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

NCT02906488 | Completed

• 1 other identifier: P15-720
• Study Type: observational
• Target: 839
• Locations: 1 country
• Sites: 127

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

Conditions

Parkinson's Disease

Keywords

Quality of life

Outcome Measures

Primary Outcomes (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.

  104 weeks

Secondary Outcomes (5)

• Time-dependent Change in "Off" Time and "On" Time Accompanied By Dyskinesia Interfering with Daily Activities

  104 Weeks

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

  104 Weeks

• Time-dependent Change in Parkinson's Disease Questionnaire - 8 Items (PDQ-8)

  104 weeks

• "Off" Period and "On" Period Accompanied by Dyskenesia Interfering with Daily Activities by Patient Characteristic Factor

  104 weeks

• Time-dependent Change in Parkinson's Disease Quality of Life Questionnaire - Carers (PDQ-Carer)

  104 weeks

Study Arms (1)

Patients with Parkinson's Disease

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (127)

Nagoya University Hospital /ID# 212303

Nagoya, Aichi-ken, 466-8560, Japan

Location

Nagoya City University Hospital /ID# 166893

Nagoya, Aichi-ken, 467-8602, Japan

Location

Toyota Memorial Hospital /ID# 166891

Toyota-shi, Aichi-ken, 471-8513, Japan

Location

Akita City Hospital /ID# 207121

Akita, Akita, 010-0933, Japan

Location

National Hospital Organization Akita National Hospital /ID# 207374

Yurihonjo-shi, Akita, 018-1301, Japan

Location

Aomori Prefectural Central Hospital /ID# 165286

Aomori, Aomori, 030-8553, Japan

Location

Kameda General Hospital /ID# 166906

Kamogawa-shi, Chiba, 296-8602, Japan

Location

Juntendo University Urayasu Hospital /ID# 162890

Urayasu-shi, Chiba, 279-0021, Japan

Location

Saiseikai Matsuyama hospital /ID# 169561

Matsuyama, Ehime, 791-8026, Japan

Location

Saiseikai Saijo Hospital /ID# 167705

Saijo-shi, Ehime, 793-0027, Japan

Location

Ehime University Hospital /ID# 162889

Toon-shi, Ehime, 791-0295, Japan

Location

Fukui Red Cross Hospital /ID# 166907

Fukui-shi, Fukui, 918-8501, Japan

Location

Fukuoka University Hospital /ID# 166900

Fukuoka, Fukuoka, 814-0180, Japan

Location

Kitakyushu Yahata Higashi Hospital /ID# 213849

Kitakyushu-shi, Fukuoka, 805-0061, Japan

Location

Wakamatsu Hospital /ID# 160818

Kitakyusyu-shi, Fukuoka, 808-0024, Japan

Location

Fukushima Medical University Hospital /ID# 169560

Fukushima, Fukushima, 960-1295, Japan

Location

Gifu Municipal Hospital /ID# 207777

Gifu, Gifu, 500-8323, Japan

Location

Gifu Prefectural General Medical Center /ID# 166894

Gifu, Gifu, 500-8727, Japan

Location

Gifu University Hospital /ID# 207378

Gifu, Gifu, 501-1194, Japan

Location

Mihara Memorial /ID# 252885

Isesaki-shi, Gunma, 372-0006, Japan

Location

SUBARU Health Insurance Society Ota Memorial Hospital /ID# 207778

Ota-shi, Gunma, 373-8585, Japan

Location

National Hospital Organization Takasaki General Medical Center /ID# 207773

Takasaki-shi, Gunma, 370-0829, Japan

Location

Hiroshima City Hiroshima Citizens Hospital /ID# 207126

Hiroshima, Hiroshima, 730-8518, Japan

Location

Hiroshima Teishin Hospital /ID# 245072

Hiroshima, Hiroshima, 730-8798, Japan

Location

Hiroshima University Hospital /ID# 212269

Hiroshima, Hiroshima, 734-8551, Japan

Location

Japanese Red Cross Asahikawa Hospital /ID# 207149

Asahikawa-shi, Hokkaido, 070-0061, Japan

Location

National Hospital Organization Asahikawa Medical Center /ID# 155744

Asahikawa-shi, Hokkaido, 070-8644, Japan

Location

Date Red Cross Hospital /ID# 207776

Date-shi, Hokkaido, 052-8511, Japan

Location

Hakodate Municipal Hospital /ID# 212304

Hakodate-shi, Hokkaido, 041-8680, Japan

Location

Muroran-Clinic /ID# 207780

Muroran-shi, Hokkaido, 050-0074, Japan

Location

Obihiro kosei Hospital /ID# 166904

Obihiro-shi, Hokkaido, 080-0024, Japan

Location

Hokuto Hospital /ID# 207850

Obihiro-shi, Hokkaido, 080-0833, Japan

Location

Sapporo Medical University Hospital /ID# 207373

Sapporo, Hokkaido, 060-8543, Japan

Location

Sapporo City General Hospital /ID# 212305

Sapporo, Hokkaido, 060-8604, Japan

Location

Hokkaido University Hospital /ID# 166902

Sapporo, Hokkaido, 060-8648, Japan

Location

Hokkaido Medical Center /ID# 161763

Sapporo, Hokkaido, 063-0005, Japan

Location

Sapporo Neurology Hospital /ID# 207779

Sapporo, Hokkaido, 065-0021, Japan

Location

Himeji Central Hospital /ID# 164136

Himeji-shi, Hyōgo, 672-8501, Japan

Location

Kobe Home Clinic of Neurology /ID# 212308

Kobe, Hyōgo, 650-0015, Japan

Location

Kobe University Hospital /ID# 166895

Kobe, Hyōgo, 650-0017, Japan

Location

Nishi-Kobe Medical Center /ID# 207781

Kobe, Hyōgo, 651-2273, Japan

Location

Hyogo Medical University Hospital /ID# 169562

Nishinomiya-shi, Hyōgo, 663-8501, Japan

Location

Hyogo-Chuo National Hospital /ID# 207376

Sanda-shi, Hyōgo, 669-1592, Japan

Location

Hyogo College of Medicine Sasayama Medical Center /ID# 208716

Tanbasasayama-shi, Hyōgo, 669-2321, Japan

Location

Toyooka Hospital /ID# 212270

Toyooka-shi, Hyōgo, 668-8501, Japan

Location

Ryugasaki Saiseikai Hospital /ID# 207846

Ryugasaki-shi, Ibaraki, 301-0854, Japan

Location

JA Toride Medical Center /ID# 212302

Toride-shi, Ibaraki, 302-0022, Japan

Location

Iwate Medical University Uchimaru Medical Center /ID# 212265

Morioka, Iwate, 020-8505, Japan

Location

Minami Kyushu National Hospital /ID# 171052

Aira-shi, Kagoshima-ken, 899-5241, Japan

Location

Okatsu Hospital /ID# 213489

Kagoshima, Kagoshima-ken, 890-0067, Japan

Location

Kagoshima University Hospital /ID# 166909

Kagoshima, Kagoshima-ken, 890-8520, Japan

Location

Kikuno Hospital /ID# 207784

Minamikyusyu-shi, Kagoshima-ken, 8970215, Japan

Location

Tokai University Hospital /ID# 250954

Isehara, Kanagawa, 259-1193, Japan

Location

St Marianna University School Of Medicine /ID# 204347

Kawasaki-shi, Kanagawa, 216-8511, Japan

Location

St Marianna University School Of Medicine /ID# 207119

Kawasaki-shi, Kanagawa, 216-8511, Japan

Location

National Hospital Organization Sagamihara National Hospital /ID# 160825

Sagamihara-shi, Kanagawa, 252-0392, Japan

Location

Yokohama City University Medical Center /ID# 165285

Yokohama, Kanagawa, 232-0024, Japan

Location

Kochi Medical School Hospital /ID# 166903

Nankoku-shi, Kochi, 783-8505, Japan

Location

Kumamoto Saishunso National Hospital /ID# 212813

Kōshi, Kumamoto, 861-1102, Japan

Location

University Hospital Kyoto Prefectural University of Medicine /ID# 207130

Kyoto, Kyoto, 602-8566, Japan

Location

Kyoto University Hospital /ID# 162891

Kyoto, Kyoto, 606-8507, Japan

Location

National Hospital Organization Utano National Hospital /ID# 164139

Kyoto, Kyoto, 616-8255, Japan

Location

Mie University Hospital /ID# 164140

Tsu, Mie-ken, 514-8507, Japan

Location

Tohoku University Hospital /ID# 169557

Sendai, Miyagi, 9808574, Japan

Location

NHO Sendai Nishitaga National Hospital /ID# 164977

Sendai, Miyagi, 982-8555, Japan

Location

Tohoku Medical and Pharmaceuti /ID# 169558

Sendai, Miyagi, 983-0005, Japan

Location

National Hospital Organization Sendai Medical Center /ID# 160831

Sendai, Miyagi, 983-8520, Japan

Location

Kobayashi City Hospital /ID# 208715

Kobayashi-shi, Miyazaki, 886-0004, Japan

Location

Fujimoto General Hospital /ID# 207150

Miyakonojo-shi, Miyazaki, 885-0055, Japan

Location

Ina Central Hospital /ID# 166905

Ina-shi, Nagano, 396-0033, Japan

Location

Aizawa Hospital /ID# 212307

Matsumoto-shi, Nagano, 390-0814, Japan

Location

Shinshu University Hospital /ID# 169559

Matsumoto-shi, Nagano, 390-8621, Japan

Location

Nagasaki Kita Hospital /ID# 204353

Nishisonogi-gun, Nagasaki, 851-2103, Japan

Location

Nara Medical University Hospital /ID# 160830

Kashihara-shi, Nara, 634-8522, Japan

Location

Minami Nara General Medical Center /ID# 207372

Yoshino-gun, Nara, 638-8551, Japan

Location

NHO Niigata National Hospital /ID# 204337

Kashiwazaki-shi, Niigata, 945-8585, Japan

Location

Nagaoka Red Cross Hospital /ID# 212301

Nagaoka-shi, Niigata, 940-2085, Japan

Location

Midori Hospital /ID# 207127

Niigata, Niigata, 950-0983, Japan

Location

Oita Prefectural Hospital /ID# 208714

Ōita, Oita Prefecture, 870-0855, Japan

Location

Japanese Red Cross Okayama Hospital /ID# 212268

Okayama, Okayama-ken, 700-8607, Japan

Location

Okayama Kyokuto Hospital /ID# 166892

Okayama, Okayama-ken, 703-8265, Japan

Location

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

Shimajiri-gun, Okinawa, 901-1105, Japan

Location

Higashiosaka City Medical Center /ID# 166901

Higashiosaka-shi, Osaka, 578-8588, Japan

Location

Izumi City General Hospital /ID# 207775

Izumi-shi, Osaka, 594-0073, Japan

Location

Kayashimaikuno Hospital /ID# 171051

Kadoma-shi, Osaka, 571-0071, Japan

Location

Mino City Hospital /ID# 161765

Minoh, Osaka, 562-0014, Japan

Location

Osaka Saiseikai Nakatsu Hospital /ID# 168357

Osaka, Osaka, 530-0012, Japan

Location

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

Osaka, Osaka, 530-8480, Japan

Location

Japanese Red Cross Osaka Hospital /ID# 207123

Osaka, Osaka, 543-8555, Japan

Location

Kinki University Sakai Hospital /ID# 166908

Sakai-shi, Osaka, 590-0132, Japan

Location

The University of Osaka Hospital /ID# 161764

Suita-shi, Osaka, 565-0871, Japan

Location

Saitama Rihabilitation Center /ID# 168356

Ageo-shi, Saitama, 362-0057, Japan

Location

Jichi Medical University Saitama Medical Center /ID# 207181

Saitama-shi, Saitama, 330-8503, Japan

Location

Kamiya Clinic /ID# 261328

Soka-shi, Saitama, 340-0017, Japan

Location

Shiga University of Medical Science Hospital /ID# 212306

Ōtsu, Shiga, 520-2192, Japan

Location

NHO Matsue Medical Center /ID# 164135

Matsue, Shimane, 690-0015, Japan

Location

Nanpuh Hospital /ID# 207128

Fujieda-shi, Shizuoka, 8928512, Japan

Location

Seirei Hamamatsu General Hospital /ID# 212266

Hamamatsu, Shizuoka, 430-8558, Japan

Location

Juntendo University Shizuoka Hospital /ID# 207133

Izunokuni-shi, Shizuoka, 410-2295, Japan

Location

Japanese Red Cross Ashikaga Hospital /ID# 210476

Ashikaga-shi, Tochigi, 326-0843, Japan

Location

Dokkyo Medical University Hospital /ID# 171050

Mibu, Tochigi, 321-0293, Japan

Location

Moka Chuo Clinic /ID# 213490

Mooka-shi, Tochigi, 321-4337, Japan

Location

Mino Tanaka Hospital /ID# 212272

Miyoshi-shi, Tokushima, 470-0224, Japan

Location

Itsuki Hospital /ID# 164138

Tokushima, Tokushima, 770-0852, Japan

Location

Juntendo University Hospital /ID# 160823

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

Nippon Medical School Hospital /ID# 204339

Bunkyo-ku, Tokyo, 113-8603, Japan

Location

Nippon Medical School Hospital /ID# 207118

Bunkyo-ku, Tokyo, 113-8603, Japan

Location

National Center of Neurology and Psychiatry /ID# 160824

Kodaira-shi, Tokyo, 187-0031, Japan

Location

Juntendo Tokyo Koto Geriatric Medical Center /ID# 260157

Koto-ku, Tokyo, 136-0075, Japan

Location

Mita Hospital /ID# 207210

Minato-ku, Tokyo, 108-8329, Japan

Location

Nitobe Memorial Nakano General Hospital /ID# 207377

Nakano-ku, Tokyo, 164-0011, Japan

Location

Toho University Medical Center Omori Hospital /ID# 212271

Ōta-ku, Tokyo, 143-8541, Japan

Location

Japanese Red Cross Medical Center /ID# 207129

Shibuya-ku, Tokyo, 150-8935, Japan

Location

Keio University Hospital /ID# 212267

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

Tokyo Women's Medical University Hospital /ID# 204350

Shinjuku-ku, Tokyo, 162-8666, Japan

Location

Nomura Neuro Sleep Clinic /ID# 213491

Yonago-shi, Tottori, 683-0846, Japan

Location

Tottori University Hospital /ID# 207124

Yonago-shi, Tottori, 683-8504, Japan

Location

Shingu Municipal Medical Center /ID# 207131

Shingu-shi, Wakayama, 647-0072, Japan

Location

Wakayama Medical University Hospital /ID# 160817

Wakayama, Wakayama, 641-8510, Japan

Location

Nihonkai General Hospital /ID# 207196

Sakata-shi, Yamagata, 998-0828, Japan

Location

National Hospital Organization Kanmon Medical Center /ID# 207370

Shimonoseki-shi, Yamaguchi, 752-0985, Japan

Location

Tokuyama Central Hospital /ID# 171049

Shunan-shi, Yamaguchi, 745-8522, Japan

Location

Yamaguchi University Hospital /ID# 207774

Ube-shi, Yamaguchi, 755-8505, Japan

Location

NHO Yanai Medical Center /ID# 164137

Yanai-shi, Yamaguchi, 742-1352, Japan

Location

University of Yamanashi Hospital /ID# 207120

Chuo-shi, Yamanashi, 409-3898, Japan

Location

Junwakai Memorial Hospital /ID# 164141

Miyazaki, 880-2112, Japan

Location

Tachikawa Hospital /ID# 207182

Tachikawa, Japan

Location

Related Links

• Related Info.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: September 20, 2016
• Study Start: September 12, 2016
• Primary Completion: July 24, 2025
• Study Completion: July 24, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

JP (127)