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ABBV-951 for Parkinson's Disease

Phase 1
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 8 days
Awards & highlights

Study Summary

This trial will study how ABBV-951 is absorbed under the skin of participants with PD when administered to arm, thigh and flank compared to the abdomen.

Eligible Conditions
  • Parkinson's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Plasma Concentration-Time Curve (AUC) for the 24-hour Interval of CD
Area Under the Plasma Concentration-Time Curve (AUC) for the 24-hour Interval of LD
Degree of Fluctuation (DFL) of CD
+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

4Treatment groups
Experimental Treatment
Group I: Arm 4: ABBV-951Experimental Treatment1 Intervention
Participants will receive ABBV-951 for 2 consecutive days in the flank (Period 1), thigh (Period 2), abdomen (Period 3) and arm (Period 4).
Group II: Arm 3: ABBV-951Experimental Treatment1 Intervention
Participants will receive ABBV-951 for 2 consecutive days in the thigh (Period 1), arm (Period 2), flank (Period 3) and abdomen (Period 4).
Group III: Arm 2: ABBV-951Experimental Treatment1 Intervention
Participants will receive ABBV-951 for 2 consecutive days in the arm (Period 1), abdomen (Period 2), thigh (Period 3) and flank (Period 4).
Group IV: Arm 1: ABBV-951Experimental Treatment1 Intervention
Participants will receive ABBV-951 for 2 consecutive days in the abdomen (Period 1), flank (Period 2), arm (Period 3) and thigh (Period 4).
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
958 Previous Clinical Trials
502,368 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
147,082 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment figure for this clinical trial?

"AbbVie requires a total of 12 participants to adhere to the clinical trial's inclusion criteria and have chosen two sites, Northwell Health Physician Partners Neuroscience Institute at Great Neck (ID# 240509) in New york and University of Colorado Hospital (ID# 229974) in Aurora, Colorado."

Answered by AI

What other research endeavors have been attempted with ABBV-951?

"As of the present, there are 3 ongoing clinical trials researching ABBV-951 with 2 trials in Phase 3. In Boca Raton, Florida alone there is a plethora of sites running these experiments; however, when looking across all 161 locations offering this study, it becomes evident how much effort is being put into understanding its effects."

Answered by AI

Are there any remaining vacancies for participants in this clinical experiment?

"According to clinicaltrials.gov, this trial is currently enlisting patients since it was first posted on January 18th 2022 and most recently updated October 3rd 2022."

Answered by AI

How many sites have been selected to conduct this experiment?

"This clinical trial is currently enlisting patients from 14 distinct sites. Examples of such centres include Northwell Health Physician Partners Neuroscience Institute /ID# 240509 in Great Neck, University of Colorado Hospital/ ID# 229974 in Aurora and St. David's Healthcare Partnership L.P., LLP /ID# 245791 in Chicago as well as 11 other medical locations."

Answered by AI

Has ABBV-951 been given regulatory authorization by the FDA?

"Although limited data is available to support ABBV-951's efficacy and safety, our team has assigned it a score of 1 on the risk scale."

Answered by AI

Is this an innovative clinical trial with no prior precedent?

"ABBV-951 has been in development since 2020 and was initially trialled by pharmaceutical giant AbbVie. After receiving Phase 3 drug approval following its initial 130 patient trial, there are now three active studies for the medication spanning 91 cities and 13 countries worldwide."

Answered by AI

Who else is applying?

What state do they live in?
Texas
North Carolina
How old are they?
65+
What site did they apply to?
University of Utah Health Care /ID# 241219
Parkinson Disease Movement Disorders Clinic /ID# 245791
Carolina Phase 1, LLC /ID# 239836
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
2

What questions have other patients asked about this trial?

.Does the drug have a track record for helping with freezing of gate? WIll there be any placebos in this trial?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

Interested in research studies that may provide better treatment as/if my condition worsens.
PatientReceived no prior treatments
I am currently taking Carbo-levodopa. 300 mg every 3 To 4 hours daily. Still having major movement issues,.
PatientReceived no prior treatments
~5 spots leftby Apr 2025