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NCT Number: NCT05094050

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Colorado Hospital /ID# 229974, Aurora, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-951

Drug

Continuous Subcutaneous Infusion (CSCI)

Other names: Foslevodopa/foscarbidopa

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 26, 2021
Registry last updated
Mar 24, 2023

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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