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

NCT04845178 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: ABP-20001
• Study Type: interventional
• Target: 797
• Locations: 3 countries
• Sites: 62

Brief 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. 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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline to Weeks 21 to 24 Treatment period.

• 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).

  Baseline to Week 28 - End of Study.

Secondary Outcomes (9)

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

  Baseline to Week 28 - End of Study.

• Mean change in Monthly Migraine Days (MMD)

  Baseline to Week 28 - End of Study.

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

  Baseline to Week 28 - End of Study.

• Mean change in Headache Hours

  Baseline to Week 28 - End of Study.

• Mean Change in Monthly Headache Days

  Baseline to Week 28 - End of Study.

Other Outcomes (4)

• Mean Change in Patient Global Impression of Change (PGI-C) Score

  Baseline to Week 28 - End of Study.

• Mean Change in Patient Global Impression of Severity (PGI-S) Score

  Baseline to Week 28 - End of Study.

• Mean Change in MIgraine Disability Assessment Score (MIDAS) Total Score

  Baseline to Week 28 - End of Study.

Study Arms (3)

ABP-450 - Low Dose

EXPERIMENTAL

ABP-450 Low Dose - intramuscular injections into specified muscles.

Drug: ABP-450

ABP-450 - High Dose

EXPERIMENTAL

ABP-450 High Dose - intramuscular injections into specified muscles.

Drug: ABP-450

Placebo

PLACEBO COMPARATOR

Placebo (0.9% saline, sterile, unpreserved, USP/Ph.Eur) intramuscular injections into specified muscles.

Drug: Placebo

Interventions

ABP-450 DRUG

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

Also known as: prabotulinumtoxinA

ABP-450 - High Dose; ABP-450 - Low Dose

Placebo DRUG

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

Also known as: 0.9% sodium chloride, saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• AEON Biopharma, Inc.: lead
• PPD Development, LP: collaborator

Study Sites (62)

MDFirst Research

Chandler, Arizona, 85226, United States

Location

Elite Clinical Studies, LLC

Phoenix, Arizona, 85018, United States

Location

Arizona Neuroscience Research

Phoenix, Arizona, 85032, United States

Location

Clinical Research Consortium Arizona

Tempe, Arizona, 85281, United States

Location

Axiom Research LLC

Colton, California, 92324, United States

Location

Velocity Research San Diego

La Mesa, California, 91942, United States

Location

Collaborative Neuroscience Research

Long Beach, California, 90806, United States

Location

Los Angeles Headache Center

Los Angeles, California, 90067, United States

Location

Anderson Clinical Research

Redlands, California, 92374, United States

Location

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

San Diego, California, 92103, United States

Location

Delta Waves LLC - Hunt - PPDS

Colorado Springs, Colorado, 80918, United States

Location

Paradigm Clinical Research Centers

Wheat Ridge, Colorado, 80033, United States

Location

New England Institute for Neurology and Headache

Stamford, Connecticut, 06905, United States

Location

Quality Research of South Florida

Hialeah, Florida, 33016, United States

Location

Sandhill Research, LLC

Lake Mary, Florida, 32746, United States

Location

Canvas Clinical Research

Lake Worth, Florida, 33467, United States

Location

BioMed Research Institute, INC

Miami, Florida, 33126, United States

Location

Medical Research Center, LLC

Miami, Florida, 33144, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

Innovation Medical Research Center

Palmetto Bay, Florida, 33157, United States

Location

Clinical Research of Central Florida - ClinEdge - PPDS

Winter Haven, Florida, 33810, United States

Location

NeuroTrials Research Inc. - Clinedge - PPDS

Atlanta, Georgia, 30328, United States

Location

Drug Studies America, Inc

Marietta, Georgia, 30060, United States

Location

Velocity Clinical Research - Boise - ERN - PPDS

Meridian, Idaho, 83642, United States

Location

Cedar Crosse Research Center

Chicago, Illinois, 60607, United States

Location

Kansas Institute of Research, LLC

Overland Park, Kansas, 66211, United States

Location

Crescent City Headache and Neurology Center

Chalmette, Louisiana, 70043, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

Boston Clinical Trials Inc

Boston, Massachusetts, 02131, United States

Location

MedVadis Research

Waltham, Massachusetts, 02451, United States

Location

Quest Research Institute - Hunt - PPDS

Farmington Hills, Michigan, 40825, United States

Location

Henry Ford Allegiance Neurology

Jackson, Michigan, 49201, United States

Location

StudyMetrix Research, LLC

City of Saint Peters, Missouri, 63303, United States

Location

Clinvest Research LLC

Springfield, Missouri, 65810, United States

Location

Barrett Clinic, P.C. - Clinedge - PPDS

La Vista, Nebraska, 68128, United States

Location

Quality Clinical Research

Omaha, Nebraska, 68114, United States

Location

Wake Research - CRCN, LLC

Las Vegas, Nevada, 89118, United States

Location

Hassman Research Institute - ClinEdge - PPDS

Berlin, New Jersey, 08009, United States

Location

Albuquerque Clinical Trials Inc

Albuquerque, New Mexico, 87102, United States

Location

Dent Neurologic Institute

Amherst, New York, 14226, United States

Location

New York Neurology Associates

New York, New York, 10003, United States

Location

Upstate Clinical Research Associates LLC

Williamsville, New York, 14221, United States

Location

Dayton Center for Neurological Disorders

Centerville, Ohio, 45459, United States

Location

META Medical Research Institute, LLC

Dayton, Ohio, 45432, United States

Location

Centricity Research Dublin Multispecialty

Dublin, Ohio, 43016, United States

Location

The Orthopedic Foundation

New Albany, Ohio, 43054, United States

Location

Thomas Jefferson University, Jefferson Headache Center

Philadelphia, Pennsylvania, 19107, United States

Location

Preferred Primary Care Physicians

Pittsburgh, Pennsylvania, 15236, United States

Location

WR-ClinSearch

Chattanooga, Tennessee, 37421, United States

Location

Bryant Research Group

Nashville, Tennessee, 37203, United States

Location

DCT - Baxter LLC dba Discovery Clinical Trials

Dallas, Texas, 75225, United States

Location

Mercury Clinical Research Incorporated

Sugar Land, Texas, 77478, United States

Location

Aspen Clinical Research LLC - Clinedge - PPDS

Orem, Utah, 84058, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98004, United States

Location

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Grampians Health

Ballarat, Victoria, 3350, Australia

Location

Emeritus Research

Camberwell, Victoria, 3124, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

CARe Clinic

Red Deer, Alberta, T4P 1K4, Canada

Location

True North Clinical Research

Halifax, Nova Scotia, B3S 1N2, Canada

Location

Bluewater Clinical Research Group

Sarnia, Ontario, N7T 4X3, Canada

Location

Diex Recherche Québec

Québec, Quebec, G1N 4V3, Canada

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

prabotulinumtoxin A; Sodium Chloride

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Richard B Lipton, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

• Stewart J Tepper, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator, study nurse/other study personnel, and patients will be blinded to the treatment group. An appropriately trained person will reconstitute investigational product, fill masked-labeled syringes and provide them to the investigator, but will not perform any assessments with the patient.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: April 14, 2021
• Study Start: March 1, 2021
• Primary Completion: June 19, 2024
• Study Completion: August 6, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (54); AU (4); CA (4)