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MigrainePhase 2NCT04845178

Investigation of Safety and Efficacy of ABP-450 for Migraine Prevention in Adults

A Phase 2 study testing ABP-450 in people with Migraine, run by AEON Biopharma, Inc. at 62 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. The study will enroll 765 patients across approximately 64 sites in the United States, Canada and Australia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Migraine
What is being tested?
ABP-450
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
797 participants
Where
62 sitesin 3 countries
Study dates
1 Mar 2021to 6 Aug 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient can understand the ICF, provides signed ICF and patient privacy information (eg, Authorization for Use and Release of Health and Research Study Information) before initiating any study-specific procedure, and agrees to comply with protocol requirements.
  • Male or female patients 18 years or older of age (no upper age limit) at the time of signing the informed consent.
  • 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.
  • History of, on average ≥6 migraine or probable migraine days per month in the 3 months prior to Screening.
  • Patient is on a stable dose of medications, if any, as recommended by the patient's health care practitioner, used for acute treatment of migraine for at least 3 months prior to Screening. Patient is not taking any migraine prophylactic treatment prohibited per protocol or if on prophylactic treatment has washed out.
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  • A Woman of Child Bearing Potential (WOCBP) must be willing and able to use a medically acceptable and effective method of birth control as determined by the investigator, during the entire study.
  • A WOCBP must have a negative pregnancy test at Screening.
  • Patient is able to read, understand, and complete the eDiary.
  • Patient is willing and able to adhere to the study assessments, visit schedules, and prohibitions, as described in this protocol.

Who cannot join

  • 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 (eg, cluster headache), or cranial neuropathy.
  • Confounding and clinically significant pain syndromes (eg, fibromyalgia, chronic low back pain, complex regional pain syndromes) as evaluated by the investigator.
  • Diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease that might interfere with the study.
  • Psychiatric conditions that are uncontrolled and/or untreated, including conditions that are not controlled for a minimum of 6 months prior to Screening as evaluated by the investigator. Patients with a lifetime history of psychosis, mania, or dementia are excluded.
Show all 31Show fewer
  • History of addiction, including alcohol or drugs of abuse, within 6 months prior to Screening.
  • Hepatitis B (HBsAg positive) or hepatitis C (ie, detectable HCV RNA) virus infection.
  • Note: Patients with a prior history of treated hepatitis B virus infection who are antigen negative or patients with a prior history of treated HCV infection who are HCV RNA undetectable may be considered after consultation with the study medical monitor.
  • Any infection or clinically significant skin problem in any of the injection sites.
  • Have been injected with anesthesia or steroids in the targeted muscles during the 30 days immediately prior to initiation of the Baseline period.
  • Any medical condition (including but not limited to viral or other active infections) that, in the opinion of the investigator, classifies the patient as unsuitable for participation in the study or patients who do not seem to be in good general health at the time of Screening, and prior to any investigational study drug administration.
  • Note: Patients will not routinely be tested for COVID-19 during the study. Patients presenting with fever or who are symptomatic for COVID-19 will be required to be tested and treated through their general practitioner.
  • Other Diagnostic Assessments
  • Significant risk of self-harm based on clinical interview and responses on the C-SSRS, or of harm to others in the opinion of the investigator; patients must be excluded if they report suicidal ideation with intent, with or without a plan (ie, Type 4 or 5 on the C-SSRS) in the past 6 months or report suicidal behavior in the past 6 months prior to Screening.
  • Body mass index ≥38 kg/m2 at Screening.
  • Prior/Concomitant Medications and Treatments
  • Use of opioids or barbiturates >2 days per month in the 3 months prior to Screening.
  • Use of CBD or other types of cannabinoids in the 3 months prior to Screening and throughout the study.
  • Any use of botulinum toxin for migraine or any other medical reasons within 4 months prior to Screening and during the Screening and Baseline periods and at or above the shoulders at any time during the study.
  • Any monoclonal antibody CGRP inhibitor treatment (within or outside of a clinical study) within 6 months prior to Screening and throughout the study.
  • Any orally administered non-peptide CGRP antagonists (within or outside of a clinical study) within 4 weeks prior to the Baseline period and throughout the study.
  • Use of devices for the treatment of migraine (ie, non-invasive neuromodulation therapies including but not limited to non-invasive nerve stimulation [gammaCore], transcranial magnetic stimulation [Cefaly], external trigeminal nerve stimulation, transcutaneous electrical nerve stimulation, and peripheral neuroelectrical stimulation) during Screening and throughout the study.
  • Any other treatments or therapies (eg, acupuncture in head and neck region, cranial traction, nociceptive trigeminal inhibition, occipital nerve block treatments, and dental splints for headache) to the head, neck, or shoulder regions during Screening and throughout the study that, in the opinion of the investigator, would interfere with the investigational study drug.
  • History of inadequate response to 3 classes of medications (which have different mechanisms of action) prescribed for the prevention of migraine, excluding CGRP therapies.
  • History of hypersensitivity to human serum albumin, sucrose, or botulinum toxin type A or a positive test for botulinum toxin type A antibody.
  • Prior/Concurrent Clinical Study Experience
  • Participation in another interventional study within 6 months prior to Screening and throughout the study.
  • Female patients planning on becoming pregnant during the course of the study and/or lactating/breastfeeding.
  • Patient has donated or lost a significant volume (>450 mL) of blood or plasma within 30 days of screening.
  • Patient is an employee or family member of the investigator, study site personnel, PPD, or AEON.

Trial locations and contacts

62 sites in 3 countries.

62 sites in 3 countries

United States54 sites

  • Albuquerque Clinical Trials Inc

    Albuquerque, New Mexico, 87102

  • Dent Neurologic Institute

    Amherst, New York, 14226

  • NeuroTrials Research Inc. - Clinedge - PPDS

    Atlanta, Georgia, 30328

  • Northwest Clinical Research Center

    Bellevue, Washington, 98004

  • Hassman Research Institute - ClinEdge - PPDS

    Berlin, New Jersey, 08009

  • Boston Clinical Trials Inc

    Boston, Massachusetts, 02131

  • Dayton Center for Neurological Disorders

    Centerville, Ohio, 45459

  • Crescent City Headache and Neurology Center

    Chalmette, Louisiana, 70043

  • MDFirst Research

    Chandler, Arizona, 85226

  • WR-ClinSearch

    Chattanooga, Tennessee, 37421

  • Cedar Crosse Research Center

    Chicago, Illinois, 60607

  • StudyMetrix Research, LLC

    City of Saint Peters, Missouri, 63303

  • Delta Waves LLC - Hunt - PPDS

    Colorado Springs, Colorado, 80918

  • Axiom Research LLC

    Colton, California, 92324

  • DCT - Baxter LLC dba Discovery Clinical Trials

    Dallas, Texas, 75225

  • META Medical Research Institute, LLC

    Dayton, Ohio, 45432

  • Centricity Research Dublin Multispecialty

    Dublin, Ohio, 43016

  • Quest Research Institute - Hunt - PPDS

    Farmington Hills, Michigan, 40825

  • Quality Research of South Florida

    Hialeah, Florida, 33016

  • Henry Ford Allegiance Neurology

    Jackson, Michigan, 49201

  • Velocity Research San Diego

    La Mesa, California, 91942

  • Barrett Clinic, P.C. - Clinedge - PPDS

    La Vista, Nebraska, 68128

  • Sandhill Research, LLC

    Lake Mary, Florida, 32746

  • Canvas Clinical Research

    Lake Worth, Florida, 33467

  • Wake Research - CRCN, LLC

    Las Vegas, Nevada, 89118

  • Collaborative Neuroscience Research

    Long Beach, California, 90806

  • Los Angeles Headache Center

    Los Angeles, California, 90067

  • Drug Studies America, Inc

    Marietta, Georgia, 30060

  • Tandem Clinical Research

    Marrero, Louisiana, 70072

  • Velocity Clinical Research - Boise - ERN - PPDS

    Meridian, Idaho, 83642

  • BioMed Research Institute, INC

    Miami, Florida, 33126

  • Medical Research Center, LLC

    Miami, Florida, 33144

  • Bryant Research Group

    Nashville, Tennessee, 37203

  • The Orthopedic Foundation

    New Albany, Ohio, 43054

  • New York Neurology Associates

    New York, New York, 10003

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Quality Clinical Research

    Omaha, Nebraska, 68114

  • Aspen Clinical Research LLC - Clinedge - PPDS

    Orem, Utah, 84058

  • Kansas Institute of Research, LLC

    Overland Park, Kansas, 66211

  • Innovation Medical Research Center

    Palmetto Bay, Florida, 33157

  • Thomas Jefferson University, Jefferson Headache Center

    Philadelphia, Pennsylvania, 19107

  • Elite Clinical Studies, LLC

    Phoenix, Arizona, 85018

  • Arizona Neuroscience Research

    Phoenix, Arizona, 85032

  • Preferred Primary Care Physicians

    Pittsburgh, Pennsylvania, 15236

  • Anderson Clinical Research

    Redlands, California, 92374

  • Artemis Institute For Clinical Research LLC - San Diego - ClinEdge - PPDS

    San Diego, California, 92103

  • Clinvest Research LLC

    Springfield, Missouri, 65810

  • New England Institute for Neurology and Headache

    Stamford, Connecticut, 06905

  • Mercury Clinical Research Incorporated

    Sugar Land, Texas, 77478

  • Clinical Research Consortium Arizona

    Tempe, Arizona, 85281

  • MedVadis Research

    Waltham, Massachusetts, 02451

  • Paradigm Clinical Research Centers

    Wheat Ridge, Colorado, 80033

  • Upstate Clinical Research Associates LLC

    Williamsville, New York, 14221

  • Clinical Research of Central Florida - ClinEdge - PPDS

    Winter Haven, Florida, 33810

Other trials in United States

Australia4 sites

  • Grampians Health

    Ballarat, Victoria, 3350

  • Emeritus Research

    Camberwell, Victoria, 3124

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Alfred Hospital

    Melbourne, Victoria, 3004

Other trials in Australia

Canada4 sites

  • True North Clinical Research

    Halifax, Nova Scotia, B3S 1N2

  • Diex Recherche Québec

    Québec, Quebec, G1N 4V3

  • CARe Clinic

    Red Deer, Alberta, T4P 1K4

  • Bluewater Clinical Research Group

    Sarnia, Ontario, N7T 4X3

Other trials in Canada

About this study

Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2 Study of ABP-450 (prabotulinumtoxinA) Purified Neurotoxin Complex for the Prevention of Migraine Headache

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. The study will enroll 765 patients across approximately 64 sites in the United States, Canada and Australia. Study subjects will be divided evenly across a low dose group, a high dose group and a placebo group. All patients will receive two treatment cycles of ABP-450 or placebo utilizing the Company's novel injection paradigm.

Read the detailed description

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 per month. The study will enroll 765 patients across approximately 64 sites in the United States, Canada and Australia. Study subjects will be divided evenly across a low dose of ABP-450 group, a high dose of ABP-450 group, and a placebo group. All patients will receive two treatment cycles utilizing the Company's novel treatment paradigm involving fewer injections than the current botulinum toxin treatment option for chronic migraine.

Conditions
Migraine
Being tested
ABP-450, Placebo
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABP-450Drug

    Also called prabotulinumtoxinA

    ABP-450 (prabotulinumtoxinA) contains a 900 kDa botulinum toxin type-A complex produced by the bacterium Clostridium botulinum.

  • PlaceboDrug

    Also called 0.9% sodium chloride, saline

    0.9% sodium chloride, sterile, unpreserved, USP/PhEur

Study groups in NCT04845178
Study groupRoleWhat they receive
ABP-450 - Low DoseExperimentalABP-450 Low Dose - intramuscular injections into specified muscles.
Receives: Drug: ABP-450
ABP-450 - High DoseExperimentalABP-450 High Dose - intramuscular injections into specified muscles.
Receives: Drug: ABP-450
PlaceboPlacebo comparatorPlacebo (0.9% saline, sterile, unpreserved, USP/Ph.Eur) intramuscular injections into specified muscles.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Monthly Migraine Days

    The primary efficacy endpoint will be the change in mean Monthly Migraine Days (MMD) from the 4-week Baseline period to Weeks 21 to 24 Treatment period.

    Measured: Baseline to Weeks 21 to 24 Treatment period.

  2. Incidence of Treatment Emergent Adverse Events

    The primary safety endpoint will be the incidence of TEAEs throughout the study when dosed with placebo, ABP-450 (low dose), or ABP-450 (high dose).

    Measured: Baseline to Week 28 - End of Study.

Secondary outcomes (9)

  1. Percentage of Patients with Reduction in Mean Migraine Days (MMD)

    Percentage of patients with a reduction from Baseline of ≥ 50 percent, ≥ 75 percent and 100% percent in average number of MMD will be assessed by Treatment Group.

    Measured: Baseline to Week 28 - End of Study.

  2. Mean change in Monthly Migraine Days (MMD)

    Overall mean change from Baseline in the number of MMD will be assessed by Treatment Group.

    Measured: Baseline to Week 28 - End of Study.

  3. Mean change in Monthly Migraine Days (MMD) requiring medications for acute treatment of migraine or headaches

    Overall mean change from Baseline in number of MMD requiring migraine specific medication and non-specific medications for the acute treatment of migraine or headache will be assessed by Treatment Group.

    Measured: Baseline to Week 28 - End of Study.

  4. Mean change in Headache Hours

    Overall mean change from Baseline in headache (either moderate or severe) hours will be assessed by Treatment Group.

    Measured: Baseline to Week 28 - End of Study.

  5. Mean Change in Monthly Headache Days

    Overall mean change from Baseline in monthly headache days will be assessed by Treatment Group.

    Measured: Baseline to Week 28 - End of Study.

  6. Mean change of Migraine-Specific-Quality of Life (MSQ) Domains

    The Mean Change in Migraine-Specific-Quality of Life (MSQ), a 14-item assessment, with each item rated on a 6-point scale (ranging from "none of the time" to "all of the time") with higher scores indicating better quality of life will be assessed by Treatment Group.

    Measured: Baseline to Week 28 - End of Study.

  7. Percentage of Patients with Reduction in Migraine Physical Function Impact Diary (MPFID)

    Percentage of patients with a reduction from Baseline in the impact on Migraine Physical Function Impact Diary (MPFID) will be assessed by Treatment Group.

    Measured: Baseline to Week 28 - End of Study.

  8. Suicidality by Columbia-Suicide Severity Rating Scale (C-SSRS)

    Percentage of patients with Suicidal Ideation and Behaviors will be assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS).

    Measured: Baseline to Week 28 - End of Study.

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

    Percentage of patients developing Anti-Drug Antibodies to ABP-450 antibodies (binding and if positive, neutralizing) will be assessed.

    Measured: Baseline to Week 28 - End of Study.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2021
  2. Study start1 Mar 2021
  3. Primary completion19 Jun 2024
  4. Study completion6 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Approximately 765 patients will be randomized in a 1:1:1 ratio and receive 1 of the following 3 treatments: ABP-450 Low Dose, ABP-450 High Dose, or placebo via intramuscular injection into pre-specified areas of the head and neck.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
797 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04845178
Sponsor's protocol ID
ABP-20001
Status last verified
Aug 2024
First submitted
28 Mar 2021
Last updated
4 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Individual Participant Data collected during the trial, after deidentification may be shared following review of the clinical study report by the FDA review division and if a decision is made to publish the results in an publication outside posting the results in clinicaltrials.gov

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABP-450 in people with Migraine, run by AEON Biopharma, Inc. at 62 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in United States, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Monthly Migraine Days (time frame: Baseline to Weeks 21 to 24 Treatment period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04845178.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.

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