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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to weeks 21 to 24 treatment period.
Awards & highlights
Study Summary
This trial will test a new drug, ABP-450, to see if it can prevent migraines in adults who have them frequently (6+ days/month). 690 patients will be enrolled at 60 sites in the US, Canada, and Australia, and will be given either the drug (in low or high doses) or a placebo.
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.Check my eligibility
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.See study design
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.
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My migraines started before I turned 50.
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I've had 6 or more migraine days monthly in the last 3 months.
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I have had migraines for at least a year, as defined by the ICHD-3.
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My migraines started before I turned 50.
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I've had 6 or more migraine days monthly in the last 3 months.
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I have had migraines for at least a year, with or without aura.
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My migraines started before I turned 50.
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I have had 6 or more migraine days each month for the last 3 months.
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I am 18 or older with a history of migraines for at least a year.
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My migraines started before I turned 50.
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I have had 6 or more migraine days monthly in the last 3 months.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Monthly Migraine Days
Incidence of Treatment Emergent Adverse Events
Secondary outcome measures
Development of Anti-Drug Antibodies (ADA) to ABP-450
Mean Change in Monthly Headache Days
Mean change in Headache Hours
+6 moreOther outcome measures
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%
COVID-19
13%
Torticollis
7%
Headache
7%
Presyncope
7%
Neck pain
7%
Muscular Weakness
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
~120
Find a Location
Who is running the clinical trial?
PPDIndustry Sponsor
159 Previous Clinical Trials
36,118 Total Patients Enrolled
2 Trials studying Migraine
720 Patients Enrolled for Migraine
AEON Biopharma, Inc.Lead Sponsor
3 Previous Clinical Trials
779 Total Patients Enrolled
1 Trials studying Migraine
666 Patients Enrolled for Migraine
Richard B Lipton, MDPrincipal InvestigatorAlbert Einstein College of Medicine
2 Previous Clinical Trials
867 Total Patients Enrolled
1 Trials studying Migraine
666 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has ABP-450 earned clearance from the Federal Drug Administration?
"Due to the lack of evidence for ABP-450's efficacy, our assessment gave it a score of 2 on a scale from 1 to 3. Nonetheless, there is sufficient data attesting to its safety."
Answered by AI
Can you provide information on other experiments involving ABP-450?
"At present, 156 clinical trials are exploring the potential of ABP-450 with 42 at Phase 3. Although Calgary in Alberta is densely populated with such studies, there are 1052 other research sites across the globe working on treatments using ABP-450."
Answered by AI
Are individuals still able to enroll in this research trial?
"Based on the information hosted by clinicaltrials.gov, this study is actively enrolling patients. It was initially posted in March of 2021 and last updated November 22nd 2022."
Answered by AI
What ailments does ABP-450 typically alleviate?
"ABP-450 can be administered to patients with elevated intra ocular pressure (iop), nasal irritation, or glabellar lines."
Answered by AI
How many facilities are contributing data to this research endeavor?
"This medical study is currently enrolling from 71 different sites, including New Albany, Marrero and Dallas. To cut down on travel expenses, it's advised to select the nearest available clinical trial site when signing up."
Answered by AI
How many participants are being included in this trial?
"Affirmative. According to the information accessible on clinicaltrials.gov, this medical study is presently recruiting participants after being first posted in March 2021 and most recently updated in November 2022. 765 individuals need to be enrolled from 71 different health centres."
Answered by AI
What key aims are being pursued through this research endeavor?
"This medical trial, which will last 28 weeks in total and begin with a baseline assessment, is designed to measure the alteration of migraine days. Secondary outcomes include mean change in monthly migraine days, mean change in monthly headache days, and the development of anti-drug antibodies (ADA) towards ABP-450."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
New York Neurology Associates
Aspen Clinical Research LLC - Clinedge - PPDS
Thomas Jefferson University, Jefferson Headache Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
Arizona
Pennsylvania
Florida
Other
How many prior treatments have patients received?
1
2
0
3+
Why did patients apply to this trial?
I need the help. I’m interested in trying something that could be more effective for my headaches.
PatientReceived no prior treatments
Well because I suffer with migraines among other things and I want and need some help!
PatientReceived no prior treatments
I've tried 2 different medication and nothing has helped I am hoping trial would help me.
PatientReceived no prior treatments
Tried a handful of different drugs and holistic methods to no avail of any sort of relief.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long so screaming takes? How long is the research study? What kind of compensation is provided, if at all?
PatientReceived no prior treatments
Are there incentives? Monetary or discounted medications long term? Also what does the trial process look like?
PatientReceived 1 prior treatment
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Email
Phone Call
Most responsive sites:
- New York Neurology Associates: < 24 hours
- Thomas Jefferson University, Jefferson Headache Center: < 24 hours
- Albuquerque Clinical Trials Inc - Clinedge - PPDS: < 48 hours
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