Summary

Eligibility
for people ages 30 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

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.

Official Title

An Open-Label Extension of Studies M15-736 and M20-339 to Evaluate the Safety and Tolerability of 24-Hour Daily Exposure of ABBV-951 in Subjects With Advanced Parkinson's Disease

Keywords

Parkinson's Disease (PD), Parkinson's Disease, PD, ABBV-951, Levodopa/Carbidopa (LD/CD), Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP), Parkinson Disease

Eligibility

You can join if…

Open to people ages 30 years and up

  • Completion of the parent study, Study M15-736 or Study M20-339.

You CAN'T join if...

  • Participant considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason.

Locations

  • University of California, Los Angeles /ID# 218460
    Los Angeles California 90095 United States
  • Cedars-Sinai Medical Center-West Hollywood /ID# 218607
    West Hollywood California 90048 United States
  • SC3 Research Group - Pasadena /ID# 223018
    Pasadena California 91105-3149 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT04750226
Phase
Phase 3 Parkinson's Disease Research Study
Study Type
Interventional
Participants
About 118 people participating
Last Updated