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Monoclonal Antibodies

Erenumab for Post-Traumatic Headache

Phase 2
Recruiting
Led By Todd Schwedt
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults 18-70 years of age
Have a diagnosis of acute PTH attributed to mild traumatic injury to the head as defined by the International Classification of Headache Disorders (ICHD-3)
Must not have
Episodic tension-type headache, migraine, or other headaches with at least 4 headache days/month on average over the 6 months prior to the mTBI resulting in PTH
Chronic headache (i.e., at least 15 headache days/month for more than 3 months) within 12 months prior to the mTBI that led to the current PTH, including PPTH, chronic migraine, medication overuse headache, new daily persistent headache, hemicrania continua, chronic tension-type headache
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9-12 weeks

Summary

This trial is looking into whether erenumab is an effective treatment for post-traumatic headache (PTH) caused by mild traumatic brain injury (mTBI).

Who is the study for?
Adults aged 18-70 with post-traumatic headache (PTH) due to mild traumatic brain injury, who have had PTH for 7-56 days and experienced an increase in moderate or severe headache days. Participants must be able to keep a headache diary and comply with study visits. Excluded are those with certain chronic headaches, recent use of specific treatments or preventive medications, unstable medical conditions, major psychiatric disorders, or women not using reliable contraception.
What is being tested?
The trial is testing Erenumab against a placebo to see if it can effectively treat persistent headaches that develop after a mild traumatic brain injury. Participants will be randomly assigned to receive either the medication or placebo as part of the study's efforts to understand and prevent long-term PTH.
What are the potential side effects?
Erenumab may cause side effects such as injection site reactions, constipation, muscle spasms or cramps. It could also lead to allergic reactions and changes in blood pressure. The full range of side effects is still being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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I have been diagnosed with acute post-traumatic headache due to a mild head injury.
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I've had 5 or more bad headache days recently, which is an increase from before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I've had an average of 4 headache days a month for the last 6 months.
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I've had chronic headaches for more than 3 months before my brain injury.
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I have been treated with a CGRP-targeted monoclonal antibody before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9-12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9-12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Moderate-to-severe headache day frequency
Secondary study objectives
Chronic headache
Headache Impact Test (HIT-6)
Responder rate
+1 more

Side effects data

From 2023 Phase 4 trial • 701 Patients • NCT04084314
35%
COVID-19
19%
Nasopharyngitis
15%
Constipation
9%
Fatigue
7%
Hypertension
6%
Depression
6%
Back pain
6%
Migraine
6%
Immunisation reaction
6%
Headache
5%
Nausea
5%
Arthralgia
4%
Alopecia
4%
Vertigo
4%
Pain in extremity
3%
Cough
3%
Pyrexia
3%
Cystitis
3%
Urinary tract infection
3%
Chills
3%
Tonsillitis
3%
Dizziness
3%
Oropharyngeal pain
3%
Pruritus
2%
Abdominal pain upper
2%
Procedural pain
2%
Diarrhoea
2%
Osteoarthritis
2%
Post vaccination fever
2%
Muscle spasms
1%
Appendicitis
1%
Intervertebral disc protrusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erenumab

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ErenumabExperimental Treatment1 Intervention
140 mg erenumab
Group II: PlaceboPlacebo Group1 Intervention
placebo comparator
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Erenumab
2016
Completed Phase 4
~7860

Find a Location

Who is running the clinical trial?

AmgenIndustry Sponsor
1,434 Previous Clinical Trials
1,395,724 Total Patients Enrolled
2 Trials studying Post-Traumatic Headache
364 Patients Enrolled for Post-Traumatic Headache
United States Department of DefenseFED
910 Previous Clinical Trials
333,619 Total Patients Enrolled
2 Trials studying Post-Traumatic Headache
789 Patients Enrolled for Post-Traumatic Headache
Arizona State UniversityOTHER
298 Previous Clinical Trials
107,825 Total Patients Enrolled
2 Trials studying Post-Traumatic Headache
524 Patients Enrolled for Post-Traumatic Headache
~17 spots leftby Aug 2025
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