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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02906488
Recruitment Status : Recruiting
First Posted : September 20, 2016
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
The purpose of this study is to assess the safety and efficacy of long-term use of Duodopa in patients with Parkinson's disease in actual usage

Condition or disease
Parkinson's Disease (PD)

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Study Type : Observational
Estimated Enrollment : 512 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : September 12, 2016
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
Patients with Parkinson's Disease



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Time-dependent Change in Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 104 Weeks ]
    Motor evaluation

  3. 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).

  4. "Off" Period and "On" Period Accompanied by Dyskinesia 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906488


Contacts
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Contact: AbbVie GK Clinical Trial Registration Desk +81-3-4577-1111 abbvie_jpn_info_clingov@abbvie.com
Contact: Tomoyo Shimamoto 818049515110 tomoyo.shimamoto@abbvie.com

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Locations
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Japan
Nagoya City University Hospital /ID# 166893 Recruiting
Nagoya-shi, Aichi, Japan, 467-8602
Juntendo University Urayasu Hospital /ID# 162890 Recruiting
Urayasu Shi, Chiba, Japan, 279-0021
Fukuoka University Hospital /ID# 166900 Recruiting
Fukuoka-shi, Fukuoka, Japan, 814-0180
National Hospital Organization Asahikawa Medical Center /ID# 155744 Recruiting
Asahikawa, Hokkaido, Japan, 070-8644
Kobe University Hospital /ID# 166895 Recruiting
Kobe, Hyogo, Japan, 650-0017
Yokohama City Univ Medical Ctr /ID# 165285 Recruiting
Yokohama, Kanagawa, Japan, 232-0024
National Hospital Organization Utano National Hospital /ID# 164139 Recruiting
Kyoto City, Kyoto, Japan, 616-8255
Mie University Hospital /ID# 164140 Recruiting
Tsu-shi, Mie, Japan, 514-8507
Tohoku University Hospital /ID# 169557 Not yet recruiting
Sendai-shi, Miyagi, Japan, 980-8574
National Hospital Organization Sendai Medical Center /ID# 160831 Recruiting
Sendai-shi, Miyagi, Japan, 983-0045
NHO Sendai Nishitaga National Hospital /ID# 164977 Recruiting
Sendai, Miyagi, Japan, 982-8555
Shinshu University Hospital /ID# 169559 Not yet recruiting
Matsumoto-shi, Nagano, Japan, 〒390-8621
Osaka Saiseikai Nakatsu Hospital /ID# 168357 Recruiting
Osaka-shi, Osaka, Japan, 530-0012
Osaka University Hospital /ID# 161764 Recruiting
Suita-shi, Osaka, Japan, 565-0871
Dokkyo Medical University Hospital /ID# 171050 Not yet recruiting
Shimotsuga-gun, Tochigi, Japan, 321-0293
Saitama Rihabilitation Center /ID# 168356 Recruiting
Ageo, Japan, 362-0057
Minami Kyushu National Hospita /ID# 171052 Not yet recruiting
Aira, Japan, 899-5241
Aomori Prefectural Central Hos /ID# 165286 Recruiting
Aomori-shi, Japan, 030-8553
Saiseikai Saijo Hospital /ID# 167705 Recruiting
Ehime, Japan
Japanese Red Cross Fukui Hospi /ID# 166907 Recruiting
Fukui, Japan, 918-8011
Fukushima Med Univ Hosp /ID# 169560 Not yet recruiting
Fukushima-shi, Japan, 960-1295
Gifu Prefectural Genl Med Ctr /ID# 166894 Recruiting
Gifu, Japan, 500-8727
Higashiosaka City Medical Cent /ID# 166901 Recruiting
Higashiosaka, Japan, 578-0947
Himeji Central Hospital /ID# 164136 Recruiting
Himeji-shi, Japan
Ina Central Hospital /ID# 166905 Recruiting
INA, Japan, 396-0033
Kayashimaikuno Hospital /ID# 171051 Not yet recruiting
Kadoma, Japan, 571-0071
Kagoshima Uni Med and Dental /ID# 166909 Recruiting
Kagoshima, Japan, 890-8520
Kameda Medical Center /ID# 166906 Recruiting
Kamogawa, Japan, 296-8602
Nara Medical Univ Hospital /ID# 160830 Recruiting
Kashihara, Japan, 634-0813
Wakamatsu Hospital /ID# 160818 Recruiting
Kitakyusyu, Japan, 808-0024
National Center Hospital, NCNP /ID# 160824 Recruiting
Kodaira, Japan, 187-0031
NHO Matsue Medical Center /ID# 164135 Recruiting
Matsue, Japan, 690-0015
Saiseikai Matsuyama Hospital /ID# 169561 Not yet recruiting
Matsuyama, Japan, 791-8026
Mino City Hospital /ID# 161765 Recruiting
Mino-shi, Japan
Junwakai Memorial Hospital /ID# 164141 Recruiting
Miyazaki, Japan
Kochi Medical School Hospital /ID# 166903 Recruiting
Nankoku-shi, Japan, 783-8505
The Hospital of Hyogo College /ID# 169562 Not yet recruiting
Nishinomiya-shi, Japan, 663-8501
Obihiro Kosei General Hospital /ID# 166904 Recruiting
Obihiro, Japan, 080-0016
Okayama Kyokuto Hospital /ID# 166892 Recruiting
Okayama-shi, Japan, 703-8265
Sagamihara National Hospital /ID# 160825 Recruiting
Sagamihara, Japan, 252-0315
Sakai Hospital Kinki Univ /ID# 166908 Recruiting
Sakai-shi, Japan, 590-0132
Kyoto University Hospital /ID# 162891 Recruiting
Sakyo-ku, Japan, 606-8507
Hokkaido Medical Center /ID# 161763 Recruiting
Sapporo-shi, Japan
Hokkaido University Hospital /ID# 166902 Recruiting
Sapporo, Japan, 060-8648
Tohoku Medical and Pharmaceuti /ID# 169558 Not yet recruiting
Sendai, Japan, 983-0005
Tokuyama Central Hospital /ID# 171049 Not yet recruiting
Shunan-shi, Japan, 745-8522
Itsuki Hospital /ID# 164138 Recruiting
Tokushima, Japan, 770-0852
Juntendo University Hospital /ID# 160823 Recruiting
Tokyo, Japan, 113-8431
Ehime University Hospital /ID# 162889 Recruiting
Toon, Japan, 791-0204
Toyota Memorial Hospital /ID# 166891 Recruiting
Toyota, Japan, 471-8513
Wakayama Medical University /ID# 160817 Recruiting
Wakayama, Japan, 641-8510
NHO Yanai Medical Center /ID# 164137 Recruiting
Yanai, Japan, 742-1352
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02906488     History of Changes
Other Study ID Numbers: P15-720
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by AbbVie:
Quality of life
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Carbidopa, levodopa drug combination
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action