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Botulinum Toxin

ABP-450 for Cervical Dystonia

Phase 2
Waitlist Available
Led By Cynthia Comella
Research Sponsored by AEON Biopharma, Inc.
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 52 weeks
Awards & highlights

Study Summary

This trial will study the safety and efficacy of ABP-450 for the treatment of cervical dystonia in adults. The study will enroll 60 patients across approximately 42 sites in the United States and 29 sites in Europe.

Eligible Conditions
  • Cervical Dystonia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-related Serious Adverse Events
Secondary outcome measures
Mean Change in Clinical Global Impression of Change (CGI-C)
Mean Change in Clinical Global Impression of Severity (CGI-S)
Mean Change in Patient Global Impression of Change (PGI-C)
+6 more

Side effects data

From 2022 Phase 2 trial • 61 Patients • NCT04849988
20%
Dysphagia
13%
COVID-19
13%
Torticollis
7%
Headache
7%
Neck pain
7%
Presyncope
7%
Muscular Weakness
7%
Rash macular
100%
80%
60%
40%
20%
0%
Study treatment Arm
ABP-450 - 350U
Placebo
ABP-450 - 150U
ABP-450 - 250U

Trial Design

1Treatment groups
Experimental Treatment
Group I: ABP-450 - Between Low Dose and High DoseExperimental Treatment1 Intervention
ABP-450 Between Low Dose and High Dose - Intramuscular injections into affected neck muscles with investigator's determined dose within the range of low dose and high dose - 4 injection cycles at 3-month intervals.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABP-450
2021
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

AEON Biopharma, Inc.Lead Sponsor
3 Previous Clinical Trials
1,524 Total Patients Enrolled
1 Trials studying Cervical Dystonia
61 Patients Enrolled for Cervical Dystonia
PPDIndustry Sponsor
159 Previous Clinical Trials
36,863 Total Patients Enrolled
1 Trials studying Cervical Dystonia
61 Patients Enrolled for Cervical Dystonia
Cynthia ComellaPrincipal InvestigatorRush University Medical Center

Frequently Asked Questions

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

To what extent is this clinical trial accessible in various locations?

"NeuroStudies.net in Decatur, Central Texas Neurology Consultants PA in Round Rock, and Baylor College of Medicine in Houston are three centres amongst the 24 actively participating locations for this study."

Answered by AI

How many people are currently enlisted in this clinical research?

"This experimental trial is no longer taking on participants. It was initially announced on the 27th of July 2021 and finalized on the 2nd of November 2022. There are currently 30 other studies actively enrolling patients with cervical dystonia and 61 trials for ABP-450 in search of volunteers."

Answered by AI

Do I fulfill the criteria to be included in this clinical experiment?

"To be eligible for this medical trial, patients must be diagnosed with cervical dystonia and aged between 18 to 75 years old. As of now, 52 participants are needed for the study."

Answered by AI

What are the primary clinical applications of ABP-450?

"ABP-450 has demonstrated efficacy in treating urinary incontinence, spinal cord injuries, and botox injections."

Answered by AI

Has ABP-450 been tested in any prior medical experiments?

"At the moment, 61 clinical studies are investigating ABP-450 with 20 of those being in Phase 3. While most trials for this therapy happen at one site located in Farmington Hills, Michigan, there are 754 trial centres throughout the country hosting research related to this medication."

Answered by AI

Could you elucidate the potential risks of ABP-450 on humans?

"ABP-450 is deemed to be moderately safe, garnering a rating of 2 on the safety scale. This tentative assessment is due to it being in the Phase 2 stage, meaning there are some data indicating its security yet none verifying how effective this medication may be."

Answered by AI

Is the age threshold for this study restricted to those over 60 years of age?

"This clinical trial has a stringent age requirement of 18-75 years. If you are either below the legal minimum or above 65, there are additional 9 and 85 trials, respectively, that could be suitable for your needs."

Answered by AI

Are any openings available for participation in the trial at this time?

"This clinical trial is not currently recruiting. Although it was first posted on July 27th 2021, the last update occurred on November 2nd 2022. For those seeking alternative studies related to cervical dystonia, 30 trials are enrolling patients and 61 for ABP-450 recruitment."

Answered by AI

Who else is applying?

What state do they live in?
New York
Texas
How old are they?
18 - 65
What site did they apply to?
Central Texas Neurology Consultants PA
New England Institute for Neurology and Headache
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Extension Study of ABP-19000 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 in Cervical Dystonia
2021. "Extension Study of ABP-19000 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 in Cervical Dystonia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04871451.
~14 spots leftby Apr 2025
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