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Botulinum Toxin

ABP-450 for Cervical Dystonia

Phase 2
Waitlist Available
Led By Joseph Jankovic
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 baseline up to 20 weeks
Awards & highlights

Study Summary

This study is evaluating whether a drug may help treat cervical dystonia, a condition that causes the neck to twist and turn.

Eligible Conditions
  • Cervical Dystonia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 20 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 20 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
Number of Participants With Treatment-Related Serious Adverse Events
Secondary outcome measures
Mean Change in Clinical Global Impression of Change (CGI-C) From Baseline to Week 4
Mean Change in Patient Global Impression of Change (PGI-C) From Baseline to Week 4
Mean Change in the Subscale Score of Disability of the Baseline Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) From Baseline to Week 4
+3 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

4Treatment groups
Experimental Treatment
Placebo Group
Group I: ABP-450 - Medium DoseExperimental Treatment1 Intervention
ABP-450 Mid Dose - Intramuscular injections into affected neck muscles.
Group II: ABP-450 - Low DoseExperimental Treatment1 Intervention
ABP-450 Low Dose - Intramuscular injections into affected neck muscles.
Group III: ABP-450 - High DoseExperimental Treatment1 Intervention
ABP-450 High Dose - Intramuscular injections into affected neck muscles.
Group IV: PlaceboPlacebo Group1 Intervention
Placebo (0.9% saline, sterile, unpreserved, USP/Ph.Eur.) - Intramuscular injections into affected neck muscles.
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
1,515 Total Patients Enrolled
1 Trials studying Cervical Dystonia
52 Patients Enrolled for Cervical Dystonia
PPDIndustry Sponsor
159 Previous Clinical Trials
36,854 Total Patients Enrolled
1 Trials studying Cervical Dystonia
52 Patients Enrolled for Cervical Dystonia
Joseph JankovicPrincipal InvestigatorBaylor St. Luke's Medical Center
1 Previous Clinical Trials
52 Total Patients Enrolled
1 Trials studying Cervical Dystonia
52 Patients Enrolled for Cervical Dystonia

Frequently Asked Questions

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

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?
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
A Phase 2 Study to Evaluate the Safety and Efficacy of ABP-450 in the Treatment of Cervical Dystonia
2021. "A Phase 2 Study to Evaluate the Safety and Efficacy of ABP-450 in the Treatment of Cervical Dystonia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04849988.
~15 spots leftby Apr 2025
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