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

NCT04845178 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 797

Last updated 2024-09-04

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • AEON Biopharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard B Lipton, MD · Albert Einstein College of Medicine

  • Stewart J Tepper, MD · Dartmouth-Hitchcock Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2024-06-19
Completion
2024-08-06
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04845178 on ClinicalTrials.gov