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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.
Register: ClinicalTrials.gov
Last refreshed on: 8 July 2024
Main ID:  NCT04379050
Date of registration: 01/05/2020
Prospective Registration: Yes
Primary sponsor: AbbVie
Public title: 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
Scientific title: 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
Date of first enrolment: June 8, 2020
Target sample size: 130
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/ct2/show/NCT04379050
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
Australia Belgium Canada Denmark Germany Italy Japan Netherlands
Russian Federation Spain Sweden United Kingdom United States
Contacts
Name:     ABBVIE INC.
Address: 
Telephone:
Email:
Affiliation:  AbbVie
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Parkinson's Disease (PD)
Intervention(s)
Drug: ABBV-951
Primary Outcome(s)
Change in Clinical Laboratory Test Data [Time Frame: Up To Week 96]
Change From Baseline in Electrocardiograms (ECGs) [Time Frame: Up To Week 96]
Change in Vital Signs Measurements [Time Frame: Up To Week 96]
Percentage Of Participants With Letter Grade Equal To Or Higher Than D On The Infusion Site Evaluation Scale [Time Frame: Up To Week 96]
Percentage Of Participants With Numeric Grade Equal To Or Higher Than 5 On The Infusion Site Evaluation Scale [Time Frame: Up To Week 96]
Percentage of Participants With Adverse Events (AE) [Time Frame: Up To Week 96]
Secondary Outcome(s)
Change From Baseline in Quality Of Life Measurement as Assessed by PD Questionnaire-39 (PDQ-39) [Time Frame: Up To Week 96]
Cognitive Impairment Measurement [Time Frame: Up To Week 96]
Average Normalized Daily "Off" Time [Time Frame: Up To Week 96]
Average Normalized Daily "On" Time [Time Frame: Up To Week 96]
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]
Parkinson's Disease (PD) Symptoms Measurement [Time Frame: Up To Week 96]
Secondary ID(s)
M15-737
2019-004235-23
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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