NCT04845178

Investigation of Safety and Efficacy of ABP-450 for Migraine Prevention in Adults

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2 Study of ABP-450 (prabotulinumtoxinA) Purified Neurotoxin Complex for the Prevention of Migraine Headache

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 797 (actual)
• Sponsor: AEON Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	ABP-450	ABP-450 (prabotulinumtoxinA) contains a 900 kDa botulinum toxin type-A complex produced by the bacterium Clostridium botulinum.
DRUG	Placebo	0.9% sodium chloride, sterile, unpreserved, USP/PhEur

Timeline

• Start date: 2021-03-01
• Primary completion: 2024-06-19
• Completion: 2024-08-06
• First posted: 2021-04-14
• Last updated: 2024-09-04

Locations

62 sites across 3 countries: United States, Australia, Canada

Regulatory

• FDA-regulated drug study