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Botulinum Toxin

ABP-450 for Torticollis

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

No Placebo-Only Group

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

Torticollis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 52 weeks

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

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)

Mean Change in Patient Global Impression of Change (PGI-C)

Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score

+3 more

Side effects data

From 2022 Phase 2 trial • 61 Patients • NCT04849988

20%

Dysphagia

13%

Torticollis

13%

COVID-19

Neck pain

Muscular Weakness

Headache

Presyncope

Rash macular

100%

80%

60%

40%

20%

Study treatment Arm

ABP-450 - 350U

Placebo

ABP-450 - 150U

ABP-450 - 250U

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~910

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