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

Sponsor
AEON Biopharma, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04845178
Collaborator
PPD (Industry)
690
Enrollment
55
Locations
3
Arms
29.9
Anticipated Duration (Months)
12.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

The 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 of ABP-450 group, a high dose of ABP-450 group, and a placebo group. All patients will receive two treatment cycles utilizing the Company's novel treatment paradigm involving fewer injections than the current botulinum toxin treatment option for chronic migraine.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
690 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Approximately 690 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.Approximately 690 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.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Prevention
Official Title:
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2 Study of ABP-450 (prabotulinumtoxinA) Purified Neurotoxin Complex for the Prevention of Migraine Headache
Actual Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
May 29, 2023
Anticipated Study Completion Date :
Aug 29, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: ABP-450 - Low Dose

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

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

    		•
    Experimental: ABP-450 - High Dose

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

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

    		•
    Placebo Comparator: Placebo

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

    Drug: Placebo
    0.9% sodium chloride, sterile, unpreserved, USP/PhEur
    Other Names:
  • 0.9% sodium chloride
  • saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Treatment Emergent Adverse Events [Baseline to Week 28 - End of Study.]

      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).

    2. Change in Monthly Migraine Days [Baseline to Weeks 21 to 24 Treatment period.]

      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.

    Secondary Outcome Measures

    1. Suicidality by Columbia-Suicide Severity Rating Scale (C-SSRS) [Baseline to Week 28 - End of Study.]

      Percentage of patients with Suicidal Ideation and Behaviors will be assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS).

    2. Development of Anti-Drug Antibodies (ADA) to ABP-450 [Baseline to Week 28 - End of Study.]

      Percentage of patients developing Anti-Drug Antibodies to ABP-450 antibodies (binding and if positive, neutralizing) will be assessed.

    3. Percentage of Patients with Reduction in Mean Migraine Days (MMD) [Baseline to Week 28 - End of Study.]

      Percentage of patients with a reduction from Baseline of ≥ 50 percent, ≥ 75 percent and 100% percent in average number of MMD will be assessed by Treatment Group.

    4. Mean change in Monthly Migraine Days (MMD) [Baseline to Week 28 - End of Study.]

      Overall mean change from Baseline in the number of MMD will be assessed by Treatment Group.

    5. Mean change in Monthly Migraine Days (MMD) requiring medications for acute treatment of migraine or headaches [Baseline to Week 28 - End of Study.]

      Overall mean change from Baseline in number of MMD requiring migraine specific medication and non-specific medications for the acute treatment of migraine or headache will be assessed by Treatment Group.

    6. Mean change in Headache Hours [Baseline to Week 28 - End of Study.]

      Overall mean change from Baseline in headache (either moderate or severe) hours will be assessed by Treatment Group.

    7. Mean Change in Monthly Headache Days [Baseline to Week 28 - End of Study.]

      Overall mean change from Baseline in monthly headache days will be assessed by Treatment Group.

    Other Outcome Measures

    1. Mean change of Migraine-Specific-Quality of Life (MSQ) Domaines [Through study completion, an average of 6 months]

      The Mean Change in Migraine-Specific-Quality of Life (MSQ), a 14-item assessment, with each item rated on a 6-point scale (ranging from "none of the time" to "all of the time") with higher scores indicating better quality of life will be assessed by Treatment Group.

    2. Mean Change in Patient Global Impression of Change (PGI-C) Score [Baseline to Week 28 - End of Study.]

      The Mean change in the subject's assessment of the change in clinical status since the start of treatment measured by the Patients' Global Impression of Change (PGI-C) Scale will be assessed by Treatment Group.

    3. Mean Change in Patient Global Impression of Severity (PGI-S) Score [Baseline to Week 28 - End of Study.]

      The Mean change in the subject's assessment of the severity of their condition since the start of treatment measured by the Patients' Global Impression of Severity (PGI-S) Scale will be assessed by Treatment Group.

    4. Mean Change in MIgraine Disability Assessment Score (MIDAS) Total Score [Baseline to Week 28 - End of Study.]

      The Mean Change in the Migraine Disability Assessment Scale (MIDAS) between Baseline and End of Treatment assessed by Treatment Group. MIDAS is a 5-item self-administered questionnaire. The 5 items sum to a total MIDAS score of 0 to 155. A higher score indicates greater headache-related disability (worse score).

    5. Percentage of Patients with Reduction in Migraine Physical Function Impact Diary (MPFID) [Baseline to Week 28 - End of Study.]

      Percentage of patients with a reduction from Baseline in the impact on Migraine Physical Function Impact Diary (MPFID) will be assessed by Treatment Group.

    6. Percentage of Patients with Reduction in the Physical Impairment Domaine Score of the Migraine Physical Function Impact Diary (MPFID) [Baseline to Week 28 - End of Study.]

      Percentage of patients with a reduction from Baseline on Physical Impairment Domain Score measured by Migraine Physical Function Impact Diary (MPFID) assessed by Treatment Group.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. 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.

    2. Male or female patients 18 years or older of age (no upper age limit) at the time of signing the informed consent.

    3. 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.

    4. Age of the patient at the time of migraine onset <50 years.

    5. History of, on average ≥6 migraine or probable migraine days per month in the 3 months prior to Screening.

    6. 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.

    7. 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.

    8. A WOCBP must have a negative pregnancy test at Screening.

    9. Patient is able to read, understand, and complete the eDiary.

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

    Exclusion Criteria:

    Medical Conditions

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

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

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

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

    5. 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.

    6. History of addiction, including alcohol or drugs of abuse, within 6 months prior to Screening.

    7. 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.

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

    2. Have been injected with anesthesia or steroids in the targeted muscles during the 30 days immediately prior to initiation of the Baseline period (Section 5.8.1).

    3. 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

    1. 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.

    2. Body mass index ≥38 kg/m2 at Screening.

    3. Use of opioids or barbiturates >2 days per month in the 3 months prior to Screening.

    4. Use of CBD or other types of cannabinoids in the 3 months prior to Screening and throughout the study.

    5. Any use of botulinum toxin for migraine or any other medical reasons within 4 months prior to Screening and during the Screening and Baseline periods.

    6. Any monoclonal antibody CGRP inhibitor treatment (within or outside of a clinical study) within 6 months prior to Screening and throughout the study.

    7. Any orally administered non-peptide CGRP antagonists (within or outside of a clinical study) within 4 weeks prior to the Baseline period and throughout the study.

    8. 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 [cephaly], external trigeminal nerve stimulation, transcutaneous electrical nerve stimulation, and peripheral neuroelectrical stimulation) during Screening and throughout the study.

    9. 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 during Screening and throughout the study that, in the opinion of the investigator, would interfere with the investigational study drug.

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

    11. History of hypersensitivity to human serum albumin, sucrose, or botulinum toxin type A or a positive test for botulinum toxin type A antibody.

    12. Participation in another interventional study within 6 months prior to Screening and throughout the study.

    Prior/Concomitant Medications and Treatments

    1. Female patients planning on becoming pregnant during the course of the study and/or lactating/breastfeeding.

    2. Patient has donated or lost a significant volume (>450 mL) of blood or plasma within 30 days of screening.

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MDFirst Research Chandler Arizona United States 85226
    2 Elite Clinical Studies, LLC Phoenix Arizona United States 85018
    3 Arizona Neuroscience Research Phoenix Arizona United States 85032
    4 Clinical Research Consortium Arizona Tempe Arizona United States 85281
    5 Axiom Research LLC Colton California United States 92324
    6 Collaborative Neuroscience Research Long Beach California United States 90806
    7 Los Angeles Headache Center Los Angeles California United States 90067
    8 Anderson Clinical Research Redlands California United States 92374
    9 Artemis Institute For Clinical Research LLC - San Diego - ClinEdge - PPDS San Diego California United States 92103
    10 Delta Waves LLC - Hunt - PPDS Colorado Springs Colorado United States 80918
    11 Paradigm Clinical Research Centers Wheat Ridge Colorado United States 80033
    12 Coastal Connecticut Research, LLC - ClinEdge - PPDS New London Connecticut United States 06320
    13 New England Institute for Neurology and Headache Stamford Connecticut United States 06905
    14 Community Research of South Florida Hialeah Florida United States 33016
    15 Canvas Clinical Research Lake Worth Florida United States 33467
    16 BioMed Research Institute, INC Miami Florida United States 33126
    17 Medical Research Center, LLC Miami Florida United States 33144
    18 Renstar Medical Research Ocala Florida United States 34470
    19 Innovation Medical Research Center Palmetto Bay Florida United States 33157
    20 Clinical Research of Central Florida - ClinEdge - PPDS Winter Haven Florida United States 33810
    21 NeuroTrials Research Inc. - Clinedge - PPDS Atlanta Georgia United States 30328
    22 NeuroStudies.net Decatur Georgia United States 30033
    23 Drug Studies America, Inc Marietta Georgia United States 30060
    24 Velocity Clinical Research - Boise - ERN - PPDS Meridian Idaho United States 83642
    25 Kansas Institute of Research, LLC Overland Park Kansas United States 66211
    26 Legacy Clinical Solutions: Tandem Clinical Research, LLC - Clinedge - PPDS Marrero Louisiana United States 70072
    27 Boston Clinical Trials Inc Boston Massachusetts United States 02131
    28 Quest Research Institute - Hunt - PPDS Farmington Hills Michigan United States 40825
    29 Henry Ford Allegiance Neurology Jackson Michigan United States 49201
    30 StudyMetrix Research, LLC Saint Peters Missouri United States 63303
    31 Clinvest Research LLC Springfield Missouri United States 65810
    32 Barrett Clinic, P.C. - Clinedge - PPDS La Vista Nebraska United States 68128
    33 Quality Clinical Research Omaha Nebraska United States 68114
    34 Wake Research - CRCN, LLC Las Vegas Nevada United States 89104
    35 Hassman Research Institute - ClinEdge - PPDS Berlin New Jersey United States 08009
    36 Albuquerque Clinical Trials Inc - Clinedge - PPDS Albuquerque New Mexico United States 87102
    37 Dent Neurologic Institute Amherst New York United States 14226
    38 Upstate Clinical Research Associates LLC Williamsville New York United States 14221
    39 META Medical Research Institute, LLC Dayton Ohio United States 45432
    40 The Orthopedic Foundation New Albany Ohio United States 43054
    41 Thomas Jefferson University, Jefferson Headache Center Philadelphia Pennsylvania United States 19107
    42 Preferred Primary Care Physicians Pittsburgh Pennsylvania United States 15236
    43 DCT - Baxter LLC dba Discovery Clinical Trials Dallas Texas United States 75225
    44 Mercury Clinical Research Incorporated Sugar Land Texas United States 77478
    45 Aspen Clinical Research LLC - Clinedge - PPDS Orem Utah United States 84058
    46 Northwest Clinical Research Center Bellevue Washington United States 98004
    47 Liverpool Hospital Liverpool New South Wales Australia 2170
    48 Ballarat Health Services Ballarat Victoria Australia 3350
    49 Emeritus Research Camberwell Victoria Australia 3124
    50 Alfred Hospital Melbourne Victoria Australia 3004
    51 CARe Clinic Red Deer Alberta Canada T4P 1K4
    52 True North Clinical Research Halifax Nova Scotia Canada B3S 1N2
    53 Kingston Health Science Center Kingston Ontario Canada K7L 2V7
    54 Bluewater Clinical Research Group Sarnia Ontario Canada N7T 4X3
    55 Diex Recherche Québec Québec Canada G1N 4V3

    Sponsors and Collaborators

    • AEON Biopharma, Inc.
    • PPD

    Investigators

    • Principal Investigator: Richard B Lipton, MD, Albert Einstein College of Medicine
    • Principal Investigator: Stewart J Tepper, MD, Dartmouth-Hitchcock Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AEON Biopharma, Inc.
    ClinicalTrials.gov Identifier:
    NCT04845178
    Other Study ID Numbers:
    • ABP-20001
    First Posted:
    Apr 14, 2021
    Last Update Posted:
    Jul 26, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Migraine Disorders

    Study Results

    No Results Posted as of Jul 26, 2022