Study to Assess How ABBV-951 is Absorbed When Administered at Different Subcutaneous Sites of Adult Participants With Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Parkinson's Disease: A Comparative Study of Levodopa and Carbidopa Bioavailability Following Foslevodopa/Foscarbidopa Infusion at Different Subcutaneous Sites in Parkinson's Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05094050
• Other study ID #: M20-339
• Status: Completed
• Phase: Phase 1
• Start date: January 18, 2022
• Est. completion date: March 17, 2023

Study information

• Verified date: March 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Parkinson's disease (PD) is a neurological condition, which means it affects the brain. This study will evaluate how ABBV-951 is absorbed under the skin of participants with PD when administered to arm, thigh and flank compared to the abdomen. ABBV-951 is an investigational drug being developed for the treatment of PD. Study doctors randomly assign participants to 1 of 4 groups, called treatment arms. Each treatment arm receives ABBV-951 administered in a different order in the arm, high, flank and abdomen. Approximately 12 adult participants over 30 years with a diagnosis of PD will be enrolled in approximately 10 sites in the United States. Participants will receive continuous (24hours/day) subcutaneous infusion of ABBV-951 for 2 consecutive days for each infusion site (arm, thigh, flank and abdomen), for a total duration of treatment up to 12 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will be confined at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Adverse events will be monitored throughout the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 17, 2023
• Est. primary completion date: March 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of idiopathic Parkinson's disease (PD) that is Levodopa-responsive.
• Must be taking a minimum of 400 mg/day of levodopa equivalents (LE) and be judged by the investigator to have motor symptoms inadequately controlled by current therapy.
• Must have recognizable/identifiable "Off" and "On" states (motor fluctuations), and have a minimum daily average of 2.5 hours of "Off" time (with a minimum of 2 hours of "Off" time each day).

Exclusion Criteria:

• History of significant skin conditions or disorders (e.g., psoriasis, atopic dermatitis, etc.) or evidence of recent sunburn, acne, scar tissue, tattoo, open wound, branding, or colorations that in the investigator's opinion would interfere with the infusion of the study drug or could interfere with study assessments.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• ABBV-951
Continuous Subcutaneous Infusion (CSCI)

Locations

Country	Name	City	State
United States	University of Colorado Hospital /ID# 229974	Aurora	Colorado
United States	Parkinson Disease Movement Disorders Clinic /ID# 245791	Austin	Texas
United States	Rush University Medical Center /ID# 229983	Chicago	Illinois
United States	Texas Movement Disorder Specialists /ID# 238607	Georgetown	Texas
United States	Baylor College of Medicine - Baylor Medical Center /ID# 239631	Houston	Texas
United States	Vanderbilt University Medical Center /ID# 230255	Nashville	Tennessee
United States	Carolina Phase 1, LLC /ID# 239836	Raleigh	North Carolina
United States	University of Utah Health Care /ID# 241219	Salt Lake City	Utah
United States	The Movement Disorder Clinic of Oklahoma /ID# 238610	Tulsa	Oklahoma
United States	Georgetown University Hospital /ID# 230224	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of Levodopa (LD)	Maximum observed plasma concentration (Cmax) of Levodopa (LD).	Up to 8 Days
Primary	Area Under the Plasma Concentration-Time Curve (AUC) for the 24-hour Interval of LD	Area under the plasma concentration-time curve (AUC) for the 24-hour interval of LD.	Up to 8 Days
Primary	Minimum Observed Plasma Concentration (Cmin) of LD	Minimum observed plasma concentration (Cmin) of LD.	Up to 8 Days
Primary	Degree of Fluctuation (DFL) of LD	DFL = (Cmax-Cmin)/(average plasma concentration).	Up to 8 Days
Primary	Swing of LD	Swing = (Cmax-Cmin)/Cmin.	Up to 8 Days
Primary	Maximum Observed Plasma Concentration (Cmax) of Carbidopa (CD)	Maximum observed plasma concentration (Cmax) of CD.	Up to 8 Days
Primary	Area Under the Plasma Concentration-Time Curve (AUC) for the 24-hour Interval of CD	Area under the plasma concentration-time curve (AUC) for the 24-hour interval of CD.	Up to 8 Days
Primary	Minimum Observed Plasma Concentration (Cmin) of CD	Minimum observed plasma concentration (Cmin) of CD.	Up to 8 Days
Primary	Degree of Fluctuation (DFL) of CD	DFL = (Cmax-Cmin)/(average plasma concentration).	Up to 8 Days
Primary	Swing of CD	Swing = (Cmax-Cmin)/Cmin.	Up to 8 Days