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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
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 belowSelect...
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
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 moreSecondary 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 moreSide effects data
From 2021 Phase 3 trial • 174 Patients • NCT043801423%
FALL
3%
DYSKINESIA
1%
ON AND OFF PHENOMENON
1%
GASTROOESOPHAGEAL REFLUX DISEASE
1%
CHEST PAIN
1%
ACUTE HEPATITIS B
1%
HYPOPHAGIA
1%
PARKINSONISM HYPERPYREXIA SYNDROME
1%
INFUSION SITE BRUISING
1%
INFUSION SITE HAEMORRHAGE
1%
DIAPHRAGM MUSCLE WEAKNESS
1%
CONSTIPATION
1%
PARKINSONISM
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
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?
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?
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
1,010 Previous Clinical Trials
518,616 Total Patients Enrolled
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
101,491 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
435 Previous Clinical Trials
159,896 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Parkinson's Disease and completed study M15-741.You are willing and able to comply with the procedures required in the protocol.I have Parkinson's Disease and completed the M15-741 study.
Research Study Groups:
This trial has the following groups:- Group 1: ABBV-951
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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