Investigation of Safety and Efficacy of ABP-450 for Migraine Prevention in Adults
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Migraine
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Approximately 690 patients will be randomized in a 1:1:1 ratio and receive 1 of the following 3 treatments: ABP-450 Low Dose, ABP-450 High Dose, or placebo via intramuscular injection into pre-specified areas of the head and neck.Masking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: The investigator, study nurse/other study personnel, and patients will be blinded to the treatment group. An appropriately trained person will reconstitute investigational product, fill masked-labeled syringes and provide them to the investigator, but will not perform any assessments with the patient.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 690 patients across approximately 60 sites in the United States, Canada and Australia. Study subjects will be divided evenly...
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 690 patients across approximately 60 sites in the United States, Canada and Australia. Study subjects will be divided evenly across a low dose group receiving 150 units of ABP-450, a high dose group receiving 195 units of ABP-450, 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.
Tracking Information
- NCT #
- NCT04845178
- Collaborators
- PPD
- Investigators
- Principal Investigator: Richard B Lipton, MD Albert Einstein College of Medicine Principal Investigator: Stewart J Tepper, MD Dartmouth-Hitchcock Medical Center
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