What side effects are associated with this type of intervention?

Botulinum toxin type A, used for migraine prevention, can cause side effects such as neck pain, muscle weakness, and injection site pain. Other common treatments for migraines, like triptans, may lead to dizziness, fatigue, and chest tightness. Preventive medications such as beta-blockers and antiepileptics can cause fatigue, weight gain, and cognitive disturbances. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

OnabotulinumtoxinA (Botox) is an FDA-approved treatment for chronic migraine, which involves administering intramuscular injections every three months. This treatment has shown efficacy in reducing the number of headache days in adults with chronic migraine. Other formulations of botulinum toxin, such as abobotulinumtoxinA, have also been studied for similar uses, although FDA approval for migraine treatment is specifically for onabotulinumtoxinA.

What other types of research exist?

Promising novel alternatives to ABP-450 for migraine treatment in 2024 include CGRP (calcitonin gene-related peptide) inhibitors such as Erenumab, Fremanezumab, and Galcanezumab, which have shown efficacy in preventing migraines. Additionally, non-pharmacological options like neuromodulation devices (e.g., Cefaly, gammaCore) are gaining traction for their ability to reduce migraine frequency and severity with minimal side effects.

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Monoclonal Antibodies

ABP-450 for Migraine Prevention

Phase 2

Waitlist Available

Led By Richard B Lipton, MD

Research Sponsored by AEON Biopharma, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Medical conditions: History of migraine accompanied by diplopia or decreased level of consciousness, or retinal migraine, current diagnosis of chronic tension-type headache, new persistent daily headache, trigeminal autonomic cephalgia, or cranial neuropathy, confounding and clinically significant pain syndromes, diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease, psychiatric conditions that are uncontrolled and/or untreated, lifetime history of psychosis, mania, or dementia, history of addiction, any infection or clinically significant skin problem in any of the injection sites

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 52 - end of study

Awards & highlights

No Placebo-Only Group

Summary

This trial tests ABP-450, a new injection treatment, to prevent migraines in adults. The goal is to see if these injections can reduce the frequency of migraines.

Who is the study for?

Adults who've had six or more migraine days per month and completed the ABP-20001 study can join. They must be in good health, not pregnant, willing to use birth control, and able to follow the study plan including using an eDiary. People with certain psychiatric conditions, chronic pain syndromes, neuromuscular diseases, or a history of substance abuse are excluded.

What is being tested?

The trial is testing two doses of ABP-450 for preventing migraines over four treatment cycles. It's an extension of a previous Phase 2 trial involving about 666 patients across multiple sites in North America and Australia.

What are the potential side effects?

While specific side effects aren't listed here, similar treatments often cause injection site reactions, muscle weakness near the injection area, flu-like symptoms, allergic reactions to ingredients like human serum albumin or botulinum toxin type A.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 52 - end of study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 52 - end of study

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 52 - end of study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Monthly Migraine Days

Incidence of Treatment Emergent Adverse Events

Secondary study objectives

Development of Anti-Drug Antibodies (ADA) to ABP-450

Mean Change in Monthly Headache Days

Mean change in Headache Hours

+3 more

Other study objectives

Mean Change in Migraine Disability Assessment Score (MIDAS) Total Score

Mean Change in Patient Global Impression of Change (PGI-C) Score

Mean Change in Patient Global Impression of Severity (PGI-S) Score

+3 more

Side effects data

From 2022 Phase 2 trial • 61 Patients • NCT04849988

20%

Dysphagia

13%

Torticollis

13%

COVID-19

Neck pain

Muscular Weakness

Headache

Presyncope

Rash macular

100%

80%

60%

40%

20%

Study treatment Arm

ABP-450 - 350U

Placebo

ABP-450 - 150U

ABP-450 - 250U

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: ABP-450 - Low DoseExperimental Treatment1 Intervention

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

Group II: ABP-450 - High DoseExperimental Treatment1 Intervention

ABP-450 High Dose - intramuscular injections into specified muscles

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ABP-450

2021

Completed Phase 2

~910

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Botulinum Toxin, such as ABP-450, works by inhibiting the release of neurotransmitters, reducing muscle contractions, and potentially decreasing the release of pain-related neuropeptides like CGRP. This mechanism is crucial for preventing migraine attacks. Other common treatments include CGRP monoclonal antibodies, which block the activity of CGRP, a key molecule in migraine pathophysiology, and various oral medications targeting different pathways involved in migraine development. Understanding these mechanisms helps in selecting the most effective treatment tailored to the patient's specific migraine biology.

Calcitonin Gene-Related Peptide Monoclonal Antibody Versus Botulinum Toxin for the Preventive Treatment of Chronic Migraine: Evidence From Indirect Treatment Comparison.[Botulinum toxin type A in headache treatment : Established and experimental indications].