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Levodopa/Carbidopa Infusion

ABBV-951 Infusion for Parkinson's Disease

Phase 3
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 96
Awards & highlights

Study Summary

This trial will assess the safety and effectiveness of ABBV-951, given as a continuous subcutaneous infusion, in adult participants with advanced Parkinson's disease.

Who is the study for?
This trial is for adults with advanced Parkinson's Disease who have already completed the M15-736 or M20-339 study. It's not open to those whom the investigator deems unsuitable for receiving ABBV-951.Check my eligibility
What is being tested?
The trial tests ABBV-951, an unapproved drug delivered as a continuous subcutaneous infusion over 96 weeks, potentially followed by an extended period. The focus is on safety and effectiveness in reducing Parkinson's symptoms.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, typical PD medication side effects like nausea or dizziness, and any other unexpected adverse events related to long-term continuous use.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 96
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 96 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Cognitive Impairment as Assessed by the Mini-Mental State Examination (MMSE)
Change From Baseline in Electrocardiograms (ECGs)
Change From Baseline in Impulsive-Compulsive Disorders and related behaviors as assessed in Parkinson's Disease- Rating Scale (QUIP-RS)
+7 more
Secondary outcome measures
Change From Baseline in Average Daily Normalized "Off" Time as Assessed by the PD Diary
Change From Baseline in Average Normalized "On" Time as Assessed by the Parkinson's Disease (PD) Diary
Change From Baseline in Health-related Quality of Life as Assessed by EQ-5D-5L
+8 more

Side effects data

From 2021 Phase 3 trial • 174 Patients • NCT04380142
3%
FALL
3%
DYSKINESIA
1%
CONSTIPATION
1%
ON AND OFF PHENOMENON
1%
INFUSION SITE HAEMORRHAGE
1%
INFUSION SITE BRUISING
1%
DIAPHRAGM MUSCLE WEAKNESS
1%
PARKINSONISM
1%
PARKINSONISM HYPERPYREXIA SYNDROME
1%
HYPOPHAGIA
1%
GASTROOESOPHAGEAL REFLUX DISEASE
1%
CHEST PAIN
1%
ACUTE HEPATITIS B
1%
BALANCE DISORDER
100%
80%
60%
40%
20%
0%
Study treatment Arm
LD/CD Stabilization Period
LD/CD + Placebo for ABBV-951
ABBV-951 + Placebo for LD/CD

Trial Design

1Treatment groups
Experimental Treatment
Group I: ABBV-951Experimental Treatment1 Intervention
Participants will receive ABBV-951 by continuous subcutaneous infusion (CSCI) for 96 weeks during the Primary Treatment Period and during the optional Extended Treatment Period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABBV-951
2019
Completed Phase 3
~490

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
502,266 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,980 Total Patients Enrolled

Media Library

ABBV-951 (Levodopa/Carbidopa Infusion) Clinical Trial Eligibility Overview. Trial Name: NCT04750226 — Phase 3
Parkinson's Disease Research Study Groups: ABBV-951
Parkinson's Disease Clinical Trial 2023: ABBV-951 Highlights & Side Effects. Trial Name: NCT04750226 — Phase 3
ABBV-951 (Levodopa/Carbidopa Infusion) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04750226 — Phase 3
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT04750226 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are participating in this clinical trial?

"This study is not searching for new patients at the moment. The listing was first put up on February 18th, 2021 and updated October 17th, 2022. If you are interested in others studies, 517 trials concerning Parkinson's disease (PD) are actively recruiting patients while 19 more are specifically looking for individuals to participate in testing ABBV-951."

Answered by AI

What are some of the more popular indications for ABBV-951?

"While manganese intoxication is often treated with ABBV-951, this drug is also effective in managing advanced motor fluctuations, restless legs syndrome (rls), and carbon monoxide intoxication."

Answered by AI

Are there other instances where ABBV-951 has been put to the test in a scientific setting?

"ABBV-951 was first studied in 2014 at Tel Aviv Sourasky Medical Center. As of now, there a total of 180 completed trials. Currently, 19 clinical trials are actively recruiting patients, many of which are based out of Englewood, Colorado."

Answered by AI

In how many hospitals is this trial being conducted?

"Patients can be seen and accepted at CenExel Rocky Mountain Clinical Research, LLC /ID# 217731 in Englewood, Colorado, Legacy Medical Group - Neurology /ID# 217804 in Portland, Oregon, and Georgetown University Hospital /ID# 218599 in Washington D.C., among the other 66 locations participating in this clinical trial."

Answered by AI

What are the reported side effects of ABBV-951?

"There is some clinical evidence to support ABBV-951's efficacy, as well as data from multiple rounds of safety trials. Therefore, it received a score of 3 on our Power scale."

Answered by AI

Are patient applications currently being accepted for this clinical trial?

"This study has completed recruitment and is no longer looking for participants. The trial was first posted on February 18th, 2021 and updated October 17th, 2022. If you are seeking other studies, 517 trials concerning parkinson's disease (pd) are recruiting patients while 19 studies regarding ABBV-951 are actively enrolling patients."

Answered by AI

What are the researchers aiming to discover with this trial?

"The purpose of this 96-week study is to compare the effects of two different dosages of medication on vital signs and quality of life in PD patients. Additionally, investigators will track changes in morning routines and symptom severity over the course of the trial using established rating scales."

Answered by AI

Who else is applying?

What state do they live in?
Washington
California
Texas
Other
How old are they?
65+
18 - 65
What site did they apply to?
Muhammad Ali Parkinson Center /ID# 218609
The Parkinson's & Movement Disorder Institute - Fountain Valley /ID# 217806
Loma Linda University Medical /ID# 217724
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

To help further modern medicine. I am in the beginning stages and have been prescribed Carbidopa-Levodopa by my doctor. I want to do anything possible to stop the progression of this disease.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
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
2021. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04750226.
~28 spots leftby May 2025
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