Recruiting
Phase 2

CGRP Receptor mAb

Sponsor:

Henry M. Jackson Foundation for the Advancement of Military Medicine

Code:

NCT05049057

Conditions

Posttraumatic Headache

Mild Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Erenumab 140 Mg/mL Subcutaneous Solution

Placebo

Study Details

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).

Conditions

Posttraumatic Headache

Mild Traumatic Brain Injury

Study ID

NCT05049057

Start date

Jul 19, 2022

Status verified date

Feb, 2024

Completion date

May 19, 2027

Anticipated

Primary completion date

May 19, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

404 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active Drug

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

placebo comparator: Placebo

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

Interventions

Erenumab 140 Mg/mL Subcutaneous Solution

Active erenumab delivered via subcutaneous injection.

Placebo

Placebo delivered via subcutaneous injection.

Primary outcome measure

  • Monthly Headache Days [ Time Frame: Week 8 to Week 12 ]

Central Contacts and Locations

Central contacts

Amy Guthrie, RN

202-924-2729amy.guthrie.ctr@usuhs.edu

Locations

Womack Army Medical Center - Fort Liberty

Recruiting

Fort Bragg, North Carolina, United States, 28310

Contacts

Jennifer Robles, RN

240-749-1042jennifer.robles.ctr@usuhs.edu

Alexandra Fraiser

240-749-4550alexandra.fraiser.ctr@usuhs.edu

Principal Investigator:

CDR Katherine Demers

William Beaumont Army Medical Center

Recruiting

El Paso, Texas, United States, 79918

Contacts

Cecilia Valdovinos, NP

cecilia.valdovinos.ctr@usuhs.edu

Principal Investigator:

Sean Sebesta, MD

More Information

Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Last update posted

Feb 22, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Henry M. Jackson Foundation for the Advancement of Military Medicine on 2024-02-22.