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Levodopa/Carbidopa Infusion

ABBV-951 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
Participants who have Parkinson's Disease and who have successfully completed the parent study M15-741
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 96
Awards & highlights

Study Summary

This trial is studying an investigational drug to see if it is safe and effective in treating people with Parkinson's disease.

Who is the study for?
This trial is for adults with advanced Parkinson's Disease who have already completed the parent study M15-741. They should be willing and able to follow the study procedures, including regular clinic visits and remote assessments.Check my eligibility
What is being tested?
The trial continues testing ABBV-951, an unapproved drug delivered as a continuous subcutaneous infusion over 24 hours daily. It aims to assess its safety, effectiveness, and tolerability in managing Parkinson's symptoms.See study design
What are the potential side effects?
Potential side effects of ABBV-951 may include reactions at the infusion site, gastrointestinal issues like nausea or constipation, sleep disturbances, dizziness or fainting spells due to low blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have Parkinson's Disease and completed the M15-741 study.

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 Electrocardiograms (ECGs)
Change in Clinical Laboratory Test Data
Change in Vital Signs Measurements
+3 more
Secondary outcome measures
Average Normalized Daily "Off" Time
Average Normalized Daily "On" Time
Change From Baseline in Health-related Quality Of Life Measurement as Assessed by EuroQol 5-dimensions questionnaire (EQ-5D-5L)
+3 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 solution by continuous subcutaneous infusion (CSCI), at the discretion of the investigator, for up to 96 weeks.
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
954 Previous Clinical Trials
500,914 Total Patients Enrolled
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
101,427 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
145,748 Total Patients Enrolled

Media Library

ABBV-951 (Levodopa/Carbidopa Infusion) Clinical Trial Eligibility Overview. Trial Name: NCT04379050 — Phase 3
Parkinson's Disease Research Study Groups: ABBV-951
Parkinson's Disease Clinical Trial 2023: ABBV-951 Highlights & Side Effects. Trial Name: NCT04379050 — Phase 3
ABBV-951 (Levodopa/Carbidopa Infusion) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04379050 — Phase 3

Frequently Asked Questions

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

What is the precedent for ABBV-951 in terms of medical research?

"Out of the 161 international research sites, 3 are actively conducting clinical trials for ABBV-951. Of these 3, 2 are in Phase 3. While some of the ABBV-951 trials are based in Boca Raton, Florida, others are happening in various other locations."

Answered by AI

What is the primary goal of this research?

"The primary outcome of this study, which will be evaluated over a Up To Week 96 time frame is to Percentage of Participants With Adverse Events (AE). Secondary outcomes include Cognitive Impairment Measurement which is defined as Cognitive impairment is assessed by the Mini-Mental State Examination (MMSE). MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 0 to 30, with higher scores indicating better function"

Answered by AI

Is ABBV-951 a danger to patients?

"There is some evidence of ABBV-951's efficacy, as well as numerous clinical trials demonstrating its safety. Consequently, we have given it a score of 3."

Answered by AI

What is the trial's enrollment limit?

"Unfortunately, this particular study is no longer seeking participants. Though, it is worth noting that there are presently 507 studies actively recruiting patients with parkinson's disease (pd) and 3 studies for ABBV-951 actively recruiting participants."

Answered by AI

Has research like this been conducted before?

"AbbVie's ABBV-951 has had 3 trials across 91 cities and 13 countries since 2020, with the most recent one being a Phase 3 that completed in 2020."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Other
California
Washington
How old are they?
65+
What site did they apply to?
Banner Sun Health Res Inst /ID# 215579
Dartmouth-Hitchcock Medical Center /ID# 216834
Legacy Research Institute /ID# 215536
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's Disease
2020. "Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04379050.
~28 spots leftby Jun 2025
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