207133
    • Tochigi
      • Ashikaga-shi, Tochigi, Japan, 326-0843
        • Japanese Red Cross Ashikaga Hospital /ID# 210476
      • Mooka-shi, Tochigi, Japan, 321-4337
        • Moka Chuo Clinic /ID# 213490
      • Shimotsuga-gun, Tochigi, Japan, 321-0293
        • Dokkyo Medical University Hospital /ID# 171050
    • Tokushima
      • Tokushima-shi, Tokushima, Japan, 770-0852
        • Itsuki Hospital /ID# 164138
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Juntendo University Hospital /ID# 160823
      • Bunkyo-ku, Tokyo, Japan, 113-8602
        • Nippon Medical School Hospital /ID# 207118
      • Kodaira-shi, Tokyo, Japan, 187-0031
        • National Center of Neurology and Psychiatry /ID# 160824
      • Minato-ku, Tokyo, Japan, 108-8329
        • Mita Hospital /ID# 207210
      • Nakano-ku, Tokyo, Japan, 164-0011
        • Nitobe Memorial Nakano General Hospital /ID# 207377
      • Ota-ku, Tokyo, Japan, 143-8541
        • Toho University Medical Center Omori Hospital /ID# 212271
      • Shibuya-ku, Tokyo, Japan, 150-8935
        • Japanese Red Cross Medical Center /ID# 207129
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Keio University Hospital /ID# 212267
      • Shinjuku-ku, Tokyo, Japan, 162-8666
        • Tokyo Women's Medical University Hospital /ID# 204350
    • Tottori
      • Yonago-shi, Tottori, Japan, 683-0846
        • Nomura Neuro Sleep Clinic /ID# 213491
      • Yonago-shi, Tottori, Japan, 683-8504
        • Tottori University Hospital /ID# 207124
    • Wakayama
      • Shingu-shi, Wakayama, Japan, 647-0072
        • Shingu Municipal Medical Center /ID# 207131
      • Wakayama-shi, Wakayama, Japan, 641-8510
        • Wakayama Medical University Hospital /ID# 160817
    • Yamaguchi
      • Shimonoseki-shi, Yamaguchi, Japan, 752-0985
        • National Hospital Organization Kanmon Medical Center /ID# 207370
      • Shunan-shi, Yamaguchi, Japan, 745-8522
        • Tokuyama Central Hospital /ID# 171049
      • Ube-shi, Yamaguchi, Japan, 755-8505
        • Yamaguchi University Hospital /ID# 207774
      • Yanai-shi, Yamaguchi, Japan, 742-1352
        • NHO Yanai Medical Center /ID# 164137
    • Yamanashi
      • Chuo-shi, Yamanashi, Japan, 409-3821
        • University of Yamanashi Hospital /ID# 207120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with Parkinson's Disease

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2016

Primary Completion (Estimated)

August 29, 2025

Study Completion (Estimated)

August 29, 2025

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

September 15, 2016

First Posted (Estimated)

September 20, 2016

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 26, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P15-720

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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