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

Who is this study for? Adults who suffer from six or more migraine days per month
What treatments are being studied? ABP-450
Status: Enrolling by invitation
Location: See all (49) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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. 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.

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

• 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 (Appendix 13.3).

• A WOCBP (Appendix 13.3) 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.

Locations
United States
Arizona
MDFirst Research
Chandler
Arizona Neuroscience Research
Phoenix
Elite Clinical Studies, LLC
Phoenix
Clinical Research Consortium Arizona
Tempe
California
Axiom Research LLC
Colton
Los Angeles Headache Center
Los Angeles
Anderson Clinical Research
Redlands
Artemis Institute For Clinical Research LLC - San Diego - ClinEdge - PPDS
San Diego
Colorado
Delta Waves LLC - Hunt - PPDS
Colorado Springs
Paradigm Clinical Research Centers
Wheat Ridge
Connecticut
Coastal Connecticut Research, LLC - ClinEdge - PPDS
New London
New England Institute for Neurology and Headache
Stamford
Florida
Community Research of South Florida
Hialeah
Sandhill Research, LLC
Lake Mary
Canvas Clinical Research
Lake Worth
BioMed Research Institute, INC
Miami
Medical Research Center, LLC
Miami
Renstar Medical Research
Ocala
Innovation Medical Research Center
Palmetto Bay
Clinical Research of Central Florida - ClinEdge - PPDS
Winter Haven
Georgia
NeuroTrials Research Inc. - Clinedge - PPDS
Atlanta
Drug Studies America, Inc
Marietta
Idaho
Velocity Clinical Research - Boise - ERN - PPDS
Meridian
Kansas
Kansas Institute of Research, LLC
Overland Park
Louisiana
Legacy Clinical Solutions: Tandem Clinical Research, LLC - Clinedge - PPDS
Marrero
Massachusetts
Boston Clinical Trials Inc
Boston
Michigan
Quest Research Institute - Hunt - PPDS
Farmington Hills
Missouri
StudyMetrix Research, LLC
Saint Peters
Clinvest Research LLC
Springfield
Nebraska
Barrett Clinic, P.C. - Clinedge - PPDS
La Vista
Quality Clinical Research
Omaha
New Mexico
Albuquerque Clinical Trials Inc - Clinedge - PPDS
Albuquerque
Nevada
Wake Research - CRCN, LLC
Las Vegas
New York
Dent Neurologic Institute
Amherst
Upstate Clinical Research Associates LLC
Williamsville
Ohio
META Medical Research Institute, LLC
Dayton
The Orthopedic Foundation
New Albany
Pennsylvania
Thomas Jefferson University, Jefferson Headache Center
Philadelphia
Preferred Primary Care Physicians
Pittsburgh
Texas
DCT - Baxter LLC dba Discovery Clinical Trials
Dallas
Mercury Clinical Research Incorporated
Sugar Land
Utah
Aspen Clinical Research LLC - Clinedge - PPDS
Orem
Washington
Northwest Clinical Research Center
Bellevue
Other Locations
Australia
Emeritus Research
Camberwell
Alfred Hospital
Melbourne
Canada
True North Clinical Research
Halifax
Diex Recherche Québec
Québec
CARe Clinic
Red Deer
Bluewater Clinical Research Group
Sarnia
Time Frame
Start Date: October 19, 2021
Estimated Completion Date: July 30, 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
Related Therapeutic Areas
Sponsors
Collaborators: PPD
Leads: AEON Biopharma, Inc.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials