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

NCT ID: NCT05094050

Last Updated: 2023-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-18

Study Completion Date

2023-03-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

ABBV-951

Intervention Type DRUG

Continuous Subcutaneous Infusion (CSCI)

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).

Group Type EXPERIMENTAL

ABBV-951

Intervention Type DRUG

Continuous Subcutaneous Infusion (CSCI)

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).

Group Type EXPERIMENTAL

ABBV-951

Intervention Type DRUG

Continuous Subcutaneous Infusion (CSCI)

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).

Group Type EXPERIMENTAL

ABBV-951

Intervention Type DRUG

Continuous Subcutaneous Infusion (CSCI)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ABBV-951

Continuous Subcutaneous Infusion (CSCI)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Foslevodopa/foscarbidopa

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Colorado Hospital /ID# 229974

Aurora, Colorado, United States

Site Status

Georgetown University Hospital /ID# 230224

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

Site Status

Rush University Medical Center /ID# 229983

Chicago, Illinois, United States

Site Status

Carolina Phase 1, LLC /ID# 239836

Raleigh, North Carolina, United States

Site Status

The Movement Disorder Clinic of Oklahoma /ID# 238610

Tulsa, Oklahoma, United States

Site Status

Vanderbilt University Medical Center /ID# 230255

Nashville, Tennessee, United States

Site Status

Parkinson Disease Movement Disorders Clinic /ID# 245791

Austin, Texas, United States

Site Status

Texas Movement Disorder Specialists /ID# 238607

Georgetown, Texas, United States

Site Status

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

Houston, Texas, United States

Site Status

University of Utah Health Care /ID# 241219

Salt Lake City, Utah, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

M20-339

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Infusion of Apomorphine: Long-term Safety Study
NCT02339064 ACTIVE_NOT_RECRUITING PHASE3