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

Completed · Phase 2 · Has a placebo group

Conditions studied: Migraine

In brief

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.

Key facts

Study ID

NCT04845178

Run by

AEON Biopharma, Inc.

People needed

797

Starts

2021-03-01

Expected to finish

2024-08-06

Last updated by the study team

2024-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• Elite Clinical Studies, LLC — Phoenix, Arizona, United States
• Arizona Neuroscience Research — Phoenix, Arizona, United States
• Clinical Research Consortium Arizona — Tempe, Arizona, United States
• Axiom Research LLC — Colton, California, United States
• Velocity Research San Diego — La Mesa, California, United States
• Collaborative Neuroscience Research — Long Beach, California, United States
• Los Angeles Headache Center — Los Angeles, California, United States
• Anderson Clinical Research — Redlands, California, United States
• Artemis Institute For Clinical Research LLC - San Diego - ClinEdge - PPDS — San Diego, California, United States
• Delta Waves LLC - Hunt - PPDS — Colorado Springs, Colorado, United States
• Paradigm Clinical Research Centers — Wheat Ridge, Colorado, United States
• New England Institute for Neurology and Headache — Stamford, Connecticut, United States
• Quality Research of South Florida — Hialeah, Florida, United States
• Sandhill Research, LLC — Lake Mary, Florida, United States
• Canvas Clinical Research — Lake Worth, Florida, United States
• BioMed Research Institute, INC — Miami, Florida, United States
• Medical Research Center, LLC — Miami, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Innovation Medical Research Center — Palmetto Bay, Florida, United States
• Clinical Research of Central Florida - ClinEdge - PPDS — Winter Haven, Florida, United States
• NeuroTrials Research Inc. - Clinedge - PPDS — Atlanta, Georgia, United States
• Drug Studies America, Inc — Marietta, Georgia, United States
• Velocity Clinical Research - Boise - ERN - PPDS — Meridian, Idaho, United States
• Cedar Crosse Research Center — Chicago, Illinois, United States
• MDFirst Research — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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