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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
466
ABP-450 (prabotulinumtoxinA) contains a 900 kDa botulinum toxin type-A complex produced by the bacterium Clostridium botulinum.
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
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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