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Botulinum Toxin

ABP-450 for Torticollis

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

Summary

This trial will test ABP-450 to see if it can help adults with cervical dystonia by calming overactive nerves that cause neck muscle contractions. ABP-450 is a form of botulinum toxin type A, which has been used in various formulations to treat cervical dystonia by reducing muscle contractions.

Eligible Conditions
  • Torticollis

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Treatment-Related Serious Adverse Events
Secondary study objectives
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%
Torticollis
13%
COVID-19
7%
Neck pain
7%
Muscular Weakness
7%
Headache
7%
Presyncope
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
~910

Find a Location

Who is running the clinical trial?

PPD DEVELOPMENT, LPIndustry Sponsor
158 Previous Clinical Trials
35,988 Total Patients Enrolled
AEON Biopharma, Inc.Lead Sponsor
3 Previous Clinical Trials
1,314 Total Patients Enrolled
1 Trials studying Torticollis
51 Patients Enrolled for Torticollis
PPDIndustry Sponsor
161 Previous Clinical Trials
36,330 Total Patients Enrolled
1 Trials studying Torticollis
51 Patients Enrolled for Torticollis
~13 spots leftby Nov 2025
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