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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05094050
Recruitment Status : Completed
First Posted : October 26, 2021
Last Update Posted : March 24, 2023
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: ABBV-951 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 18, 2022
Actual Primary Completion Date : March 17, 2023
Actual Study Completion Date : March 17, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1: ABBV-951
Participants will receive ABBV-951 for 2 consecutive days in the abdomen (Period 1), flank (Period 2), arm (Period 3) and thigh (Period 4).
 Drug: ABBV-951
Continuous Subcutaneous Infusion (CSCI)
Other Name: Foslevodopa/foscarbidopa
Experimental: Arm 2: ABBV-951
Participants will receive ABBV-951 for 2 consecutive days in the arm (Period 1), abdomen (Period 2), thigh (Period 3) and flank (Period 4).
 Drug: ABBV-951
Continuous Subcutaneous Infusion (CSCI)
Other Name: Foslevodopa/foscarbidopa
Experimental: Arm 3: ABBV-951
Participants will receive ABBV-951 for 2 consecutive days in the thigh (Period 1), arm (Period 2), flank (Period 3) and abdomen (Period 4).
 Drug: ABBV-951
Continuous Subcutaneous Infusion (CSCI)
Other Name: Foslevodopa/foscarbidopa
Experimental: Arm 4: ABBV-951
Participants will receive ABBV-951 for 2 consecutive days in the flank (Period 1), thigh (Period 2), abdomen (Period 3) and arm (Period 4).
 Drug: ABBV-951
Continuous Subcutaneous Infusion (CSCI)
Other Name: Foslevodopa/foscarbidopa


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) of Levodopa (LD) [ Time Frame: Up to 8 Days ]
    Maximum observed plasma concentration (Cmax) of Levodopa (LD).

  2. Area Under the Plasma Concentration-Time Curve (AUC) for the 24-hour Interval of LD [ Time Frame: Up to 8 Days ]
    Area under the plasma concentration-time curve (AUC) for the 24-hour interval of LD.

  3. Minimum Observed Plasma Concentration (Cmin) of LD [ Time Frame: Up to 8 Days ]
    Minimum observed plasma concentration (Cmin) of LD.

  4. Degree of Fluctuation (DFL) of LD [ Time Frame: Up to 8 Days ]
    DFL = (Cmax-Cmin)/(average plasma concentration).

  5. Swing of LD [ Time Frame: Up to 8 Days ]
    Swing = (Cmax-Cmin)/Cmin.

  6. Maximum Observed Plasma Concentration (Cmax) of Carbidopa (CD) [ Time Frame: Up to 8 Days ]
    Maximum observed plasma concentration (Cmax) of CD.

  7. Area Under the Plasma Concentration-Time Curve (AUC) for the 24-hour Interval of CD [ Time Frame: Up to 8 Days ]
    Area under the plasma concentration-time curve (AUC) for the 24-hour interval of CD.

  8. Minimum Observed Plasma Concentration (Cmin) of CD [ Time Frame: Up to 8 Days ]
    Minimum observed plasma concentration (Cmin) of CD.

  9. Degree of Fluctuation (DFL) of CD [ Time Frame: Up to 8 Days ]
    DFL = (Cmax-Cmin)/(average plasma concentration).

  10. Swing of CD [ Time Frame: Up to 8 Days ]
    Swing = (Cmax-Cmin)/Cmin.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05094050


Locations
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United States, Colorado
University of Colorado Hospital /ID# 229974
Aurora, Colorado, United States, 80045
United States, District of Columbia
Georgetown University Hospital /ID# 230224
Washington, District of Columbia, United States, 20007
United States, Illinois
Rush University Medical Center /ID# 229983
Chicago, Illinois, United States, 60612
United States, North Carolina
Carolina Phase 1, LLC /ID# 239836
Raleigh, North Carolina, United States, 27612-8106
United States, Oklahoma
The Movement Disorder Clinic of Oklahoma /ID# 238610
Tulsa, Oklahoma, United States, 74136-6378
United States, Tennessee
Vanderbilt University Medical Center /ID# 230255
Nashville, Tennessee, United States, 37232-0011
United States, Texas
Parkinson Disease Movement Disorders Clinic /ID# 245791
Austin, Texas, United States, 78746
Texas Movement Disorder Specialists /ID# 238607
Georgetown, Texas, United States, 78628-4126
Baylor College of Medicine - Baylor Medical Center /ID# 239631
Houston, Texas, United States, 77030-3411
United States, Utah
University of Utah Health Care /ID# 241219
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT05094050    
Other Study ID Numbers: M20-339
First Posted: October 26, 2021    Key Record Dates
Last Update Posted: March 24, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Parkinson's Disease
Foslevodopa/foscarbidopa
ABBV-951
Levodopa (LD)
Carbidopa (CD)
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases