ABP-450 for Wryneck
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.12345
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.678910
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intramuscular injections of ABP-450 or placebo for one treatment cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ABP-450
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
AEON Biopharma, Inc.
Lead Sponsor
PPD DEVELOPMENT, LP
Industry Sponsor
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
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