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

Mild Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05049057
• Other study ID #: CNRM-CGRP-2020
• Status: Recruiting
• Phase: Phase 2
• Start date: July 19, 2022
• Est. completion date: May 19, 2027

Study information

• Verified date: February 2024
• Source: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Contact: Amy Guthrie, RN
• Phone: 202-924-2729
• Email: amy.guthrie.ctr[@]usuhs.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 404
• Est. completion date: May 19, 2027
• Est. primary completion date: May 19, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Headache
• Mild Traumatic Brain Injury
• Post-Traumatic Headache
• Posttraumatic Headache

Intervention

Drug:
• Erenumab 140 Mg/mL Subcutaneous Solution
Active erenumab delivered via subcutaneous injection.
• Placebo
Placebo delivered via subcutaneous injection.

Locations

Country	Name	City	State
United States	William Beaumont Army Medical Center	El Paso	Texas
United States	Womack Army Medical Center - Fort Liberty	Fort Bragg	North Carolina
United States	University of Pittsburgh Concussion Research Laboratory	Pittsburgh	Pennsylvania
United States	Madigan Army Medical Center	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Henry M. Jackson Foundation for the Advancement of Military Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MSQ	Change from baseline in quality of life scores as measured by the Migraine-specific Quality of Life Questionnaire	Week 0 to Week 12
Other	ASC-12	Change from baseline in frequency of allodynia symptoms as measured by the Allodynia Symptom Checklist	Week 0 to Week 12
Other	ANAM	Change from baseline in neuropsychological functions as assessed by the Automated Neuropsychological Assessment Metrics	Week 0 to Week 12
Other	Function of Time	Effect of erenumab compared to placebo as a function of time from mTBI to first dose of erenumab as measured by the daily headache diary	0-24 hours, 24-72 hours, 72-144 hours
Primary	Monthly Headache Days	Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary	Week 8 to Week 12
Secondary	Monthly Headache Days	Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary	Week 0 to Week 12
Secondary	Monthly Headache Days	Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary	Week 0 to Week 4
Secondary	Monthly Headache Days	Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary	Week 0 to Week 8
Secondary	Adverse Events	Number of adverse events reported in erenumab group compared to placebo	Week 0 to Week 12
Secondary	Return to Full Duty	Time to return to full activity as measured by the daily headache diary	Week 0 to Week 12
Secondary	Concomitant Medications	Monthly use of medications for acute headache treatment	Week 0 to Week 12
Secondary	Headache Days	Monthly headache days after early acute versus late acute administration of erenumab compared to placebo	Week 0 to Week 12
Secondary	HPFID Activity	Monthly impact on everyday activity scores as measured by the Headache Physical Function Impact Diary Domain 1	Week 0 to Week 12
Secondary	HPFID Physical Impairment	Monthly impact on physical impairment scores as measured by the Headache Physical Function Impact Diary Domain 2	Week 0 to Week 12
Secondary	HIT-6	Change from baseline in headache impact scores as measured by the Headache Impact Test	Week 0 to Week 12
Secondary	PHQ-9	Change from baseline in depressive symptoms after mTBI as measured by the self-report questionnaire, Patient Health Questionnaire-9, Total Score. Total scores range from a minimum of 0 to a maximum of 27, which are rated from minimal to severe levels of depression.	Week 0 to Week 12
Secondary	ISI	Change from baseline in insomnia scores as measured by the Insomnia Severity Index	Week 0 to Week 12