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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

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%
INFUSION SITE BRUISING
1%
ON AND OFF PHENOMENON
1%
INFUSION SITE HAEMORRHAGE
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
983 Previous Clinical Trials
509,243 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
414 Previous Clinical Trials
151,774 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
~39 spots leftby Apr 2026
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