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MigrainePhase 2NCT05016661

Extension Study of ABP-20001 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 for Migraine Prevention

A Phase 2 study testing ABP-450 in people with Migraine, run by AEON Biopharma, Inc. at 55 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This Phase 2 Extension 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 approximately 666 patients across approximately 65 sites in the United States, Canada and Australia from the Phase 2 trial. 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?
No, everyone receives an active treatment
How many people
466 participants
Where
55 sitesin 3 countries
Study dates
19 Oct 2021to 30 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.
  • Patient was enrolled in Study ABP-20001 and successfully completed that study's treatment and procedures.
  • A 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 urine pregnancy test at Visit 1.
  • Patient can 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

  • Did not meet eligibility criteria for Study ABP-20001 and was improperly enrolled or randomized in that study.
  • Failure to successfully complete the Study ABP-20001, including the following:
  • use of prohibited medications
  • delay of >4 weeks in receiving second Study ABP-20001 investigational study drug injection
  • completing fewer than 75% of eDiary entries during the 28-week treatment and follow-up periods
  • 7 or more consecutive missed days of eDiary entries Note: if the investigator determines that any of the above 4 failures occurred due to extenuating circumstances, patients may be allowed to enroll in Study ABP-20002 if the investigator expects the problem will not recur.
Show all 34Show fewer
  • 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 as evaluated by the investigator.
  • Lifetime history of psychosis, mania, or dementia.
  • History of addiction, including alcohol or drug abuse since initiating ABP-20001 study treatment.
  • Any infection or clinically significant skin problem in any of the injection sites.
  • 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 signing the ICF, 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 time since enrolling in Study ABP-20001.
  • Prior/Concomitant Medications and Treatments
  • Injection with anesthesia or steroids in the targeted muscles since initiating ABP-20001 study treatment.
  • Use of opioids or barbiturates >2 days per month since initiating ABP-20001 study treatment.
  • Use of CBD or other types of cannabinoids since initiating ABP-20001 study treatment.
  • Use of botulinum toxin for migraine or any other medical reasons, including cosmetic use, at or above the shoulders outside of Study ABP-20001 since initiating ABP-20001 study treatment and throughout Study ABP-20002.
  • Any CGRP inhibitor treatment (eg, erenumab [Aimovig®], eptinezumab [Vyepti®], fremanezumab [Ajovy®], or galcanezumab [Emgality®], rimegepant sulfate [Nurtec™], ubrogepant [Ubrelvy™] within or outside of a clinical study) since initiating ABP-20001 study treatment.
  • Use of small molecule migraine drugs (eg, beta-blockers, anticonvulsants, antidepressants, calcium channel blockers) since initiating ABP-20001 study treatment.
  • 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) since initiating ABP-20001 study treatment.
  • 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 since initiating ABP-20001 study treatment 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.
  • Participation in another interventional study since initiating ABP-20001 study treatment. Other Exclusion Criteria:
  • Patients who have been infected with COVID-19 for whom the infection worsened their migraine disorder. Patients for whom infection with COVID-19 did not worsen their migraine disorder may be included in the study.
  • Female patients pregnant or planning on becoming pregnant during the study and/or lactating/breastfeeding.
  • Patient is an employee or family member of the investigator, study site personnel, PPD, or AEON.

Trial locations and contacts

55 sites in 3 countries.

55 sites in 3 countries

United States48 sites

  • Albuquerque Clinical Trials Inc - Clinedge - PPDS

    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

  • Boston Clinical Trials Inc

    Boston, Massachusetts, 02131

  • 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

  • Alina 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

  • 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, 89104

  • Los Angeles Headache Center

    Los Angeles, California, 90067

  • Drug Studies America, Inc

    Marietta, Georgia, 30060

  • Legacy Clinical Solutions: Tandem Clinical Research, LLC - Clinedge - PPDS

    Marrero, Louisiana, 70072

  • Velocity Clinical Research - Boise - ERN - PPDS

    Meridian, Idaho, 83642

  • BioMed Research Institute, INC

    Miami, Florida, 33126

  • Bryant Research Group

    Nashville, Tennessee, 37203

  • The Orthopedic Foundation

    New Albany, Ohio, 43054

  • 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

  • Houston Neurology Associates

    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

Canada4 sites

  • True North Clinical Research

    Halifax, Nova Scotia, B3S 1N2

  • Diex Recherche Québec

    Québec, G1N 4V3

  • CARe Clinic

    Red Deer, Alberta, T4P 1K4

  • Bluewater Clinical Research Group

    Sarnia, Ontario, N7T 4X3

Other trials in Canada

Australia3 sites

  • Emeritus Research

    Camberwell, Victoria, 3124

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Alfred Hospital

    Melbourne, Victoria, 3004

Other trials in Australia

About this study

Official title: A Randomized, Multicenter, Dose-Blinded, Phase 2 Extension Study of ABP-450 (prabotulinumtoxinA) Purified Neurotoxin Complex for the Prevention of Migraine Headache

This Phase 2 Extension 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 approximately 666 patients across approximately 65 sites in the United States, Canada and Australia from the Phase 2 trial. Study subjects will be divided evenly across a low dose group and a high dose group. All patients will receive four treatment cycles of ABP-450 utilizing the Company's novel injection paradigm.

Read the detailed description

The Phase 2 Extension 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 approximately 666 patients across approximately 65 sites in the United States, Canada and Australia from Phase 2 trial. Study subjects who had their initial dose of study drug in Phase 2 trial study, irrespective of treatment allocation, will be eligible to enroll in this extension study. Study subjects will be divided evenly across a group receiving a low dose of ABP-450 and a group receiving a high dose of ABP-450. All patients will receive four 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
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.

Study groups in NCT05016661
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

What is being measured

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

  1. Incidence of Treatment Emergent Adverse Events

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

    Measured: Baseline to Week 52 - End of Study

  2. Change in Monthly Migraine Days

    The primary efficacy endpoint will be the change in mean Monthly Migraine Days (MMD) from Baseline to intervals throughout the study.

    Measured: Baseline to Week 52 - End of Treatment Period

Secondary outcomes (6)

  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 throughout the study will be assessed by Treatment Group.

    Measured: Baseline to Week 52 - End of Study

  2. 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 52 - End of Study

  3. 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 52 - End of Study

  4. 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 52 - End of Study

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

    Percentage of Participants with Suicidal Ideation and Behaviors will be assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) with the suicidal ideation on a 5-point scale, ranging from "wish to be dead" to "activesuidical ideatikon with specific plan and intert" and suicidal behaviors of a 4-point scale ranging from "preparatory acts or behavior" to "actual attempt" in lifetime, past 3 months, and since last visit. The higher total scores indicate more suicidal ideation and /or suicidal behavior.

    Measured: Baseline to Week 52 - End of Study

  6. 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 52 - 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 posted23 Aug 2021
  2. Study start19 Oct 2021
  3. Primary completion31 Jul 2024
  4. Study completion30 Aug 2024

Why it stopped: Study was terminated due to the analysis of the data not meeting the intended primary endpoint and key secondary endpoints.

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 666 patients will be randomized in a 1:1 ratio and receive 1 of the following treatments: ABP-450 Low Dose or ABP-450 High Dose via intramuscular injection into pre-specified areas of the head and neck.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
466 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05016661
Sponsor's protocol ID
ABP-20002
Status last verified
Sep 2024
First submitted
17 Aug 2021
Last updated
20 Sep 2024
Results posted
No
Data monitoring committee
No
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 a 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 55 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 6 inclusion and 34 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: stopped early, as of the sponsor's last update on 20 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 55 sites in United States, Canada, Australia. 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. 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 was stopped early (reason given: Study was terminated due to the analysis of the data not meeting the intended primary endpoint and key secondary endpoints.). Results are not available in the source record.

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?

Incidence of Treatment Emergent Adverse Events (time frame: Baseline to Week 52 - End of Study). 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 NCT05016661.

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 20 Sep 2024.

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