What is the mechanism of action of this treatment?

Levodopa, a precursor to dopamine, is converted to dopamine in the brain, addressing the dopamine deficiency in Parkinson's Disease (PD). Carbidopa inhibits dopa decarboxylase, preventing the premature conversion of levodopa to dopamine outside the brain, thus increasing its availability in the central nervous system. Continuous subcutaneous infusion, such as with ABBV-951, provides a steady delivery of these medications, aiming to reduce motor fluctuations and improve symptom control. This steady delivery is important for PD patients as it helps maintain more consistent symptom management, potentially enhancing their quality of life.

What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease, such as levodopa and carbidopa, including continuous subcutaneous infusion methods like ABBV-951, are associated with several side effects. These include nausea, orthostatic hypotension (a drop in blood pressure upon standing), confusion, hallucinations, and motor fluctuations such as 'wearing off' phenomena where the medication's effect diminishes before the next dose. Additionally, long-term use can lead to dyskinesia, which involves involuntary movements. Continuous infusion methods may also cause localized skin reactions at the infusion site.

What prior FDA approvals exist?

The FDA has approved several treatments for Parkinson's Disease, including oral formulations of carbidopa-levodopa, such as the extended-release IPX066, which aims to reduce motor fluctuations. Continuous subcutaneous infusion therapies, like the one being studied in ABBV-951, are less common but have shown promise in managing advanced Parkinson's Disease symptoms. Another similar treatment is the subcutaneous continuous apomorphine infusion, which has been used to control motor fluctuations in complicated cases. These treatments aim to provide continuous dopaminergic stimulation, which can help reduce motor complications compared to short-acting formulations.

What other types of research exist?

Promising alternatives to ABBV-951 for managing Parkinson's Disease symptoms include: 1) Extended-release carbidopa-levodopa (IPX066), which offers improved motor fluctuation control. 2) Continuous duodenal infusion of levodopa/carbidopa, which has shown marked improvement in quality of life and reduction in dyskinesia severity. 3) Cholinesterase inhibitors like rivastigmine and donepezil, which may provide cognitive and neuropsychiatric benefits in Parkinson's Disease Dementia (PDD).

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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

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new drug called ABBV-951 for adults with advanced Parkinson's disease. The drug is given in a way to help control symptoms. Participants will be monitored through periodic check-ins to ensure the drug's safety and effectiveness.

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.

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.

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 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 Electrocardiograms (ECGs)

Change in Clinical Laboratory Test Data

Change in Vital Signs Measurements

+3 more

Secondary study objectives

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

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 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

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Levodopa, a precursor to dopamine, is converted to dopamine in the brain, addressing the dopamine deficiency in Parkinson's Disease (PD). Carbidopa inhibits dopa decarboxylase, preventing the premature conversion of levodopa to dopamine outside the brain, thus increasing its availability in the central nervous system. Continuous subcutaneous infusion, such as with ABBV-951, provides a steady delivery of these medications, aiming to reduce motor fluctuations and improve symptom control. This steady delivery is important for PD patients as it helps maintain more consistent symptom management, potentially enhancing their quality of life.

Continuous Subcutaneous Levodopa Delivery for Parkinson's Disease: A Randomized Study.Levodopa/carbidopa microtablets in Parkinson's disease: a study of pharmacokinetics and blinded motor assessment.Does levodopa slow or hasten the rate of progression of Parkinson's disease?