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NCT04750226 · ClinicalTrials.gov registry record · Phase 3

Study To Assess Adverse Events and Change in Disease Activity Of 24-hour Continuous Subcutaneous Infusion Of ABBV-951 In Adult Participants With Advanced Parkinson's Disease

A Phase 3 study of Parkinsons Disease (PD), sponsored by AbbVie.

Active
Registry status
Phase 3
Development phase
118
Enrollment target
20
Study locations

NCT04750226 is a Phase 3 study of Parkinsons Disease (PD) that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 118 participants, roughly in line with the 113-participant average among 19 other Parkinsons Disease (PD) trials with a reported enrollment target. The trial reports 20 study locations across 6 states.

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The verdict

NCT04750226, a Phase 3 study of Parkinsons Disease (PD), is active but no longer recruiting, sponsored by AbbVie.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
118 participants
Enrollment target
20
Study locations

Study Summary

Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study will assess how safe and effective ABBV-951 is in adult participants with PD. Adverse events and change in disease activity is evaluated. ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP) given as an infusion under the skin for the treatment of Parkinson's Disease. Adult participants with advanced PD and who have completed M15-736 or M20-339 study will be enrolled. Approximately 130 participants will be enrolled in the study in approximately 60 sites in the United States and Australia. Participants will receive continuous subcutaneous infusion (CSCI) (under the skin) of ABBV-951 for 96 weeks during the Primary Treatment Period and during the optional Extended Treatment Period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical and remote telephone assessments, blood tests, checking for side effects, and completing questionnaires.

Conditions Studied

Parkinsons Disease (PD)

Interventions

  • DRUG ABBV-951

Study Locations (20)

California

  • Neuro Pain Medical Center /ID# 217720 - Fresno
  • Loma Linda University Medical /ID# 217724 - Loma Linda
  • University of California, Los Angeles /ID# 218460 - Los Angeles
  • SC3 Research Group - Pasadena /ID# 223018 - Pasadena
  • University of California, San /ID# 218595 - San Diego
  • Duplicate_Cedars-Sinai Medical Center-West Hollywood /ID# 218607 - West Hollywood

Colorado

  • University of Colorado Hospital /ID# 218486 - Aurora
  • Alpine Clinical Research Center /ID# 218461 - Boulder
  • Denver Neurological Research, LLC /ID# 217811 - Denver
  • CenExel Rocky Mountain Clinical Research, LLC /ID# 217731 - Englewood

Florida

  • Visionary Investigators Network - Miami /ID# 217726 - Miami
  • Renstar Medical Research /ID# 217837 - Ocala
  • Neurology Associates Ormond Beach /ID# 217800 - Ormond Beach
  • Parkinson's Disease Treatment Center of Southwest Florida /ID# 222679 - Port Charlotte

Arizona

  • Xenoscience, Inc /ID# 222515 - Phoenix
  • Muhammad Ali Parkinson Center /ID# 218609 - Phoenix
  • Movement Disorders Center of Arizona /ID# 218471 - Scottsdale

Alabama

  • University of Alabama at Birmingham - Main /ID# 217814 - Birmingham
  • University of South Alabama /ID# 218467 - Mobile

District of Columbia

  • Georgetown University Hospital /ID# 218599 - Washington D.C.

Trial Details

FieldValue
Enrollment Target 118 participants
Start Date 2021-02-18
Est. Completion 2026-04
Phase Phase 3

Sponsor

AbbVie

526 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04750226

The ClinicalTrials.gov registry entry for NCT04750226 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 113-participant average among 19 other Parkinsons Disease (PD) trials with a reported enrollment target. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Parkinsons Disease (PD) appearing as the primary indexed condition, and to 1 intervention - of which ABBV-951 is the first listed.

NCT04750226 reports 20 study locations spanning 6 distinct geographic areas - top geographies include California, Colorado, Florida.

Frequently Asked Questions

What is clinical trial NCT04750226 about?

NCT04750226 is a clinical study titled "Study To Assess Adverse Events and Change in Disease Activity Of 24-hour Continuous Subcutaneous Infusion Of ABBV-951 In Adult Participants With Advanced Parkinson's Disease". Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study will assess how safe and effective ABBV-951 is in...

What is the current status of trial NCT04750226?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 118 participants. The study started on 2021-02-18. Estimated completion is 2026-04.

What conditions does trial NCT04750226 study?

This clinical trial studies the following conditions: Parkinsons Disease (PD).

What interventions are being tested in trial NCT04750226?

The interventions under investigation include: ABBV-951 (DRUG).

Who is sponsoring clinical trial NCT04750226?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04750226 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.