Clinical trial NCT05049057: Treatment of Acute PTH With a CGRP Receptor mAb in Military Service Members and Civilians With mTBI
Official title: Treatment of Acute Post-Traumatic Headache With Erenumab 140 mg, Military Service Members and Civilians With Mild TBI: A Randomized, Double Blind, Placebo Controlled, Multicenter 12-week Duration Study Followed by a 4-week Open-Label Safety Extension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Posttraumatic Headache
Mild Traumatic Brain Injury
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: Headache is recognized as one of the most common and disabling symptoms following head trauma. This study is designed to assess a calcitonin gene-related peptide (cGRP) monoclonal antibody (erenumab) for the preventive treatment of PTH based on the rationale that headache posttrauma is similar to migraine and is mediated by the activation of the trigeminal vascular system and subsequent release of cGRP. This study is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and efficacy of erenumab 140 mg for the treatment of PTH in military service members and civilians with mTBI at military treatment facilities across the United States.

Eligibility criteria: Inclusion Criteria:

* Male or female ≥18 and ≤50 years of age
* mTBI from any cause including impact, rotational acceleration, blast, or a combination, has occurred within the prior 7 days
* PTH has occurred within the prior 7 days
* Able to provide informed consent
* Likely to stay in the same geographical area for the duration of study
* Has a personal health care provider for standard of care PTH and TBI, including education, diagnostic procedures including neuroimaging and treatment, as deemed clinically indicated by the health care provider

Exclusion Criteria:

* Sustained a moderate or severe TBI, rather than mTBI, indicated with at least 1 of the following associated with head injury:

  1. abnormal structural imaging
  2. loss of consciousness for \>30 minutes
  3. alteration of consciousness/mental state for \>24 hours 3. post-traumatic amnesia for \>1 day
* Participants with ongoing chronic migraine or other chronic daily headache disorders at the time of injury

Primary outcomes:
measure: Monthly Headache Days
timeFrame: Week 8 to Week 12
Secondary outcomes:
measure: Monthly Headache Days
timeFrame: Week 0 to Week 12
measure: Monthly Headache Days
timeFrame: Week 0 to Week 4
measure: Monthly Headache Days
timeFrame: Week 0 to Week 8
measure: Adverse Events
timeFrame: Week 0 to Week 12
measure: Return to Full Duty
timeFrame: Week 0 to Week 12
measure: Concomitant Medications
timeFrame: Week 0 to Week 12
measure: Headache Days
timeFrame: Week 0 to Week 12
measure: HPFID Activity
timeFrame: Week 0 to Week 12
measure: HPFID Physical Impairment
timeFrame: Week 0 to Week 12
measure: HIT-6
timeFrame: Week 0 to Week 12
measure: PHQ-9
timeFrame: Week 0 to Week 12
measure: ISI
timeFrame: Week 0 to Week 12
Other outcomes:
measure: MSQ
timeFrame: Week 0 to Week 12
measure: ASC-12
timeFrame: Week 0 to Week 12
measure: ANAM
timeFrame: Week 0 to Week 12
measure: Function of Time
timeFrame: 0-24 hours, 24-72 hours, 72-144 hours
Locations:
city: Fort Bragg
country: United States
facility: Womack Army Medical Center - Fort Liberty
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh Concussion Research Laboratory
state: Pennsylvania
city: El Paso
country: United States
facility: William Beaumont Army Medical Center
state: Texas
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: David L Brody, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: