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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9-12 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am between 18 and 70 years old.

Select...

I have been diagnosed with acute post-traumatic headache due to a mild head injury.

Select...

I've had 5 or more bad headache days recently, which is an increase from before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9-12 weeks

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

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

Primary outcome measures

Moderate-to-severe headache day frequency

Secondary outcome measures

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

Fatigue

Hypertension

Back pain

Immunisation reaction

Headache

Migraine

Depression

Nausea

Arthralgia

Vertigo

Alopecia

Pain in extremity

Tonsillitis

Cystitis

Urinary tract infection

Dizziness

Oropharyngeal pain

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: 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

AmgenIndustry Sponsor

1,371 Previous Clinical Trials

1,377,994 Total Patients Enrolled

2 Trials studying Post-Traumatic Headache

364 Patients Enrolled for Post-Traumatic Headache

United States Department of DefenseFED

864 Previous Clinical Trials

327,487 Total Patients Enrolled

2 Trials studying Post-Traumatic Headache

789 Patients Enrolled for Post-Traumatic Headache

Arizona State UniversityOTHER

283 Previous Clinical Trials

109,402 Total Patients Enrolled

2 Trials studying Post-Traumatic Headache

524 Patients Enrolled for Post-Traumatic Headache

Frequently Asked Questions

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

Is there still room for participants in this investigation?

"Correct. The clinical trial registry confirms that recruitment for this medical study, which was first shared on April 1st 2021, is ongoing. Approximately 112 patients need to be enrolled from 3 distinct sites."

Answered by AI

Does this research endeavor represent a pioneering effort for its field?

"Currently, there are 18 trials in progress for erenumab that span 32 countries and 178 cities. The first clinical trial of this drug was conducted by Amgen back in 2019 with 456 participants; since then, a total of 18334 studies have been completed, achieving Phase 3 approval status."

Answered by AI

How many participants are currently enrolled in this experiment?

"Yes, according to clinicaltrials.gov this trial still welcomes new participants. It was initially published on April 1st 2021 and last modified on March 11th 2022. A total of 112 patients will be enrolled from 3 distinct sites."

Answered by AI

Is it possible for me to join this research endeavor?

"To qualify for this medical research, potential participants must have cervicogenic headache and be aged 18-70. A total of 112 volunteers are being enrolled in the trial."

Answered by AI

Could you illustrate the history of research regarding Erenumab?

"Presently, 18 clinical trials examining Erenumab are in motion with 3 of those reaching the third phase. While there is a concentrated focus on Scottsdale, Arizona for this investigation, 548 different medical centres across the nation are taking part."

Answered by AI

Has the FDA accepted Erenumab for therapeutic use?

"There is preliminary evidence indicating the safety of Erenumab, and thus it earned a score of 2. However there has yet to be any definitive proof that this drug is effective in humans."

Answered by AI

Is enrollment for this research open to minors?

"This clinical study only accepts patients aged between 18 and 70. There are 21 studies specially tailored to those under the age of majority, while 101 trials focus on individuals over 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Multidisciplinary Translational Approach to Investigate Mechanisms Predictors & Prevention of Persistent PTH

Todd J. Schwedt 2021. "Multidisciplinary Translational Approach to Investigate Mechanisms Predictors & Prevention of Persistent PTH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04098250.

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