A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2 Study of ABP-450 (prabotulinumtoxinA) Purified Neurotoxin Complex for the Prevention of Migraine Headache
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Migraine
- Sponsor
- AEON Biopharma, Inc.
- Enrollment
- 797
- Primary Endpoint
- Change in Monthly Migraine Days
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •Male or female patients 18 years or older of age (no upper age limit) at the time of signing the informed consent.
- •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.
- •Age of the patient at the time of migraine onset \<50 years.
- •History of, on average ≥6 migraine or probable migraine days per month in the 3 months prior to Screening.
- •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.
- •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.
- •A WOCBP must have a negative pregnancy test at Screening.
- •Patient is able to read, understand, and complete the eDiary.
- •Patient is willing and able to adhere to the study assessments, visit schedules, and prohibitions, as described in this protocol.
Exclusion Criteria
- •Medical Conditions
- •History of migraine accompanied by diplopia or decreased level of consciousness, or retinal migraine.
- •Current diagnosis of chronic tension-type headache, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or cranial neuropathy.
- •Confounding and clinically significant pain syndromes (eg, fibromyalgia, chronic low back pain, complex regional pain syndromes) as evaluated by the investigator.
- •Diagnosis of myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease that might interfere with the study.
- •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.
- •History of addiction, including alcohol or drugs of abuse, within 6 months prior to Screening.
- •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.
- •Any infection or clinically significant skin problem in any of the injection sites.
Outcomes
Primary Outcomes
Change in Monthly Migraine Days
Time Frame: Baseline to Weeks 21 to 24 Treatment period.
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.
Incidence of Treatment Emergent Adverse Events
Time Frame: Baseline to Week 28 - End of Study.
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).
Secondary Outcomes
- Mean change in Monthly Migraine Days (MMD)(Baseline to Week 28 - End of Study.)
- Mean change in Headache Hours(Baseline to Week 28 - End of Study.)
- Mean Change in Monthly Headache Days(Baseline to Week 28 - End of Study.)
- Percentage of Patients with Reduction in Mean Migraine Days (MMD)(Baseline to Week 28 - End of Study.)
- Mean change in Monthly Migraine Days (MMD) requiring medications for acute treatment of migraine or headaches(Baseline to Week 28 - End of Study.)
- Mean change of Migraine-Specific-Quality of Life (MSQ) Domains(Baseline to Week 28 - End of Study.)
- Percentage of Patients with Reduction in Migraine Physical Function Impact Diary (MPFID)(Baseline to Week 28 - End of Study.)
- Suicidality by Columbia-Suicide Severity Rating Scale (C-SSRS)(Baseline to Week 28 - End of Study.)
- Development of Anti-Drug Antibodies (ADA) to ABP-450(Baseline to Week 28 - End of Study.)