Purpose

The purpose of this study is to assess the safety and tolerability of ABBV-951 in subjects with Parkinson's disease (PD).

Condition

Eligibility

Eligible Ages
Over 30 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Subjects with diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa -responsive
  • Subjects must be judged by the investigator to be inadequately controlled by current therapy, have recognizable/identifiable "Off" and "On" states (motor fluctuations), and have a minimum of 2.5 hours of "Off" time per day

Exclusion Criteria

  • Subject is cognitively impaired and is not able to safely and effectively manage the drug delivery system and the diaries and is not able to adhere to the study.
  • Subject is considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason.

Study Design

Phase
Phase 3
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ABBV-951
Participants will receive ABBV-951 by continuous subcutaneous infusion (CSCI) for 52 weeks.
  • Drug: ABBV-951
    solution for infusion
    Other names:
    • Foscarbidopa
    • Foslevodopa

Recruiting Locations

University of Alabama at Birmingham - Main /ID# 207996
Birmingham, Alabama 35233

More Details

NCT ID
NCT03781167
Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
847.283.8955
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.