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

Henry M. Jackson Foundation for the Advancement of Military Medicine

Status and phase: Enrolling; Phase 2

Conditions: Mild Traumatic Brain Injury; Posttraumatic Headache

Treatments: Drug: Erenumab 140 Mg/mL Subcutaneous Solution; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05049057

CNRM-CGRP-2020

Details and patient eligibility

About

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).

Full 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.

Enrollment: 404 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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404 participants in 2 patient groups, including a placebo group

Active Drug

Experimental group

Description:

Erenumab administered once monthly via two 70-mg subcutaneous injections at 3 time points over a 12-week period.

Treatment:

Drug: Erenumab 140 Mg/mL Subcutaneous Solution

Placebo

Placebo Comparator group

Description:

Placebo administered once monthly via two subcutaneous injections at 3 time points over a 12-week period.

Treatment:

Drug: Placebo