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

Stopped early · Phase 2

Conditions studied: Migraine

In brief

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.

Key facts

Study ID

NCT05016661

Run by

AEON Biopharma, Inc.

People needed

466

Starts

2021-10-19

Expected to finish

2024-08-30

Last updated by the study team

2024-09-20

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.
• 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.

You may not qualify if…

• 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.
• 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.

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
• 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
• 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
• Kansas Institute of Research, LLC — Overland Park, Kansas, United States
• Crescent City Headache and Neurology Center — Chalmette, Louisiana, United States
• MDFirst Research — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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