NCT05094050

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

January 18, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2023

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

1.2 years

First QC Date

October 20, 2021

Last Update Submit

March 22, 2023

Conditions

Parkinson's Disease

Keywords

Parkinson's DiseaseFoslevodopa/foscarbidopaABBV-951Levodopa (LD)Carbidopa (CD)

Outcome Measures

Primary Outcomes (10)

  • Maximum Observed Plasma Concentration (Cmax) of Levodopa (LD)

    Maximum observed plasma concentration (Cmax) of Levodopa (LD).

    Up to 8 Days

  • 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

  • Minimum Observed Plasma Concentration (Cmin) of LD

    Minimum observed plasma concentration (Cmin) of LD.

    Up to 8 Days

  • Degree of Fluctuation (DFL) of LD

    DFL = (Cmax-Cmin)/(average plasma concentration).

    Up to 8 Days

  • Swing of LD

    Swing = (Cmax-Cmin)/Cmin.

    Up to 8 Days

  • Maximum Observed Plasma Concentration (Cmax) of Carbidopa (CD)

    Maximum observed plasma concentration (Cmax) of CD.

    Up to 8 Days

  • 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

  • Minimum Observed Plasma Concentration (Cmin) of CD

    Minimum observed plasma concentration (Cmin) of CD.

    Up to 8 Days

  • Degree of Fluctuation (DFL) of CD

    DFL = (Cmax-Cmin)/(average plasma concentration).

    Up to 8 Days

  • Swing of CD

    Swing = (Cmax-Cmin)/Cmin.

    Up to 8 Days

Study Arms (4)

Arm 1: ABBV-951

EXPERIMENTAL

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

Arm 2: ABBV-951

EXPERIMENTAL

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

Arm 3: ABBV-951

EXPERIMENTAL

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

Arm 4: ABBV-951

EXPERIMENTAL

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

Interventions

ABBV-951DRUG

Continuous Subcutaneous Infusion (CSCI)

Also known as: Foslevodopa/foscarbidopa
Arm 1: ABBV-951Arm 2: ABBV-951Arm 3: ABBV-951Arm 4: ABBV-951

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University of Colorado Hospital /ID# 229974

Aurora, Colorado, 80045, United States

Location

Georgetown University Hospital /ID# 230224

Washington D.C., District of Columbia, 20007, United States

Location

Rush University Medical Center /ID# 229983

Chicago, Illinois, 60612, United States

Location

Carolina Phase 1, LLC /ID# 239836

Raleigh, North Carolina, 27612-8106, United States

Location

The Movement Disorder Clinic of Oklahoma /ID# 238610

Tulsa, Oklahoma, 74136-6378, United States

Location

Vanderbilt University Medical Center /ID# 230255

Nashville, Tennessee, 37232-0011, United States

Location

Parkinson Disease Movement Disorders Clinic /ID# 245791

Austin, Texas, 78746, United States

Location

Texas Movement Disorder Specialists /ID# 238607

Georgetown, Texas, 78628-4126, United States

Location

Baylor College of Medicine - Baylor Medical Center /ID# 239631

Houston, Texas, 77030-3411, United States

Location

University of Utah Health Care /ID# 241219

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2021

First Posted

October 26, 2021

Study Start

January 18, 2022

Primary Completion

March 17, 2023

Study Completion

March 17, 2023

Last Updated

March 24, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(10)