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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04845178




Registration number
NCT04845178
Ethics application status
Date submitted
28/03/2021
Date registered
14/04/2021

Titles & IDs
Public title
Investigation of Safety and Efficacy of ABP-450 for Migraine Prevention in Adults
Scientific title
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2 Study of ABP-450 (prabotulinumtoxinA) Purified Neurotoxin Complex for the Prevention of Migraine Headache
Secondary ID [1] 0 0
ABP-20001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABP-450
Treatment: Drugs - Placebo

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.


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

Treatment: Drugs: Placebo
0.9% sodium chloride, sterile, unpreserved, USP/PhEur
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Monthly Migraine Days
Timepoint [1] 0 0
Baseline to Weeks 21 to 24 Treatment period.
Primary outcome [2] 0 0
Incidence of Treatment Emergent Adverse Events
Timepoint [2] 0 0
Baseline to Week 28 - End of Study.
Secondary outcome [1] 0 0
Percentage of Patients with Reduction in Mean Migraine Days (MMD)
Timepoint [1] 0 0
Baseline to Week 28 - End of Study.
Secondary outcome [2] 0 0
Mean change in Monthly Migraine Days (MMD)
Timepoint [2] 0 0
Baseline to Week 28 - End of Study.
Secondary outcome [3] 0 0
Mean change in Monthly Migraine Days (MMD) requiring medications for acute treatment of migraine or headaches
Timepoint [3] 0 0
Baseline to Week 28 - End of Study.
Secondary outcome [4] 0 0
Mean change in Headache Hours
Timepoint [4] 0 0
Baseline to Week 28 - End of Study.
Secondary outcome [5] 0 0
Mean Change in Monthly Headache Days
Timepoint [5] 0 0
Baseline to Week 28 - End of Study.
Secondary outcome [6] 0 0
Mean change of Migraine-Specific-Quality of Life (MSQ) Domains
Timepoint [6] 0 0
Baseline to Week 28 - End of Study.
Secondary outcome [7] 0 0
Percentage of Patients with Reduction in Migraine Physical Function Impact Diary (MPFID)
Timepoint [7] 0 0
Baseline to Week 28 - End of Study.
Secondary outcome [8] 0 0
Suicidality by Columbia-Suicide Severity Rating Scale (C-SSRS)
Timepoint [8] 0 0
Baseline to Week 28 - End of Study.
Secondary outcome [9] 0 0
Development of Anti-Drug Antibodies (ADA) to ABP-450
Timepoint [9] 0 0
Baseline to Week 28 - End of Study.

Eligibility
Key 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. 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.
8. Any infection or clinically significant skin problem in any of the injection sites.
9. Have been injected with anesthesia or steroids in the targeted muscles during the 30 days immediately prior to initiation of the Baseline period.
10. 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
11. 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.
12. Body mass index =38 kg/m2 at Screening.

Prior/Concomitant Medications and Treatments
13. Use of opioids or barbiturates >2 days per month in the 3 months prior to Screening.
14. Use of CBD or other types of cannabinoids in the 3 months prior to Screening and throughout the study.
15. 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 and at or above the shoulders at any time during the study.
16. Any monoclonal antibody CGRP inhibitor treatment (within or outside of a clinical study) within 6 months prior to Screening and throughout the study.
17. 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.
18. 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) during Screening and throughout the study.
19. 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.
20. History of inadequate response to 3 classes of medications (which have different mechanisms of action) prescribed for the prevention of migraine, excluding CGRP therapies.
21. History of hypersensitivity to human serum albumin, sucrose, or botulinum toxin type A or a positive test for botulinum toxin type A antibody.

Prior/Concurrent Clinical Study Experience
22. Participation in another interventional study within 6 months prior to Screening and throughout the study.
23. Female patients planning on becoming pregnant during the course of the study and/or lactating/breastfeeding.
24. Patient has donated or lost a significant volume (>450 mL) of blood or plasma within 30 days of screening.
25. Patient is an employee or family member of the investigator, study site personnel, PPD, or AEON.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/09/2024
Actual
Sample size
Target
Accrual to date
Final
797
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Grampians Health - Ballarat
Recruitment hospital [3] 0 0
Emeritus Research - Camberwell
Recruitment hospital [4] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
3350 - Ballarat
Recruitment postcode(s) [3] 0 0
3124 - Camberwell
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Nebraska
Country [15] 0 0
United States of America
State/province [15] 0 0
Nevada
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New Mexico
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
Tennessee
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Utah
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
Canada
State/province [25] 0 0
Alberta
Country [26] 0 0
Canada
State/province [26] 0 0
Nova Scotia
Country [27] 0 0
Canada
State/province [27] 0 0
Ontario
Country [28] 0 0
Canada
State/province [28] 0 0
Québec

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AEON Biopharma, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
PPD
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Richard B Lipton, MD
Address 0 0
Albert Einstein College of Medicine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual Participant Data collected during the trial, after deidentification may be shared following review of the clinical study report by the FDA review division and if a decision is made to publish the results in an publication outside posting the results in clinicaltrials.gov


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04845178