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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
Must not have
Sustained a moderate or severe TBI, rather than mTBI, indicated with at least 1 of the following associated with head injury: abnormal structural imaging, loss of consciousness for >30 minutes, alteration of consciousness/mental state for >24 hours, post-traumatic amnesia for >1 day
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-24 hours, 24-72 hours, 72-144 hours

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.
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.
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.
Select...
I am between 18 and 50 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I had a serious head injury with symptoms like unconsciousness or memory loss.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Adverse Events
Concomitant Medications
HIT-6
+7 more
Other study objectives
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
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: 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.

Find a Location

Who is running the clinical trial?

Henry M. Jackson Foundation for the Advancement of Military MedicineLead Sponsor
98 Previous Clinical Trials
93,351 Total Patients Enrolled
2 Trials studying Headache
100 Patients Enrolled for 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
~149 spots leftby May 2026
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