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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
Patient has at least a 1-year history of episodic migraine (with or without aura) or chronic migraine (with or without aura) according to the ICHD-3 (2018) definition and diagnostic criteria.
Age of the patient at the time of migraine onset <50 years.
Must not have
History of migraine accompanied by specific symptoms
Current diagnosis of specific headache disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to weeks 21 to 24 treatment period.
Summary
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.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While the side effects are not detailed here, common ones for migraine prevention treatments can include reactions at the injection site such as pain or swelling, muscle weakness near where the medicine was injected, flu-like symptoms and allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had migraines for at least a year, with or without aura.
Select...
My migraines started before I turned 50.
Select...
I've had 6 or more migraine days monthly in the last 3 months.
Select...
I have had migraines for at least a year, as defined by the ICHD-3.
Select...
My migraines started before I turned 50.
Select...
I've had 6 or more migraine days monthly in the last 3 months.
Select...
I have had migraines for at least a year, with or without aura.
Select...
My migraines started before I turned 50.
Select...
I have had 6 or more migraine days each month for the last 3 months.
Select...
I am 18 or older with a history of migraines for at least a year.
Select...
My migraines started before I turned 50.
Select...
I have had 6 or more migraine days monthly in the last 3 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of migraines with specific symptoms.
Select...
I have been diagnosed with a specific type of headache disorder.
Select...
I do not have any major pain conditions that could confuse my treatment results.
Select...
I have been diagnosed with a specific muscle or nerve disease.
Select...
I have no infections or major skin issues where injections are given.
Select...
I've tried 3 different types of migraine prevention medications without success, not including CGRP therapies.
Select...
I am not planning to become pregnant or breastfeed during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to weeks 21 to 24 treatment period.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to weeks 21 to 24 treatment period.
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
+6 moreOther 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
+1 moreSide effects data
From 2022 Phase 2 trial • 61 Patients • NCT0484998820%
Dysphagia
13%
Torticollis
13%
COVID-19
7%
Neck pain
7%
Muscular Weakness
7%
Headache
7%
Presyncope
7%
Rash macular
100%
80%
60%
40%
20%
0%
Study treatment Arm
ABP-450 - 350U
Placebo
ABP-450 - 150U
ABP-450 - 250U
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
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.
Group III: PlaceboPlacebo Group1 Intervention
Placebo (0.9% saline, sterile, unpreserved, USP/Ph.Eur) 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
Find a Location
Who is running the clinical trial?
PPD DEVELOPMENT, LPIndustry Sponsor
158 Previous Clinical Trials
35,252 Total Patients Enrolled
2 Trials studying Migraine
520 Patients Enrolled for Migraine
PPDIndustry Sponsor
161 Previous Clinical Trials
35,594 Total Patients Enrolled
2 Trials studying Migraine
520 Patients Enrolled for Migraine
AEON Biopharma, Inc.Lead Sponsor
3 Previous Clinical Trials
578 Total Patients Enrolled
1 Trials studying Migraine
466 Patients Enrolled for Migraine
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.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.You have a high risk of hurting yourself or someone else.I have not taken certain medications or undergone specific treatments recently.You have had strong allergic reactions to certain things in the past.I am not planning to become pregnant or breastfeed during the study.My migraines started before I turned 50.I have had 6 or more migraine days monthly in the last 3 months.I have been on a stable migraine medication dose for 3 months.Women of childbearing potential must have a negative pregnancy test before starting the study.I have not had injections with anesthesia or steroids in my muscles in the last 30 days.I have no infections or major skin issues where injections are given.Your body mass index is 38 or higher.If you are a woman of childbearing potential, you must have a negative pregnancy test before being included in the study.I've tried 3 different types of migraine prevention medications without success, not including CGRP therapies.I am 18 or older with a history of migraines for at least a year.I have had migraines for at least a year, with or without aura.I have a history of migraines with specific symptoms.I have been diagnosed with a specific type of headache disorder.You had problems with addiction in the 6 months before the screening.I am 18 years old or older.My migraines started before I turned 50.You are willing and able to comply with the study assessments, visit schedules, and prohibitions, as described in this protocol.I have had migraines for at least a year, with or without aura.I've had 6 or more migraine days monthly in the last 3 months.I've had 6 or more migraine days monthly in the last 3 months.My migraines started before I turned 50.My migraines started before I turned 50.I have had 6 or more migraine days each month for the last 3 months.I am 18 years or older.I have had migraines for at least a year, as defined by the ICHD-3.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: ABP-450 - Low Dose
- Group 3: ABP-450 - High Dose
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Migraine Patient Testimony for trial: Trial Name: NCT04845178 — Phase 2
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