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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05016661




Registration number
NCT05016661
Ethics application status
Date submitted
17/08/2021
Date registered
23/08/2021
Date last updated
12/12/2023

Titles & IDs
Public title
Extension Study of ABP-20001 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 for Migraine Prevention
Scientific title
A Randomized, Multicenter, Dose-Blinded, Phase 2 Extension Study of ABP-450 (prabotulinumtoxinA) Purified Neurotoxin Complex for the Prevention of Migraine Headache
Secondary ID [1] 0 0
ABP-20002
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

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


Treatment: Drugs: ABP-450
ABP-450 (prabotulinumtoxinA) contains a 900 kDa botulinum toxin type-A complex produced by the bacterium Clostridium botulinum.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment Emergent Adverse Events
Timepoint [1] 0 0
Baseline to Week 52 - End of Study
Primary outcome [2] 0 0
Change in Monthly Migraine Days
Timepoint [2] 0 0
Baseline to Week 52 - End of Treatment Period
Secondary outcome [1] 0 0
Percentage of Patients with Reduction in Mean Migraine Days (MMD)
Timepoint [1] 0 0
Baseline to Week 52 - End of Study
Secondary outcome [2] 0 0
Mean change in Monthly Migraine Days (MMD) requiring medications for acute treatment of migraine or headaches
Timepoint [2] 0 0
Baseline to Week 52 - End of Study
Secondary outcome [3] 0 0
Mean change in Headache Hours
Timepoint [3] 0 0
Baseline to Week 52 - End of Study
Secondary outcome [4] 0 0
Mean Change in Monthly Headache Days
Timepoint [4] 0 0
Baseline to Week 52 - End of Study
Secondary outcome [5] 0 0
Suicidality by Columbia-Suicide Severity Rating Scale (C-SSRS)
Timepoint [5] 0 0
Baseline to Week 52 - End of Study
Secondary outcome [6] 0 0
Development of Anti-Drug Antibodies (ADA) to ABP-450
Timepoint [6] 0 0
Baseline to Week 52 - 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. 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

23. Participation in another interventional study since initiating ABP-20001 study
treatment. Other

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.

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
4/09/2025
Actual
Sample size
Target
666
Accrual to date
Final
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 Mexico
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
Canada
State/province [24] 0 0
Alberta
Country [25] 0 0
Canada
State/province [25] 0 0
Nova Scotia
Country [26] 0 0
Canada
State/province [26] 0 0
Ontario
Country [27] 0 0
Canada
State/province [27] 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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05016661
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05016661