Treatment of Acute PTH With a CGRP Receptor mAb in Military Service Members and Civilians With mTBI

NCT05049057 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 404

Last updated 2024-02-22

No results posted yet for this study

Summary

This study aims to assess the effect and safety of erenumab compared to placebo for the treatment of acute posttraumatic headache (PTH) in military service members and civilians with mild traumatic brain injury (mTBI).

Conditions

  • Posttraumatic Headache
  • Mild Traumatic Brain Injury

Interventions

DRUG

Erenumab 140 Mg/mL Subcutaneous Solution

Active erenumab delivered via subcutaneous injection.

DRUG

Placebo

Placebo delivered via subcutaneous injection.

Sponsors & Collaborators

  • Henry M. Jackson Foundation for the Advancement of Military Medicine

    lead OTHER

Principal Investigators

  • David L Brody, MD, PhD · Uniformed Services University of the Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-07-19
Primary Completion
2026-05-19
Completion
2027-05-19

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT05049057 on ClinicalTrials.gov