ABP-450 for Migraine Prevention

Recruiting at 6 trial locations

Overseen By Joseph Lillo

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AEON Biopharma, Inc.

Must not be taking: Opioids, Barbiturates, Cannabinoids, others

Disqualifiers: Chronic tension-type headache, Neuromuscular disease, Uncontrolled psychiatric conditions, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

797 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing ABP-450, a new injection treatment, to see if it can help prevent migraines in adults who have frequent migraines. The study includes 765 patients who will receive either a low dose or high dose. The goal is to find out if ABP-450 can reduce the number of migraine days.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain migraine prevention medications before joining. If you're on a stable dose of medications for acute migraine treatment, you can continue those, but you must not be on any prohibited migraine prevention treatments or must have stopped them before the trial.

What data supports the effectiveness of the drug ABP-450 for migraine prevention?

The research mentions the use of onabotulinum toxin-A, which is similar to ABP-450, showing effectiveness in preventing high-frequency migraines. This suggests that ABP-450 might also be effective for migraine prevention. ^{1 2 3 4 5}

What safety data exists for ABP-450 or similar treatments for migraine prevention?

ABP-450, also known as onabotulinumtoxin A, has been studied for safety in treating chronic migraine. Research shows it causes more treatment-related side effects than a placebo but fewer than some oral medications, indicating it is generally safe for use. ^{2 6 7 8 9}

How does the drug ABP-450 differ from other migraine prevention drugs?

ABP-450 is unique because it is a form of botulinum toxin, which is also used for chronic migraine prevention, unlike many other drugs that are primarily antiepileptics, beta-blockers, or antidepressants. This makes it different in terms of its mechanism of action, as it works by blocking nerve signals that cause muscle contractions, potentially reducing migraine frequency. ^{5 10 11 12 13}

Research Team

Richard B Lipton, MD

Principal Investigator

Albert Einstein College of Medicine

Stewart J Tepper, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

Adults who've had migraines for over a year, with 6+ migraine days monthly. They must be on stable acute treatment doses and not taking prohibited preventatives. Women of childbearing potential need a negative pregnancy test and agree to use birth control. Exclusions include uncontrolled psychiatric conditions, certain infections, recent injections in target muscles, high BMI (≥38), specific medication histories, hypersensitivities, other study participation within 6 months, pregnant or breastfeeding women.

Inclusion Criteria

I've been on a stable dose of acute migraine treatment for 3+ months and am not on any prohibited migraine prevention medication.

If you are a woman who could become pregnant, you need to use a reliable form of birth control throughout the study.

Patient is able to read, understand, and complete the eDiary.

Exclusion Criteria

I do not have any major pain conditions that could confuse my treatment results.

I have been diagnosed with a specific muscle or nerve disease.

You have an active hepatitis B or C virus infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two treatment cycles of ABP-450 or placebo for migraine prevention

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ABP-450

Trial Overview The trial is testing ABP-450's ability to prevent migraines compared to a placebo. Participants will receive two cycles of either low/high dose ABP-450 or placebo through the company's novel injection method. The trial aims to enroll 765 patients across three groups at various international sites.

Participant Groups

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

ABP-450 Low Dose - intramuscular injections into specified muscles.

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

ABP-450 High Dose - intramuscular injections into specified muscles.

Group III: Placebo Placebo Group 1 Intervention

Placebo (0.9% saline, sterile, unpreserved, USP/Ph.Eur) intramuscular injections into specified 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

Findings from Research

In a trial with 32 participants suffering from high-frequency episodic migraines, onabotulinum toxin-A treatment led to a significant reduction of 3.68 migraine days per month, which is a 33.1% decrease from baseline.

The treatment also improved patients' quality of life and reduced the need for acute medication, with 39% of participants experiencing at least a 50% reduction in monthly migraine days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BoNT-A efficacy in high frequency migraine: an open label, single arm, exploratory study applying the PREEMPT paradigm. Martinelli, D., Arceri, S., De Icco, R., et al.[2022]

In a 52-week trial involving 744 adults with migraine, daily oral atogepant 60 mg was found to be safe and well-tolerated, with 67% of participants experiencing treatment-emergent adverse events, mostly mild to moderate.

Atogepant significantly reduced the mean monthly migraine days, with 84.2% of participants achieving at least a 50% reduction in migraine frequency by the end of the study, demonstrating its efficacy as a preventive treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Once-daily oral atogepant for the long-term preventive treatment of migraine: Findings from a multicenter, randomized, open-label, phase 3 trial. Ashina, M., Tepper, SJ., Reuter, U., et al.[2023]

A review of 73 migraine drug trials published between 2010 and 2015 found that while a majority reported adverse events, only 41% included this information in their abstracts, highlighting a gap in transparency.

The study emphasizes the need for all randomized controlled trials on migraine treatments to consistently report adverse events in their abstracts to better assess the safety and tolerability of these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the reporting of adverse events in controlled clinical trials conducted in 2010-2015 on migraine drug treatments. Tfelt-Hansen, P., Lindqvist, JK., Do, TP.[2019]

Onabotulinumtoxin A is an effective treatment for chronic migraine, approved since 2010, and works by targeting the release of neurotransmitters and neuropeptides involved in headache mechanisms.

While onabotulinumtoxin A is associated with more treatment-related adverse events than a placebo, it has fewer side effects compared to the oral medication topiramate, indicating a relatively favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Onabotulinumtoxin A in Chronic Migraine: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Corasaniti, MT., Bagetta, G., Nicotera, P., et al.[2023]

Topiramate is an effective prophylactic treatment for pediatric patients with migraines, showing a significant reduction in headache frequency of 63% to 100% at doses of 100 mg/d and 65% at 200 mg/d, with 83% to 95% of patients experiencing at least a 50% reduction in migraine rate.

The medication is generally well tolerated, although some dose-related side effects like paresthesias, weight loss, and cognitive issues were noted, making the 100 mg/d dose the most favorable in terms of benefit-to-risk ratio.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topiramate for migraine prophylaxis in pediatric patients. Deaton, TL., Mauro, LS.[2018]

Preventive therapy for migraines is recommended for adults experiencing more than 6 headache days per month, with options including FDA-approved medications like propranolol, topiramate, and onabotulinumtoxinA, as well as effective off-label drugs such as lisinopril and amitriptyline.

The response to preventive treatments varies widely among individuals, with complete cessation of headaches being rare, but some patients experience significant relief, highlighting the importance of personalized treatment plans and gradual dose adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacologic Prevention of Migraine: A Narrative Review of the State of the Art in 2018. Loder, E., Rizzoli, P.[2019]

Migraine prophylaxis involves various drug classes, including antidepressants, beta-blockers, and antiepileptics, which work by normalizing neuronal excitability and blocking pain pathways, thus reducing the frequency and intensity of migraine attacks.

Recent trials have shown promising results for new treatments like angiotensin converting enzyme inhibitors and angiotensin II receptor blockers, expanding the options available for migraine prevention beyond traditional medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathophysiological basis of migraine prophylaxis. Galletti, F., Cupini, LM., Corbelli, I., et al.[2009]

References

1. England pubmed.ncbi.nlm.nih.gov

Initial clinical experience with the use of subcutaneous GR43175 in treating acute migraine. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

STOP 301: A Phase 3, open-label study of safety, tolerability, and exploratory efficacy of INP104, Precision Olfactory Delivery (POD® ) of dihydroergotamine mesylate, over 24/52 weeks in acute treatment of migraine attacks in adult patients. [2022]

3. England pubmed.ncbi.nlm.nih.gov

BoNT-A efficacy in high frequency migraine: an open label, single arm, exploratory study applying the PREEMPT paradigm. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

MAP0004, orally inhaled DHE: a randomized, controlled study in the acute treatment of migraine. [2013]

5. England pubmed.ncbi.nlm.nih.gov

New therapeutic approaches for the prevention and treatment of migraine. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Once-daily oral atogepant for the long-term preventive treatment of migraine: Findings from a multicenter, randomized, open-label, phase 3 trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Evaluating the reporting of adverse events in controlled clinical trials conducted in 2010-2015 on migraine drug treatments. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Safety of Onabotulinumtoxin A in Chronic Migraine: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Topiramate for migraine prophylaxis in pediatric patients. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Pharmacologic Prevention of Migraine: A Narrative Review of the State of the Art in 2018. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Pathophysiological basis of migraine prophylaxis. [2009]

12. England pubmed.ncbi.nlm.nih.gov

CGRP monoclonal antibodies in migraine: an efficacy and tolerability comparison with standard prophylactic drugs. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Management of migraine: an algorithmic approach. [2010]