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Botulinum Toxin
A Phase 2 Study to Evaluate the Safety and Efficacy of ABP-450 in the Treatment of Cervical Dystonia
Little Rock, AR
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 20 weeks
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 moreSide effects data
From 2022 Phase 2 trial • 61 Patients • NCT0484998820%
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
Closest Location:University of Arkansas for Medical Sciences· Little Rock, AR
Who is running the clinical trial?
PPD DEVELOPMENT, LPIndustry Sponsor
163 Previous Clinical Trials
37,254 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
Joseph JankovicPrincipal InvestigatorBaylor St. Luke's Medical Center
1 Previous Clinical Trials
51 Total Patients Enrolled
1 Trials studying Torticollis
51 Patients Enrolled for Torticollis
Cynthia Comella, MDPrincipal InvestigatorRush University Medical Center