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

NCT ID: NCT05016661

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 466 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-19
• Study Completion Date: 2024-08-30

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.

Detailed Description

The 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 Phase 2 trial. Study subjects who had their initial dose of study drug in Phase 2 trial study, irrespective of treatment allocation, will be eligible to enroll in this extension study. Study subjects will be divided evenly across a group receiving a low dose of ABP-450 and a group receiving a high dose of ABP-450. All patients will receive four treatment cycles utilizing the Company's novel treatment paradigm involving fewer injections than the current botulinum toxin treatment option for chronic migraine.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

ABP-450 - Low Dose

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

Group Type: EXPERIMENTAL

ABP-450

Intervention Type: DRUG

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

ABP-450 - High Dose

ABP-450 High Dose - intramuscular injections into specified muscles

Group Type: EXPERIMENTAL

ABP-450

Intervention Type: DRUG

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

Interventions

ABP-450

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

Intervention Type: DRUG

Other Intervention Names

prabotulinumtoxinA

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Patient was enrolled in Study ABP-20001 and successfully completed that study's treatment and procedures.

3. 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.

4. A WOCBP must have a negative urine pregnancy test at Visit 1.

5. Patient can read, understand, and complete the eDiary.

6. Patient is willing and able to adhere to the study assessments, visit schedules, and prohibitions, as described in this protocol.

Exclusion Criteria

1. Did not meet eligibility criteria for Study ABP-20001 and was improperly enrolled or randomized in that study.

2. Failure to successfully complete the Study ABP-20001, including the following:

1. use of prohibited medications

2. delay of >4 weeks in receiving second Study ABP-20001 investigational study drug injection

3. completing fewer than 75% of eDiary entries during the 28-week treatment and follow-up periods

4. 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:

3. History of migraine accompanied by diplopia or decreased level of consciousness, or retinal migraine.

4. Current diagnosis of chronic tension-type headache, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or cranial neuropathy.

5. Confounding and clinically significant pain syndromes (eg, fibromyalgia, chronic low back pain, complex regional pain syndromes) as evaluated by the investigator.

6. Diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease that might interfere with the study.

7. Psychiatric conditions that are uncontrolled and/or untreated as evaluated by the investigator.

8. Lifetime history of psychosis, mania, or dementia.

9. History of addiction, including alcohol or drug abuse since initiating ABP-20001 study treatment.

10. Any infection or clinically significant skin problem in any of the injection sites.

11. 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:

12. 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

13. Injection with anesthesia or steroids in the targeted muscles since initiating ABP-20001 study treatment.

14. Use of opioids or barbiturates >2 days per month since initiating ABP-20001 study treatment.

15. Use of CBD or other types of cannabinoids since initiating ABP-20001 study treatment.

16. 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.

17. 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.

18. Use of small molecule migraine drugs (eg, beta-blockers, anticonvulsants, antidepressants, calcium channel blockers) since initiating ABP-20001 study treatment.

19. Use of devices for the treatment of migraine (ie, non-invasive neuromodulation therapies including but not limited to non-invasive nerve stimulation [gammaCore], transcranial magnetic stimulation [Cefaly], external trigeminal nerve stimulation, transcutaneous electrical nerve stimulation, and peripheral neuroelectrical stimulation) since initiating ABP-20001 study treatment.

20. Any other treatments or therapies (eg, acupuncture in head and neck region, cranial traction, nociceptive trigeminal inhibition, occipital nerve block treatments, and dental splints for headache) to the head, neck, or shoulder regions since initiating ABP-20001 study treatment that, in the opinion of the investigator, would interfere with the investigational study drug.

21. History of inadequate response to 3 classes of medications (which have different mechanisms of action) prescribed for the prevention of migraine, excluding CGRP therapies.

22. History of hypersensitivity to human serum albumin, sucrose, or botulinum toxin type A.

24. Patients who have been infected with COVID-19 for whom the infection worsened their migraine disorder. Patients for whom infection with COVID-19 did not worsen their migraine disorder may be included in the study.

25. Female patients pregnant or planning on becoming pregnant during the study and/or lactating/breastfeeding.

26. Patient is an employee or family member of the investigator, study site personnel, PPD, or AEON.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PPD Development, LP

INDUSTRY

Sponsor Role: collaborator

AEON Biopharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard B Lipton, MD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Stewart J Tepper, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

MDFirst Research

Chandler, Arizona, United States

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

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

Marrero, Louisiana, United States

Boston Clinical Trials Inc

Boston, Massachusetts, United States

MedVadis Research

Waltham, Massachusetts, United States

Quest Research Institute - Hunt - PPDS

Farmington Hills, Michigan, United States

StudyMetrix Research, LLC

City of Saint Peters, Missouri, United States

Clinvest Research LLC

Springfield, Missouri, United States

Barrett Clinic, P.C. - Clinedge - PPDS

La Vista, Nebraska, United States

Quality Clinical Research

Omaha, Nebraska, United States

Wake Research - CRCN, LLC

Las Vegas, Nevada, United States

Albuquerque Clinical Trials Inc - Clinedge - PPDS

Albuquerque, New Mexico, United States

Dent Neurologic Institute

Amherst, New York, United States

Upstate Clinical Research Associates LLC

Williamsville, New York, United States

META Medical Research Institute, LLC

Dayton, Ohio, United States

Centricity Research Dublin Multispecialty

Dublin, Ohio, United States

The Orthopedic Foundation

New Albany, Ohio, United States

Thomas Jefferson University, Jefferson Headache Center

Philadelphia, Pennsylvania, United States

Preferred Primary Care Physicians

Pittsburgh, Pennsylvania, United States

WR-ClinSearch

Chattanooga, Tennessee, United States

Bryant Research Group

Nashville, Tennessee, United States

Alina Clinical Trials

Dallas, Texas, United States

Houston Neurology Associates

Sugar Land, Texas, United States

Aspen Clinical Research LLC - Clinedge - PPDS

Orem, Utah, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Liverpool Hospital

Liverpool, New South Wales, Australia

Emeritus Research

Camberwell, Victoria, Australia

Alfred Hospital

Melbourne, Victoria, Australia

CARe Clinic

Red Deer, Alberta, Canada

True North Clinical Research

Halifax, Nova Scotia, Canada

Bluewater Clinical Research Group

Sarnia, Ontario, Canada

Diex Recherche Québec

Québec, , Canada

Countries

United States; Australia; Canada

Other Identifiers

ABP-20002

Identifier Type: -

Identifier Source: org_study_id