ABP-450 for Wryneck

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new treatment called ABP-450 for individuals with cervical dystonia, a condition causing painful neck muscle spasms. Participants will receive one of three different doses of ABP-450 or a placebo to evaluate its effectiveness in relieving symptoms. Suitable candidates have a diagnosis of cervical dystonia and have maintained stable medication use for the condition for at least three months. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that ABP-450 is likely to be safe for humans?

Research has shown that ABP-450 is generally safe for people. Studies have found that all three doses of ABP-450 meet safety standards, with participants experiencing only mild side effects. These results remain consistent across different uses of ABP-450, such as preventing migraines. Overall, the treatment appears safe for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cervical dystonia?

Unlike the standard treatments for cervical dystonia, such as botulinum toxin injections like Botox, ABP-450 offers a potentially new formulation of botulinum toxin. Researchers are excited about ABP-450 because it may provide a more tailored dosing strategy with low, medium, and high doses available, potentially leading to better symptom control. Additionally, this treatment could offer improved efficacy or durability, leading to longer-lasting relief from muscle contractions. The excitement is fueled by the hope that ABP-450 might offer patients a more effective or convenient option compared to existing therapies.

What evidence suggests that ABP-450 might be an effective treatment for cervical dystonia?

Research shows that ABP-450 may help treat cervical dystonia, a condition that causes neck muscle spasms. In this trial, participants will receive a low, medium, or high dose of ABP-450, or a placebo. Studies have found that patients who received low and medium doses of ABP-450 showed noticeable improvements in their symptoms after four weeks. This suggests the treatment might reduce muscle spasms and improve neck movement. Although early results for other conditions like migraines were less promising, the findings for cervical dystonia are encouraging. Overall, these results offer hope that ABP-450 could be a helpful treatment for people with this condition. ^{6 7 8 9 10}

Who Is on the Research Team?

Joseph Jankovic

Principal Investigator

Baylor St. Luke's Medical Center

Cynthia Comella, MD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

TWSTRS total score ≥20

TWSTRS pain score ≥1

You have a TWSTRS score of 10 or higher.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• ABP-450
• Placebo

How Is the Trial Designed?

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

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04849988

A Phase 2 Study to Evaluate the Safety and Efficacy of ABP ...

This Phase 2 trial will evaluate the safety and efficacy of ABP-450 for the treatment of cervical dystonia in adults. The study will enroll 60 patients across ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04871451

NCT04871451 | Extension Study of ABP-19000 to Evaluate ...

This Open-label Extension trial will evaluate the safety and efficacy of ABP-450 for the treatment of cervical dystonia in adults. The study will enroll 60 ...

3.

neurologylive.com

neurologylive.com/view/aeon-biopharma-reports-disappointing-interim-phase-2-results-migraine-preventive-abp-450

AEON Biopharma Reports Disappointing Interim Phase 2 ...

On the primary end point, results showed that treatment with ABP-450 resulted in MMD reductions of 4.8 and 5.0 days in the 150 U and 195 U dose ...

4.

biospace.com

biospace.com/aeon-biopharma-reports-positive-topline-results-from-phase-2-clinical-trial-of-abp-450-prabotulinumtoxina-in-cervical-dystonia

AEON Biopharma Reports Positive Topline Results from ...

Subjects treated with the low and mid doses of ABP-450 showed a statistically significant improvement from baseline at week four, compared with ...

5.

neurology.org

neurology.org/doi/10.1212/WNL.0000000000208091

Efficacy and Safety of DaxibotulinumtoxinA for Injection in ...

This study demonstrated that DAXI, at doses of 125U and 250U, is an effective, safe, long-acting, and well-tolerated treatment for CD.

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S0041010124000977

Efficacy and Safety of ABP-450 (PrabotulinumtoxinA) in ...

Conclusions. ABP-450 was generally safe and well tolerated after multiple treatment cycles in the OLE phase of the current study. Treatment with ABP-450, ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04845178

Investigation of Safety and Efficacy of ABP-450 for Migraine ...

This Phase 2 trial will evaluate the efficacy and safety of ABP-450 for migraine prevention in adults who suffer from six or more migraine days per month.

8.

investors.aeonbiopharma.com

investors.aeonbiopharma.com/investors/news/press-release-details/2022/AEON-Biopharma-Reports-Positive-Topline-Results-from-Phase-2-Clinical-Trial-of-ABP-450-prabotulinumtoxinA-in-Cervical-Dystonia/default.aspx

Press Release Details

The study met its primary safety endpoint with all three doses of ABP-450 appearing to be generally safe and well tolerated with adverse event ...

9.

godeepak.com

godeepak.com/wp-content/uploads/2020/12/Deepwhite-ABP-450-Powder-CI-220-SDS-AUG-2020.pdf

Deepwhite ABP 450 Powder - CAS no.: 16470-24-9

Precautionary statement(s). Prevention. No dangerous properties. Response. No dangerous properties. Storage. Store at ambient temperature. Page ...

10.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0041010124000977

Efficacy and Safety of ABP-450 (PrabotulinumtoxinA) in ...

Conclusions. ABP-450 was generally safe and well tolerated after multiple treatment cycles in the OLE phase of the current study. Treatment with ABP-450, ...