A Phase 2 Study to Evaluate the Safety and Efficacy of ABP-450 in the Treatment of Cervical Dystonia

Recruiting at 24 trial locations

Overseen By Del Stagg, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AEON Biopharma, Inc.

Must be taking: Anticholinergics, Benzodiazepines

Must not be taking: Rimabotulinumtoxin B

Disqualifiers: Traumatic torticollis, Myasthenia gravis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

61 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stay on a stable dose of any medications you are using for focal dystonia treatment, like anticholinergics and benzodiazepines, for at least 3 months before and throughout the study.

What is the purpose of this trial?

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.

Research Team

Joseph Jankovic

Principal Investigator

Baylor St. Luke's Medical Center

Cynthia Comella, MD

Principal Investigator

Rush University Medical Center

Eligibility Criteria

Inclusion Criteria

TWSTRS total score ≥20

TWSTRS pain score ≥1

You have a TWSTRS score of 10 or higher.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intramuscular injections of ABP-450 or placebo for one treatment cycle

4 weeks

Weekly visits for injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Treatment Details

Interventions

• ABP-450
• Placebo

Participant Groups

Group I: ABP-450 - Medium Dose Experimental Treatment 1 Intervention

ABP-450 Mid Dose - Intramuscular injections into affected neck muscles.

Group II: ABP-450 - Low Dose Experimental Treatment 1 Intervention

ABP-450 Low Dose - Intramuscular injections into affected neck muscles.

Group III: ABP-450 - High Dose Experimental Treatment 1 Intervention

ABP-450 High Dose - Intramuscular injections into affected neck muscles.

Group IV: Placebo Placebo Group 1 Intervention

Placebo (0.9% saline, sterile, unpreserved, USP/Ph.Eur.) - Intramuscular injections into affected neck muscles.

Who Is Running the Clinical Trial?

AEON Biopharma, Inc.

Lead Sponsor

Trials

4

Recruited

1,400+

PPD DEVELOPMENT, LP

Industry Sponsor

Trials

167

Recruited

38,000+

David Simmons

PPD DEVELOPMENT, LP

Chief Executive Officer since 2012

BSc in Applied Science from Georgia Institute of Technology

Martina Flammer

PPD DEVELOPMENT, LP

Chief Medical Officer since 2024

MD

PPD Development, LP

Industry Sponsor

PPD

Industry Sponsor

Trials

162

Recruited

36,600+

Dr. Austin Smith

PPD

Chief Medical Officer since 2020

Doctor of Medicine from the Royal College of Surgeons in Ireland

David Simmons

PPD

Chief Executive Officer since 2012

Bachelor’s degree in Applied Mathematics and Industrial Management from Carnegie Mellon University