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

Who is this study for? Patients with chronic migraine
What treatments are being studied? ABP-450
Status: Recruiting
Location: See all (54) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 690 patients across approximately 60 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Patient can understand the eICF, provides signed eICF 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.

Locations
United States
Arizona
MDFirst Research
Recruiting
Chandler
Arizona Neuroscience Research
Recruiting
Phoenix
Elite Clinical Studies, LLC
Recruiting
Phoenix
Clinical Research Consortium Arizona
Recruiting
Tempe
California
Axiom Research LLC
Recruiting
Colton
Collaborative Neuroscience Research
Recruiting
Long Beach
Los Angeles Headache Center
Recruiting
Los Angeles
Anderson Clinical Research
Recruiting
Redlands
Artemis Institute For Clinical Research LLC - San Diego - ClinEdge - PPDS
Recruiting
San Diego
Colorado
Delta Waves LLC - Hunt - PPDS
Recruiting
Colorado Springs
Paradigm Clinical Research Centers
Recruiting
Wheat Ridge
Connecticut
Coastal Connecticut Research, LLC - ClinEdge - PPDS
Recruiting
New London
New England Institute for Neurology and Headache
Recruiting
Stamford
Florida
Community Research of South Florida
Recruiting
Hialeah
Sandhill Research, LLC
Recruiting
Lake Mary
Canvas Clinical Research
Recruiting
Lake Worth
BioMed Research Institute, INC
Recruiting
Miami
Medical Research Center, LLC
Recruiting
Miami
Renstar Medical Research
Recruiting
Ocala
Innovation Medical Research Center
Recruiting
Palmetto Bay
Clinical Research of Central Florida - ClinEdge - PPDS
Recruiting
Winter Haven
Georgia
NeuroTrials Research Inc. - Clinedge - PPDS
Recruiting
Atlanta
Drug Studies America, Inc
Recruiting
Marietta
Idaho
Velocity Clinical Research - Boise - ERN - PPDS
Recruiting
Meridian
Kansas
Kansas Institute of Research, LLC
Recruiting
Overland Park
Louisiana
Tandem Clinical Research
Recruiting
Marrero
Massachusetts
Boston Clinical Trials Inc
Recruiting
Boston
Michigan
Quest Research Institute - Hunt - PPDS
Recruiting
Farmington Hills
Henry Ford Allegiance Neurology
Recruiting
Jackson
Missouri
StudyMetrix Research, LLC
Recruiting
Saint Peters
Clinvest Research LLC
Recruiting
Springfield
Nebraska
Barrett Clinic, P.C. - Clinedge - PPDS
Recruiting
La Vista
Quality Clinical Research
Recruiting
Omaha
New Jersey
Hassman Research Institute - ClinEdge - PPDS
Recruiting
Berlin
New Mexico
Albuquerque Clinical Trials Inc - Clinedge - PPDS
Recruiting
Albuquerque
Nevada
Wake Research - CRCN, LLC
Recruiting
Las Vegas
New York
Dent Neurologic Institute
Recruiting
Amherst
Upstate Clinical Research Associates LLC
Recruiting
Williamsville
Ohio
META Medical Research Institute, LLC
Recruiting
Dayton
The Orthopedic Foundation
Recruiting
New Albany
Pennsylvania
Thomas Jefferson University, Jefferson Headache Center
Recruiting
Philadelphia
Preferred Primary Care Physicians
Recruiting
Pittsburgh
Texas
DCT - Baxter LLC dba Discovery Clinical Trials
Recruiting
Dallas
Mercury Clinical Research Incorporated
Recruiting
Sugar Land
Utah
Aspen Clinical Research LLC - Clinedge - PPDS
Recruiting
Orem
Washington
Northwest Clinical Research Center
Recruiting
Bellevue
Other Locations
Australia
Ballarat Health Services
Recruiting
Ballarat
Emeritus Research
Recruiting
Camberwell
Liverpool Hospital
Recruiting
Liverpool
Alfred Hospital
Recruiting
Melbourne
Canada
True North Clinical Research
Recruiting
Halifax
Diex Recherche Québec
Recruiting
Québec
CARe Clinic
Recruiting
Red Deer
Bluewater Clinical Research Group
Recruiting
Sarnia
Contact Information
Primary
Marcio Torres, MD
mt@aeonbiopharma.com
888-602-1142
Time Frame
Start Date: March 1, 2021
Estimated Completion Date: February 13, 2024
Participants
Target number of participants: 690
Treatments
Experimental: ABP-450 - Low Dose
ABP-450 Low Dose - intramuscular injections into specified muscles.
Experimental: ABP-450 - High Dose
ABP-450 High Dose - intramuscular injections into specified muscles.
Placebo Comparator: Placebo
Placebo (0.9% saline, sterile, unpreserved, USP/Ph.Eur) intramuscular injections into specified muscles.
Related Therapeutic Areas
Sponsors
Collaborators: PPD
Leads: AEON Biopharma, Inc.

This content was sourced from clinicaltrials.gov

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