A Phase 2 interventional study of ABP-450 in Migraine, sponsored by AEON Biopharma, Inc.. Terminated at 55 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-20.
Sponsored by AEON Biopharma, Inc. · Phase 2, Interventional, and Prevention
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.
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 466 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →AEON Biopharma, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Failure to successfully complete the Study ABP-20001, including the following:
Medical Conditions:
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:
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
ABP-450 Low Dose - intramuscular injections into specified muscles.
Drug: ABP-450
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.
Also known as: prabotulinumtoxinA
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).
Time frame: 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.
Time frame: Baseline to Week 52 - End of Treatment Period
Percentage of Patients with Reduction in Mean Migraine Days (MMD)
Percentage of patients with a reduction from Baseline of ≥ 50 percent, ≥ 75 percent and 100% percent in average number of MMD throughout the study will be assessed by Treatment Group.
Time frame: Baseline to Week 52 - End of Study
Mean change in Monthly Migraine Days (MMD) requiring medications for acute treatment of migraine or headaches
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.
Time frame: Baseline to Week 52 - End of Study
Mean change in Headache Hours
Overall mean change from Baseline in headache (either moderate or severe) hours will be assessed by Treatment Group.
Time frame: Baseline to Week 52 - End of Study
Mean Change in Monthly Headache Days
Overall mean change from Baseline in monthly headache days will be assessed by Treatment Group.
Time frame: Baseline to Week 52 - End of Study
Suicidality by Columbia-Suicide Severity Rating Scale (C-SSRS)
Percentage of Participants with Suicidal Ideation and Behaviors will be assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) with the suicidal ideation on a 5-point scale, ranging from "wish to be dead" to "activesuidical ideatikon with specific plan and intert" and suicidal behaviors of a 4-point scale ranging from "preparatory acts or behavior" to "actual attempt" in lifetime, past 3 months, and since last visit. The higher total scores indicate more suicidal ideation and /or suicidal behavior.
Time frame: Baseline to Week 52 - End of Study
Development of Anti-Drug Antibodies (ADA) to ABP-450
Percentage of patients developing Anti-Drug Antibodies to ABP-450 antibodies (binding and if positive, neutralizing) will be assessed.
Time frame: Baseline to Week 52 - End of Study
Mean change of Migraine-Specific-Quality of Life (MSQ) Domains
The Mean Change in Migraine-Specific-Quality of Life (MSQ), a14-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.
Time frame: Baseline to Week 52 - End of Study
Mean Change in Patient Global Impression of Change (PGI-C) Score
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 with 1-item scale ranging from "much better"k to "much worse" with the higher score indicating worsening of symptoms will be assessed by Treatment Group.
Time frame: Baseline to Week 52 - End of Study
Mean Change in Patient Global Impression of Severity (PGI-S) Score
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 with 1-item scale ranging from "normal" to "severely ill" with the higher score indicaating greater severity in illness will be assessed by Treatment Group.
Time frame: Baseline to Week 52 - End of Study
Mean Change in Migraine Disability Assessment Score (MIDAS) Total Score
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).
Time frame: Baseline to Week 52 - End of Study
Percentage of Patients with Reduction in Migraine Physical Function Impact Diary (MPFID)
Percentage of patients with a reduction from Baseline in the impact on Migraine Physical Function Impact Diary (MPFID) will be assessed by Treatment Group with an 8-item scale ranging from "without difficulty" to "extremely difficult". The higher the score represents the highest level of impact.
Time frame: Baseline to Week 52 - End of Study
Percentage of Patients with Reduction in the Physical Impairment Domain Score of the Migraine Physical Function Impact Diary (MPFID)
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 with a 5-item scale ranging from "none of the time" to "all of the time" or :without any difficulty" to extremely difficult". The higher the score represents the highest level of impairment.
Time frame: Baseline to Week 52 - End of Study
Plan to share: No — 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 a publication outside posting the results in clinicaltrials.gov.
No publications or documents are linked to this record.
This study is terminated, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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