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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 52 - end of study
Awards & highlights

Study Summary

This trial will study if ABP-450 could help prevent migraines in adults who get six or more migraine days per month. The study will have 690 patients from the US, Canada, and Australia.

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.Check my eligibility
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.See study design
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.

Timeline

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

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
+3 more
Other 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
+3 more

Side effects data

From 2022 Phase 2 trial • 61 Patients • NCT04849988
20%
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

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
~120

Find a Location

Who is running the clinical trial?

AEON Biopharma, Inc.Lead Sponsor
3 Previous Clinical Trials
910 Total Patients Enrolled
1 Trials studying Migraine
797 Patients Enrolled for Migraine
PPDIndustry Sponsor
159 Previous Clinical Trials
36,249 Total Patients Enrolled
2 Trials studying Migraine
851 Patients Enrolled for Migraine
Richard B Lipton, MDPrincipal InvestigatorAlbert Einstein College of Medicine
2 Previous Clinical Trials
998 Total Patients Enrolled
1 Trials studying Migraine
797 Patients Enrolled for Migraine

Media Library

ABP-450 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05016661 — Phase 2
Migraine Research Study Groups: ABP-450 - Low Dose, ABP-450 - High Dose
Migraine Clinical Trial 2023: ABP-450 Highlights & Side Effects. Trial Name: NCT05016661 — Phase 2
ABP-450 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05016661 — Phase 2
Migraine Patient Testimony for trial: Trial Name: NCT05016661 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the target enrollment for this specific clinical trial?

"Recruitment for this clinical trial has concluded. The initiation date was October 19th 2021 and the last update occurred on November 17th 2022. If you are searching for alternative studies, there are currently 172 trials that accept patients with migraine and 61 research projects where ABP-450 is being tested which are still accepting participants."

Answered by AI

What potential risks does ABP-450 pose to those using it?

"There is some safety data available for ABP-450, so our team at Power assigned it a score of 2. This drug has yet to pass phase 3 trials, indicating the lack of efficacy results."

Answered by AI

What conditions are typically treated with ABP-450?

"ABP-450 is the leading treatment for urinary incontinence and can also prove beneficial in addressing spinal cord issues, botox injections, as well as overactive bladder syndrome."

Answered by AI

What objectives does this experiment intend to realize?

"This experiment, conducted over a 48-week period from baseline to the end of treatment, will primarily measure the incidence of adverse events. Secondary outcomes include evaluating anti-drug antibodies for ABP-450 and assessing changes in monthly migraine days requiring medications as well as headache hours across treatment groups."

Answered by AI

Are there a number of health centers conducting this research trial in the city?

"To participate in this medical trial, prospective participants can find a recruiting centre such as Diex Recherche Québec in Quebec, META Medical Research Institute LLC located in Dayton or the New England Institute for Neurology and Headache situated in Stamford. Additionally, there are 48 other sites accepting enrolments now."

Answered by AI

To what extent has ABP-450 been investigated in other research studies?

"Currently, there are 61 active clinical investigations into ABP-450 with 20 of them at the final Phase 3 stage. For the sake of convenience, most enrolment for these studies is occurring in Farmington Hills, Michigan; however, ABP-450 trials are taking place across 754 other sites around the world."

Answered by AI

Is the enrollment phase of this research still open?

"The clinicaltrials.gov database reveals that this particular medical trial, which was first published on October 19th 2021, is not currently taking in new participants. However, 233 other studies are recruiting patients at the time of writing."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
California
North Carolina
Other
How old are they?
18 - 65
What site did they apply to?
Artemis Institute For Clinical Research LLC - San Diego - ClinEdge - PPDS
Drug Studies America, Inc
Infinity Clinical Research LLC
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

For releif and for the money for the trial. I have multiple migraines throughout the month that tend to make me physically sick on a weekly sometimes daily basis.
PatientReceived 1 prior treatment

How responsive is this trial?

Most responsive sites:
  1. Los Angeles Headache Center: < 24 hours
Typically responds via
Phone Call
Average response time
  • < 1 Day
~201 spots leftby Jun 2025