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 765 patients across approximately 64 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.
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 765 patients across approximately 64 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
797
Change in Monthly Migraine Days
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.
Time frame: Baseline to Weeks 21 to 24 Treatment period.
Incidence of Treatment Emergent Adverse Events
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).
Time frame: Baseline to Week 28 - End of Study.
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 will be assessed by Treatment Group.
Time frame: Baseline to Week 28 - End of Study.
Mean change in Monthly Migraine Days (MMD)
Overall mean change from Baseline in the number of MMD will be assessed by Treatment Group.
Time frame: Baseline to Week 28 - 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 28 - 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 28 - End of Study.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
MDFirst Research
Chandler, Arizona, United States
Elite Clinical Studies, LLC
Phoenix, Arizona, United States
Arizona Neuroscience Research
Phoenix, Arizona, United States
Clinical Research Consortium Arizona
Tempe, Arizona, United States
Axiom Research LLC
Colton, California, United States
Velocity Research San Diego
La Mesa, California, United States
Collaborative Neuroscience Research
Long Beach, California, United States
Los Angeles Headache Center
Los Angeles, California, United States
Anderson Clinical Research
Redlands, California, United States
Artemis Institute For Clinical Research LLC - San Diego - ClinEdge - PPDS
San Diego, California, United States
...and 52 more locations
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 28 - End of Study.
Mean change of Migraine-Specific-Quality of Life (MSQ) Domains
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.
Time frame: Baseline to Week 28 - 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.
Time frame: Baseline to Week 28 - End of Study.
Suicidality by Columbia-Suicide Severity Rating Scale (C-SSRS)
Percentage of patients with Suicidal Ideation and Behaviors will be assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS).
Time frame: Baseline to Week 28 - 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 28 - End of Study.