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

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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

Tracking Information
First Submitted Date September 12, 2016
First Posted Date September 20, 2016
Last Update Posted Date June 19, 2019
Actual Study Start Date September 12, 2016
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 15, 2016)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02906488 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 15, 2018)
  • 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.
  • Time-dependent Change in Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 104 Weeks ]
    Motor evaluation
  • 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).
  • "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.
  • 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.
Original Secondary Outcome Measures
 (submitted: September 15, 2016)
  • 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.
  • Time-dependent Change in Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 104 Weeks ]
    Motor evaluation
  • 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).
  • 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.
  • "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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Special Drug Use-results Survey of Duodopa Enteral Solution in Patients With Parkinson's Disease
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
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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Parkinson's Disease (PD)
Intervention Not Provided
Study Groups/Cohorts Patients with Parkinson's Disease
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 17, 2019)
512
Original Estimated Enrollment
 (submitted: September 15, 2016)
150
Estimated Study Completion Date January 31, 2021
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT02906488
Other Study ID Numbers P15-720
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party AbbVie
Study Sponsor AbbVie
Collaborators Not Provided
Investigators
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date June 2019