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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

No Placebo-Only Group

Pivotal Trial

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 96

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

FALL

DYSKINESIA

ON AND OFF PHENOMENON

GASTROOESOPHAGEAL REFLUX DISEASE

CHEST PAIN

ACUTE HEPATITIS B

HYPOPHAGIA

PARKINSONISM HYPERPYREXIA SYNDROME

INFUSION SITE BRUISING

INFUSION SITE HAEMORRHAGE

DIAPHRAGM MUSCLE WEAKNESS

CONSTIPATION

PARKINSONISM

BALANCE DISORDER

100%

80%

60%

40%

20%

Study treatment Arm

LD/CD Stabilization Period

LD/CD + Placebo for ABBV-951

ABBV-951 + Placebo for LD/CD

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

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