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Monoclonal Antibodies

Erenumab for Post-Traumatic Headache

Phase 2

Recruiting

Led By David L Brody, MD, PhD

Research Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

mTBI from any cause including impact, rotational acceleration, blast, or a combination, has occurred within the prior 7 days

Male or female ≥18 and ≤50 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-24 hours, 24-72 hours, 72-144 hours

Awards & highlights

Study Summary

This trial will compare erenumab to placebo to see if it is effective and safe for treating people with acute post-traumatic headaches who have mild traumatic brain injuries.

Who is the study for?

This trial is for military and civilian adults aged 18-50 who've had a mild traumatic brain injury (mTBI) and headache within the past week. They must have a healthcare provider, be stable geographically during the study, and able to consent. Those with moderate/severe TBI or chronic headaches prior to injury cannot join.Check my eligibility

What is being tested?

The trial tests Erenumab, an injectable medication against placebo, in treating acute posttraumatic headache after mTBI. Participants will randomly receive either Erenumab or a placebo to compare effectiveness and safety.See study design

What are the potential side effects?

Erenumab may cause reactions at the injection site, constipation, muscle spasms or cramps. It's also possible but less common to experience more serious side effects like allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had a mild traumatic brain injury within the last week.

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I am between 18 and 50 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-24 hours, 24-72 hours, 72-144 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-24 hours, 24-72 hours, 72-144 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-24 hours, 24-72 hours, 72-144 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Adverse Events

Concomitant Medications

HIT-6

+7 more

Other outcome measures

ANAM

ASC-12

Function of Time

+1 more

Side effects data

From 2023 Phase 4 trial • 701 Patients • NCT04084314

35%

COVID-19

19%

Nasopharyngitis

15%

Constipation

Fatigue

Hypertension

Depression

Back pain

Immunisation reaction

Headache

Migraine

Nausea

Arthralgia

Vertigo

Alopecia

Pain in extremity

Tonsillitis

Cystitis

Urinary tract infection

Oropharyngeal pain

Dizziness

Chills

Pruritus

Pyrexia

Cough

Diarrhoea

Post vaccination fever

Abdominal pain upper

Muscle spasms

Osteoarthritis

Procedural pain

Appendicitis

Intervertebral disc protrusion

100%

80%

60%

40%

20%

Study treatment Arm

Erenumab

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active DrugExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Henry M. Jackson Foundation for the Advancement of Military MedicineLead Sponsor

92 Previous Clinical Trials

92,485 Total Patients Enrolled

1 Trials studying Headache

David L Brody, MD, PhDPrincipal InvestigatorUniformed Services University of the Health Sciences

3 Previous Clinical Trials

333 Total Patients Enrolled

Media Library

Erenumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05049057 — Phase 2

Headache Research Study Groups: Active Drug, Placebo

Headache Clinical Trial 2023: Erenumab Highlights & Side Effects. Trial Name: NCT05049057 — Phase 2

Erenumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05049057 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity for me to be included in this medical trial?

"To qualify for this study, potential participants must be between 18 and 50 years old with a diagnosis of post-traumatic headaches. As such, 404 candidates are being accepted into the trial."

Answered by AI

Has the FDA granted authorization to Erenumab 140 Mg/mL Subcutaneous Solution?

"Erenumab 140 Mg/mL Subcutaneous Solution was evaluated on a scale from 1 to 3, and it received a score of 2 as there is prior evidence supporting safety but no data demonstrating its efficacy."

Answered by AI

Does the patient recruitment for this trial accept individuals of 40 years and over?

"As specified by the inclusion criteria, participants must be aged 18 or above and no older than 50 to qualify for enrollment in this trial."

Answered by AI

Is this clinical trial pioneering for its field?

"Currently, Amgen's Erenumab 140 Mg/mL Subcutaneous Solution is the subject of 18 active clinical trials in 179 cities and 32 countries. It was first tested in 2019 with 456 patients enrolled for Phase 3 drug approval; since then a total of 18338 studies have been conducted to date."

Answered by AI

Are there opportunities for participants to join this experiment?

"That is accurate. Per the information present on clinicaltrials.gov, this medical trial opened its recruitment period on July 19th 2022 and has since been updated to reflect new details. There are 404 participants needed from 3 locations across the country."

Answered by AI

What is the current number of participants engaged in this clinical trial?

"Affirmative. The clinicaltrials.gov website displays that this medical trial, which initially went live on July 19th 2022, is actively recruiting volunteers. 404 participants are required from 3 distinct study sites."

Answered by AI

Are there any prior investigations involving Erenumab 140 Mg/mL Subcutaneous Solution?

"Currently, 18 clinical trials are running for Erenumab 140 Mg/mL Subcutaneous Solution with 3 of those being in the final phase. The majority of these studies can be found in Rochester, Minnesota but there is a total of 549 testing sites around the world."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Treatment of Acute PTH With a CGRP Receptor mAb in Military Service Members and Civilians With mTBI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05049057.

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