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

NCT04098250 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 19-003200
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 5

Brief Summary

This is a United States Department of Defense funded Focused Program study that aims to identify mechanisms and predictors for persistent of post-traumatic headache attributed to mild traumatic brain injury, and identify methods of preventing post-traumatic headache persistence. The objective of the clinical trial component of the Focused Program is to determine whether intervention with erenumab is an effective treatment for PTH attributed to mTBI.

Conditions

Post-Traumatic Headache

Keywords

headache; post-traumatic headache

Outcome Measures

Primary Outcomes (1)

• Change in the Number of Days Experiencing Moderate-to-Severe Headaches

  The number of days where subjects experienced moderate-to-severe headaches. This was measured at baseline, 9, 10, 11 and 12 weeks after administration of first dose of erenumab 140 mg or placebo. The change from baseline to week 12 is reported.

  Baseline, 9, 10, 11 and 12 Weeks, change from baseline to week 12 reported

Secondary Outcomes (4)

• Responder Rate

  Baseline, 9, 10, 11 and 12 Weeks, change from baseline to week 12 reported

• Chronic Headache

  Baseline, 9, 10, 11 and 12 Weeks, change from baseline to week 12 reported

• Change in the Headache Impact Test (HIT-6)

  Baseline, 9, 10, 11 and 12 Weeks, change from baseline to week 12 reported

• Change in the Number of Days Where Acute Treatment Was Administered to Relieve a Headache

  Baseline, 9, 10, 11 and 12 Weeks, change from baseline to week 12 reported

Study Arms (2)

Erenumab

EXPERIMENTAL

140 mg erenumab

Drug: Erenumab

Placebo

PLACEBO COMPARATOR

placebo comparator

Other: Placebo

Interventions

Erenumab DRUG

a CGRP receptor monoclonal antibody

Also known as: Aimovig

Erenumab

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• PTH onset 7-56 days prior to the time of enrollment
• Adults 18-70 years of age
• Willing to be randomized to either of the two clinical trial treatment arms
• Willing to maintain a headache diary
• Willing and able to return for follow-up visits
• or more moderate or severe headache days during the 4-week run-in phase and an increase of at least 2 moderate to severe headache days compared to pre-TBI and at least a 30% increase
• At least 80% compliant with diary keeping during the 4-week run-in phase (i.e., provides data on at least 80% of days)

You may not qualify if:

• 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
• Diminished decision-making capacity that in the investigator's opinion would interfere with the person's ability to provide informed consent and complete study procedures
• Started or changed dose of a headache preventive medication within the 3 months prior to screening
• Use of onabotulinumtoxinA in the head, neck or face region within 6 months of screening
• During the 6 months before screening, use of opioids or barbiturates on an average of at least 4 days per month
• Subjects who underwent an intervention or used a device (e.g., nerve blocks, transcranial magnetic stimulation, vagal nerve stimulation, or electrical trigeminal nerve stimulation) for headache within 3 months of screening
• History of major psychiatric disorder such as schizophrenia and bipolar disorder
• History or evidence of any unstable or clinically significant medical condition, that in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
• History of positive neuroimaging findings that indicate a moderate or severe TBI
• Metal implants
• Aneurysm clips
• Severe claustrophobia
• Implanted electronic device
• Insulin or infusion pump
• Cochlear/otologic/ear implant

Sponsors & Collaborators

• Mayo Clinic: lead
• University of Arizona: collaborator
• Translational Genomics Research Institute: collaborator
• Arizona State University: collaborator
• Phoenix VA Health Care System: collaborator
• United States Department of Defense: collaborator
• Amgen: collaborator
• Georgia Institute of Technology: collaborator

Study Sites (5)

Phoenix VA Health Care System

Phoenix, Arizona, 85012, United States

Location

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

MeSH Terms

Conditions

Post-Traumatic Headache; Headache

Interventions

erenumab

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Todd Schwedt, M.D.
• Organization: Mayo Clinic

Schwedt.Todd@mayo.edu

480-301-9721

Study Officials

• Todd Schwedt

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 1:1 randomization to erenumab or placebo

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 23, 2019
• Study Start: January 4, 2021
• Primary Completion: January 10, 2024
• Study Completion: January 10, 2024
• Last Updated: October 23, 2025
• Results First Posted: October 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)