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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 July 2024 |
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Main ID: |
NCT04379050 |
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Date of registration:
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01/05/2020 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's Disease
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Scientific title:
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An Open-label Extension of Study M15-741 to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's Disease |
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Date of first enrolment:
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June 8, 2020 |
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Target sample size:
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130 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT04379050 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Belgium
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Canada
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Denmark
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Germany
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Italy
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Japan
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Netherlands
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Russian Federation
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Spain
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Sweden
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United Kingdom
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United States
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Contacts
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Name:
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ABBVIE INC. |
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Address:
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Telephone:
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Email:
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Affiliation:
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AbbVie |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Participants who have Parkinson's Disease and who have successfully completed the
parent study M15-741.
- Participants willing and able to comply with procedures required in the protocol.
Exclusion Criteria:
- Participants, if judged by the investigator to be unsuitable candidates to continue
to receive ABBV-951 for any reason.
Age minimum:
30 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease (PD)
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Intervention(s)
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Drug: ABBV-951
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Primary Outcome(s)
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Percentage Of Participants With Letter Grade Equal To Or Higher Than D On The Infusion Site Evaluation Scale
[Time Frame: Up To Week 96]
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Percentage Of Participants With Numeric Grade Equal To Or Higher Than 5 On The Infusion Site Evaluation Scale
[Time Frame: Up To Week 96]
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Percentage of Participants With Adverse Events (AE)
[Time Frame: Up To Week 96]
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Change From Baseline in Electrocardiograms (ECGs)
[Time Frame: Up To Week 96]
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Change in Vital Signs Measurements
[Time Frame: Up To Week 96]
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Change in Clinical Laboratory Test Data
[Time Frame: Up To Week 96]
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Secondary Outcome(s)
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Average Normalized Daily "On" Time
[Time Frame: Up To Week 96]
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Cognitive Impairment Measurement
[Time Frame: Up To Week 96]
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Average Normalized Daily "Off" Time
[Time Frame: Up To Week 96]
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Change From Baseline in Health-related Quality Of Life Measurement as Assessed by EuroQol 5-dimensions questionnaire (EQ-5D-5L)
[Time Frame: Up To Week 96]
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Parkinson's Disease (PD) Symptoms Measurement
[Time Frame: Up To Week 96]
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Change From Baseline in Quality Of Life Measurement as Assessed by PD Questionnaire-39 (PDQ-39)
[Time Frame: Up To Week 96]
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Secondary ID(s)
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2019-004235-23
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M15-737
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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