ABBV-951
Drugpowder for solution
NCT Number: NCT03374917
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of 4 weeks of continuous infusion with ABBV-951 in adult subjects with Parkinson's Disease (PD).
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Notify Me30 year–85 year
All sexes
Interventional
Phase 1
Banner Sun Health Res Inst /ID# 165840, Sun City, Arizona, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
powder for solution
Time frame: 28 Days
Local tolerability (infusion site evaluation) was assessed using the Infusion Site Assessment 2-part rating scale.
Time frame: From first dose of study drug to 30 days after last dose of study drug (up to 2 months)
Treatment emergent adverse events defined as any adverse event from the time of study drug administration until 30 days after discontinuation of study drug.
Time frame: 28 days
Vital signs will be collected both supine and standing.
Time frame: 28 days
The C-SSRS is an instrument designed to assess suicidal behavior and ideation.
Time frame: 28 days
Blood samples for serum chemistry tests will be collected following a minimum 8-hour fast.
Time frame: 28 days
A 12-lead ECG will be performed after the participant has been supine for at least 5 minutes.
Time frame: Days 1, 7, 14, 21, and 28
Blood samples for pharmacokinetic assessment will be collected twice at each visit.
AbbVie
Industry
An Open-Label Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 for up to 4 Weeks in an Outpatient Environment
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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