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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, day 2, week 1, week 2, week 3, week 4, week 6, week 13, week 26, week 39, and week 52
Awards & highlights

Study Summary

This study is evaluating whether a drug called ABBV-951 is safe and tolerable in people with Parkinson's disease.

Eligible Conditions
  • Parkinson's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 2, week 1, week 2, week 3, week 4, week 6, week 13, week 26, week 39, and week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 2, week 1, week 2, week 3, week 4, week 6, week 13, week 26, week 39, and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Absolute Platelet Count (Hematology): Change From Baseline to End of Study
Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study
Albumin (Clinical Chemistry): Change From Baseline to End of Study
+47 more
Secondary outcome measures
Average Daily Normalized "Off" Time: Change From Baseline to End of Study
Average Daily Normalized "On" Time With Troublesome Dyskinesia: Change From Baseline to End of Study
Average Daily Normalized "On" Time Without Troublesome Dyskinesia: Change From Baseline to End of Study
+7 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

2Treatment groups
Experimental Treatment
Group I: ABBV-951 Low Dose SubgroupExperimental Treatment1 Intervention
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
Group II: ABBV-951 High Dose SubgroupExperimental Treatment1 Intervention
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Foscarbidopa
Not yet FDA approved

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
502,151 Total Patients Enrolled
AbbVie Inc.Study DirectorAbbVie
264 Previous Clinical Trials
101,313 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,865 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)
2019. "A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03781167.
~41 spots leftby Apr 2025
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