NCT04098250

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

A Multidisciplinary Translational Approach to Investigate the Mechanisms, Predictors, and Prevention of Persistent Post-Traumatic Headache

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The human studies component of this Focused Program includes clinical phenotyping, neurophysiology, molecular and genetic biomarker discovery, brain imaging, and a clinical trial.These data will be utilized to characterize post-traumatic headache and build univariate and multivariate predictive models for post-traumatic headache persistence and for the response to post-traumatic headache treatment. These studies are described in more detail within a separate clinicaltrials.gov record. The clinical trial is a double-blind, randomized, placebo-controlled investigation of erenumab for the treatment of post-traumatic headache. Participants will be randomized when PTH has been present for 35-56 days. Follow-up questionnaires, headache diary data, pain threshold results, and brain imaging data will be collected longitudinally during the clinical trial to assess for changes over time and associations of such changes with post-traumatic headache treatment outcomes. Due to slow enrollment, the study was later changed to open label since the estimated total enrollment would be inadequate for making comparisons between the placebo and erenumab groups.

Conditions

• Post-Traumatic Headache

Interventions

Type	Name	Description
DRUG	Erenumab	a CGRP receptor monoclonal antibody
OTHER	Placebo	Placebo

Timeline

• Start date: 2021-01-04
• Primary completion: 2024-01-10
• Completion: 2024-01-10
• First posted: 2019-09-23
• Last updated: 2025-10-23
• Results posted: 2025-10-23

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study