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

NCT05016661 | Terminated Phase 2 FDA Drug

• 1 other identifier: ABP-20002
• Study Type: interventional
• Target: 466
• Locations: 3 countries
• Sites: 55

Brief 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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment Emergent Adverse Events

  The primary safety endpoint will be the incidence of TEAEs throughout the study when dosed with ABP-450 (low dose) or ABP-450 (high dose).

  Baseline to Week 52 - End of Study

• Change in Monthly Migraine Days

  The primary efficacy endpoint will be the change in mean Monthly Migraine Days (MMD) from Baseline to intervals throughout the study.

  Baseline to Week 52 - End of Treatment Period

Secondary Outcomes (6)

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

  Baseline to Week 52 - End of Study

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

  Baseline to Week 52 - End of Study

• Mean change in Headache Hours

  Baseline to Week 52 - End of Study

• Mean Change in Monthly Headache Days

  Baseline to Week 52 - End of Study

• Suicidality by Columbia-Suicide Severity Rating Scale (C-SSRS)

  Baseline to Week 52 - End of Study

Other Outcomes (6)

• Mean change of Migraine-Specific-Quality of Life (MSQ) Domains

  Baseline to Week 52 - End of Study

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

  Baseline to Week 52 - End of Study

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

  Baseline to Week 52 - End of Study

Study Arms (2)

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

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

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.
• 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
• 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.

Sponsors & Collaborators

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

Study Sites (55)

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

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

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

Legacy Clinical Solutions: Tandem Clinical Research, LLC - Clinedge - PPDS

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

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, 89104, United States

Location

Albuquerque Clinical Trials Inc - Clinedge - PPDS

Albuquerque, New Mexico, 87102, United States

Location

Dent Neurologic Institute

Amherst, New York, 14226, United States

Location

Upstate Clinical Research Associates LLC

Williamsville, New York, 14221, 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

Alina Clinical Trials

Dallas, Texas, 75225, United States

Location

Houston Neurology Associates

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

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, G1N 4V3, Canada

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

prabotulinumtoxin A

Condition Hierarchy (Ancestors)

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

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 666 patients will be randomized in a 1:1 ratio and receive 1 of the following treatments: ABP-450 Low Dose or ABP-450 High Dose via intramuscular injection into pre-specified areas of the head and neck.

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 23, 2021
• Study Start: October 19, 2021
• Primary Completion: July 31, 2024
• Study Completion: August 30, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3); CA (4); US (48)