ABP-450 for Migraine Prevention

No longer recruiting at 7 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, ABP-450, to determine if it can reduce the number of migraine days experienced each month. Participants will divide into three groups: one receiving a low dose, another a high dose, and a third receiving a placebo (a non-active substance). Researchers aim to assess whether ABP-450 is safe and effective for individuals with at least six migraine days a month. Suitable participants are adults who have experienced migraines for over a year and currently suffer from frequent migraines. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

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

Research has shown that ABP-450, a type of botulinum toxin, is generally safe and well-tolerated. In a previous trial, all doses of ABP-450 proved safe, with no major safety issues reported. Most side effects were mild and manageable. Although ABP-450 did not meet some effectiveness goals for treating chronic migraines, its safety remained acceptable. This suggests that ABP-450 might be a safe option for preventing migraines, but discussing potential risks and benefits with a doctor is always important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for migraine prevention?

Researchers are excited about ABP-450 for migraine prevention because it offers a unique approach compared to existing treatments like triptans and CGRP inhibitors. Unlike these standard options, which primarily focus on alleviating symptoms after a migraine starts, ABP-450 is designed to prevent migraines before they even begin. ABP-450 utilizes a botulinum toxin-based approach, focusing on nerve and muscle interactions to reduce migraine frequency and intensity. This new mechanism of action provides hope for individuals who have not found relief with current preventive medications.

What evidence suggests that ABP-450 might be an effective treatment for migraine prevention?

Research has shown that ABP-450 might reduce the number of migraine days for individuals who frequently experience migraines. In some studies, participants taking 150 or 195 units of ABP-450 experienced about 4.8 to 5.0 fewer migraine days each month. This trial will test various doses of ABP-450, including both low and high doses, to evaluate its effectiveness in reducing migraine frequency. Although these results are promising, some findings were less positive, indicating that further research is necessary to fully understand its benefits. Overall, ABP-450 shows potential for those seeking migraine relief. ^{1 3 5 6 7}

Who Is on the Research Team?

Stewart J Tepper, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Richard B Lipton, MD

Principal Investigator

Albert Einstein College of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

Citations

1. 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.

2. 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 ...

3. withpower.com withpower.com/trial/phase-3-migraine-disorders-2-2021-82d75

ABP-450 for Migraine Prevention · Info for Participants 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 ...

4. biospace.com biospace.com/aeon-biopharma-announces-topline-results-from-phase-2-trial-of-abp-450-prabotulinumtoxina-for-the-preventive-treatment-of-episodic-migraine

AEON Biopharma Announces Topline Results from Phase ... ABP-450 doses of 150 units and 195 units showed treatment effect of 4.8 days and 5.0 days, respectively, in the mean change from baseline in monthly migraine ...

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

6. withpower.com withpower.com/trial/phase-3-migraine-disorders-2-2021-82d75?lat=34.60184&lng=-117.81218

ABP-450 for Migraine Prevention · Info for Participants 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 ...

7. ctv.veeva.com ctv.veeva.com/study/investigation-of-safety-and-efficacy-of-abp-450-for-migraine-prevention-in-adults

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