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Multidisciplinary Translational Approach to Investigate Mechanisms Predictors & Prevention of Persistent PTH

NCT04098250 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-10-23

Study results available
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Summary

This is a United States Department of Defense funded Focused Program study that aims to identify mechanisms and predictors for persistent of post-traumatic headache attributed to mild traumatic brain injury, and identify methods of preventing post-traumatic headache persistence.

The objective of the clinical trial component of the Focused Program is to determine whether intervention with erenumab is an effective treatment for PTH attributed to mTBI.

Conditions

  • Post-Traumatic Headache

Interventions

DRUG

Erenumab

a CGRP receptor monoclonal antibody

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • University of Arizona

    collaborator OTHER

  • Translational Genomics Research Institute

    collaborator OTHER

  • Arizona State University

    collaborator OTHER

  • Phoenix VA Health Care System

    collaborator FED

  • United States Department of Defense

    collaborator FED

  • Amgen

    collaborator INDUSTRY

  • Georgia Institute of Technology

    collaborator OTHER

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Todd Schwedt · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-04
Primary Completion
2024-01-10
Completion
2024-01-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT04098250 on ClinicalTrials.gov