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Parkinson's DiseaseNCT02906488

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

An observational study of Parkinson's Disease, run by AbbVie at 127 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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 Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Parkinson's Disease
How many people
839 participants
Where
127 sitesJapan
Study dates
12 Sep 2016to 24 Jul 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • NA

Trial locations and contacts

127 sites in 1 country.

127 sites in 1 country

Japan127 sites

  • Saitama Rihabilitation Center /ID# 168356

    Ageo-shi, Saitama, 362-0057

  • Minami Kyushu National Hospital /ID# 171052

    Aira-shi, Kagoshima-ken, 899-5241

  • Akita City Hospital /ID# 207121

    Akita, Akita, 010-0933

  • Aomori Prefectural Central Hospital /ID# 165286

    Aomori, Aomori, 030-8553

  • Japanese Red Cross Asahikawa Hospital /ID# 207149

    Asahikawa-shi, Hokkaido, 070-0061

  • National Hospital Organization Asahikawa Medical Center /ID# 155744

    Asahikawa-shi, Hokkaido, 070-8644

  • Japanese Red Cross Ashikaga Hospital /ID# 210476

    Ashikaga-shi, Tochigi, 326-0843

  • Juntendo University Hospital /ID# 160823

    Bunkyo-ku, Tokyo, 113-8431

  • Nippon Medical School Hospital /ID# 204339

    Bunkyo-ku, Tokyo, 113-8603

  • Nippon Medical School Hospital /ID# 207118

    Bunkyo-ku, Tokyo, 113-8603

  • University of Yamanashi Hospital /ID# 207120

    Chuo-shi, Yamanashi, 409-3898

  • Date Red Cross Hospital /ID# 207776

    Date-shi, Hokkaido, 052-8511

  • Nanpuh Hospital /ID# 207128

    Fujieda-shi, Shizuoka, 8928512

  • Fukui Red Cross Hospital /ID# 166907

    Fukui-shi, Fukui, 918-8501

  • Fukuoka University Hospital /ID# 166900

    Fukuoka, Fukuoka, 814-0180

  • Fukushima Medical University Hospital /ID# 169560

    Fukushima, Fukushima, 960-1295

  • Gifu Municipal Hospital /ID# 207777

    Gifu, Gifu, 500-8323

  • Gifu Prefectural General Medical Center /ID# 166894

    Gifu, Gifu, 500-8727

  • Gifu University Hospital /ID# 207378

    Gifu, Gifu, 501-1194

  • Hakodate Municipal Hospital /ID# 212304

    Hakodate-shi, Hokkaido, 041-8680

  • Seirei Hamamatsu General Hospital /ID# 212266

    Hamamatsu, Shizuoka, 430-8558

  • Higashiosaka City Medical Center /ID# 166901

    Higashiosaka-shi, Osaka, 578-8588

  • Himeji Central Hospital /ID# 164136

    Himeji-shi, Hyōgo, 672-8501

  • Hiroshima City Hiroshima Citizens Hospital /ID# 207126

    Hiroshima, Hiroshima, 730-8518

  • Hiroshima Teishin Hospital /ID# 245072

    Hiroshima, Hiroshima, 730-8798

  • Hiroshima University Hospital /ID# 212269

    Hiroshima, Hiroshima, 734-8551

  • Ina Central Hospital /ID# 166905

    Ina-shi, Nagano, 396-0033

  • Tokai University Hospital /ID# 250954

    Isehara, Kanagawa, 259-1193

  • Mihara Memorial /ID# 252885

    Isesaki-shi, Gunma, 372-0006

  • Izumi City General Hospital /ID# 207775

    Izumi-shi, Osaka, 594-0073

  • Juntendo University Shizuoka Hospital /ID# 207133

    Izunokuni-shi, Shizuoka, 410-2295

  • Kayashimaikuno Hospital /ID# 171051

    Kadoma-shi, Osaka, 571-0071

  • Okatsu Hospital /ID# 213489

    Kagoshima, Kagoshima-ken, 890-0067

  • Kagoshima University Hospital /ID# 166909

    Kagoshima, Kagoshima-ken, 890-8520

  • Kameda General Hospital /ID# 166906

    Kamogawa-shi, Chiba, 296-8602

  • Nara Medical University Hospital /ID# 160830

    Kashihara-shi, Nara, 634-8522

  • NHO Niigata National Hospital /ID# 204337

    Kashiwazaki-shi, Niigata, 945-8585

  • St Marianna University School Of Medicine /ID# 204347

    Kawasaki-shi, Kanagawa, 216-8511

  • St Marianna University School Of Medicine /ID# 207119

    Kawasaki-shi, Kanagawa, 216-8511

  • Kitakyushu Yahata Higashi Hospital /ID# 213849

    Kitakyushu-shi, Fukuoka, 805-0061

  • Wakamatsu Hospital /ID# 160818

    Kitakyusyu-shi, Fukuoka, 808-0024

  • Kobayashi City Hospital /ID# 208715

    Kobayashi-shi, Miyazaki, 886-0004

  • Kobe Home Clinic of Neurology /ID# 212308

    Kobe, Hyōgo, 650-0015

  • Kobe University Hospital /ID# 166895

    Kobe, Hyōgo, 650-0017

  • Nishi-Kobe Medical Center /ID# 207781

    Kobe, Hyōgo, 651-2273

  • National Center of Neurology and Psychiatry /ID# 160824

    Kodaira-shi, Tokyo, 187-0031

  • Kumamoto Saishunso National Hospital /ID# 212813

    Kōshi, Kumamoto, 861-1102

  • Juntendo Tokyo Koto Geriatric Medical Center /ID# 260157

    Koto-ku, Tokyo, 136-0075

  • University Hospital Kyoto Prefectural University of Medicine /ID# 207130

    Kyoto, Kyoto, 602-8566

  • Kyoto University Hospital /ID# 162891

    Kyoto, Kyoto, 606-8507

  • National Hospital Organization Utano National Hospital /ID# 164139

    Kyoto, Kyoto, 616-8255

  • NHO Matsue Medical Center /ID# 164135

    Matsue, Shimane, 690-0015

  • Aizawa Hospital /ID# 212307

    Matsumoto-shi, Nagano, 390-0814

  • Shinshu University Hospital /ID# 169559

    Matsumoto-shi, Nagano, 390-8621

  • Saiseikai Matsuyama hospital /ID# 169561

    Matsuyama, Ehime, 791-8026

  • Dokkyo Medical University Hospital /ID# 171050

    Mibu, Tochigi, 321-0293

  • Kikuno Hospital /ID# 207784

    Minamikyusyu-shi, Kagoshima-ken, 8970215

  • Mita Hospital /ID# 207210

    Minato-ku, Tokyo, 108-8329

  • Mino City Hospital /ID# 161765

    Minoh, Osaka, 562-0014

  • Fujimoto General Hospital /ID# 207150

    Miyakonojo-shi, Miyazaki, 885-0055

  • Junwakai Memorial Hospital /ID# 164141

    Miyazaki, 880-2112

  • Mino Tanaka Hospital /ID# 212272

    Miyoshi-shi, Tokushima, 470-0224

  • Moka Chuo Clinic /ID# 213490

    Mooka-shi, Tochigi, 321-4337

  • Iwate Medical University Uchimaru Medical Center /ID# 212265

    Morioka, Iwate, 020-8505

  • Muroran-Clinic /ID# 207780

    Muroran-shi, Hokkaido, 050-0074

  • Nagaoka Red Cross Hospital /ID# 212301

    Nagaoka-shi, Niigata, 940-2085

  • Nagoya University Hospital /ID# 212303

    Nagoya, Aichi-ken, 466-8560

  • Nagoya City University Hospital /ID# 166893

    Nagoya, Aichi-ken, 467-8602

  • Nitobe Memorial Nakano General Hospital /ID# 207377

    Nakano-ku, Tokyo, 164-0011

  • Kochi Medical School Hospital /ID# 166903

    Nankoku-shi, Kochi, 783-8505

  • Midori Hospital /ID# 207127

    Niigata, Niigata, 950-0983

  • Hyogo Medical University Hospital /ID# 169562

    Nishinomiya-shi, Hyōgo, 663-8501

  • Nagasaki Kita Hospital /ID# 204353

    Nishisonogi-gun, Nagasaki, 851-2103

  • Obihiro kosei Hospital /ID# 166904

    Obihiro-shi, Hokkaido, 080-0024

  • Hokuto Hospital /ID# 207850

    Obihiro-shi, Hokkaido, 080-0833

  • Oita Prefectural Hospital /ID# 208714

    Ōita, Oita Prefecture, 870-0855

  • Japanese Red Cross Okayama Hospital /ID# 212268

    Okayama, Okayama-ken, 700-8607

  • Okayama Kyokuto Hospital /ID# 166892

    Okayama, Okayama-ken, 703-8265

  • Osaka Saiseikai Nakatsu Hospital /ID# 168357

    Osaka, Osaka, 530-0012

  • Kitano Hospital, Tazuke Kofukai Medical Research Institute /ID# 259507

    Osaka, Osaka, 530-8480

  • Japanese Red Cross Osaka Hospital /ID# 207123

    Osaka, Osaka, 543-8555

  • Toho University Medical Center Omori Hospital /ID# 212271

    Ōta-ku, Tokyo, 143-8541

  • SUBARU Health Insurance Society Ota Memorial Hospital /ID# 207778

    Ota-shi, Gunma, 373-8585

  • Shiga University of Medical Science Hospital /ID# 212306

    Ōtsu, Shiga, 520-2192

  • Ryugasaki Saiseikai Hospital /ID# 207846

    Ryugasaki-shi, Ibaraki, 301-0854

  • National Hospital Organization Sagamihara National Hospital /ID# 160825

    Sagamihara-shi, Kanagawa, 252-0392

  • Saiseikai Saijo Hospital /ID# 167705

    Saijo-shi, Ehime, 793-0027

  • Jichi Medical University Saitama Medical Center /ID# 207181

    Saitama-shi, Saitama, 330-8503

  • Kinki University Sakai Hospital /ID# 166908

    Sakai-shi, Osaka, 590-0132

  • Nihonkai General Hospital /ID# 207196

    Sakata-shi, Yamagata, 998-0828

  • Hyogo-Chuo National Hospital /ID# 207376

    Sanda-shi, Hyōgo, 669-1592

  • Sapporo Medical University Hospital /ID# 207373

    Sapporo, Hokkaido, 060-8543

  • Sapporo City General Hospital /ID# 212305

    Sapporo, Hokkaido, 060-8604

  • Hokkaido University Hospital /ID# 166902

    Sapporo, Hokkaido, 060-8648

  • Hokkaido Medical Center /ID# 161763

    Sapporo, Hokkaido, 063-0005

  • Sapporo Neurology Hospital /ID# 207779

    Sapporo, Hokkaido, 065-0021

  • Tohoku University Hospital /ID# 169557

    Sendai, Miyagi, 9808574

  • NHO Sendai Nishitaga National Hospital /ID# 164977

    Sendai, Miyagi, 982-8555

  • Tohoku Medical and Pharmaceuti /ID# 169558

    Sendai, Miyagi, 983-0005

  • National Hospital Organization Sendai Medical Center /ID# 160831

    Sendai, Miyagi, 983-8520

  • Japanese Red Cross Medical Center /ID# 207129

    Shibuya-ku, Tokyo, 150-8935

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

    Shimajiri-gun, Okinawa, 901-1105

  • National Hospital Organization Kanmon Medical Center /ID# 207370

    Shimonoseki-shi, Yamaguchi, 752-0985

  • Shingu Municipal Medical Center /ID# 207131

    Shingu-shi, Wakayama, 647-0072

  • Keio University Hospital /ID# 212267

    Shinjuku-ku, Tokyo, 160-8582

  • Tokyo Women's Medical University Hospital /ID# 204350

    Shinjuku-ku, Tokyo, 162-8666

  • Tokuyama Central Hospital /ID# 171049

    Shunan-shi, Yamaguchi, 745-8522

  • Kamiya Clinic /ID# 261328

    Soka-shi, Saitama, 340-0017

  • The University of Osaka Hospital /ID# 161764

    Suita-shi, Osaka, 565-0871

  • Tachikawa Hospital /ID# 207182

    Tachikawa

  • National Hospital Organization Takasaki General Medical Center /ID# 207773

    Takasaki-shi, Gunma, 370-0829

  • Hyogo College of Medicine Sasayama Medical Center /ID# 208716

    Tanbasasayama-shi, Hyōgo, 669-2321

  • Itsuki Hospital /ID# 164138

    Tokushima, Tokushima, 770-0852

  • Ehime University Hospital /ID# 162889

    Toon-shi, Ehime, 791-0295

  • JA Toride Medical Center /ID# 212302

    Toride-shi, Ibaraki, 302-0022

  • Toyooka Hospital /ID# 212270

    Toyooka-shi, Hyōgo, 668-8501

  • Toyota Memorial Hospital /ID# 166891

    Toyota-shi, Aichi-ken, 471-8513

  • Mie University Hospital /ID# 164140

    Tsu, Mie-ken, 514-8507

  • Yamaguchi University Hospital /ID# 207774

    Ube-shi, Yamaguchi, 755-8505

  • Juntendo University Urayasu Hospital /ID# 162890

    Urayasu-shi, Chiba, 279-0021

  • Wakayama Medical University Hospital /ID# 160817

    Wakayama, Wakayama, 641-8510

  • NHO Yanai Medical Center /ID# 164137

    Yanai-shi, Yamaguchi, 742-1352

  • Yokohama City University Medical Center /ID# 165285

    Yokohama, Kanagawa, 232-0024

  • Nomura Neuro Sleep Clinic /ID# 213491

    Yonago-shi, Tottori, 683-0846

  • Tottori University Hospital /ID# 207124

    Yonago-shi, Tottori, 683-8504

  • Minami Nara General Medical Center /ID# 207372

    Yoshino-gun, Nara, 638-8551

  • National Hospital Organization Akita National Hospital /ID# 207374

    Yurihonjo-shi, Akita, 018-1301

Other trials in Japan

About this study

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

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

Keywords
Quality of life
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02906488
Study groupRoleWhat they receive
Patients with Parkinson's DiseaseNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 104 weeks

Secondary outcomes (5)

  1. 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.

    Measured: 104 Weeks

  2. Time-dependent Change in Unified Parkinson's Disease Rating Scale (UPDRS)

    Motor evaluation

    Measured: 104 Weeks

  3. 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).

    Measured: 104 weeks

  4. "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.

    Measured: 104 weeks

  5. 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.

    Measured: 104 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2016 (estimated)
  2. Study start12 Sep 2016
  3. Primary completion24 Jul 2025
  4. Study completion24 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
839 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02906488
Sponsor's protocol ID
P15-720
Status last verified
Aug 2025
First submitted
12 Sep 2016
Last updated
24 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson's Disease, run by AbbVie at 127 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 127 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in "Off" Periods From Start of Treatment to Week 104 (time frame: 104 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02906488.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.

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