Posttraumatic HeadachePhase 2NCT05049057
Treatment of Acute PTH With a CGRP Receptor mAb in Military Service Members and Civilians With mTBI
A Phase 2 study testing Erenumab 140 Mg/mL Subcutaneous Solution in people with Posttraumatic Headache and Mild Traumatic Brain Injury, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 4 sites in United States.
Trial summary
This study aims to assess the effect and safety of erenumab compared to placebo for the treatment of acute posttraumatic headache (PTH) in military service members and civilians with mild traumatic brain injury (mTBI). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Posttraumatic Headache, Mild Traumatic Brain Injury
- What is being tested?
- Erenumab 140 Mg/mL Subcutaneous Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 404 participants
- Where
- 4 sitesUnited States
- Study dates
- 19 Jul 2022to 19 May 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female ≥18 and ≤50 years of age
- mTBI from any cause including impact, rotational acceleration, blast, or a combination, has occurred within the prior 7 days
- PTH has occurred within the prior 7 days
- Able to provide informed consent
- Likely to stay in the same geographical area for the duration of study
- Has a personal health care provider for standard of care PTH and TBI, including education, diagnostic procedures including neuroimaging and treatment, as deemed clinically indicated by the health care provider
Who cannot join
- 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 3. post-traumatic amnesia for >1 day
- Participants with ongoing chronic migraine or other chronic daily headache disorders at the time of injury
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
William Beaumont Army Medical Center
El Paso, Texas, 79918
Cecilia Valdovinos, NP, cecilia.valdovinos.ctr@usuhs.edu
Sean Sebesta, MD
- Recruiting
Womack Army Medical Center - Fort Liberty
Fort Bragg, North Carolina, 28310
Jennifer Robles, RN, 240-749-1042, jennifer.robles.ctr@usuhs.edu
Alexandra Fraiser, 240-749-4550, alexandra.fraiser.ctr@usuhs.edu
- Not yet recruiting
University of Pittsburgh Concussion Research Laboratory
Pittsburgh, Pennsylvania, 15203
Courtney Perry, 412-904-1298, cap236@pitt.edu
Anthony Kontos, MD
- Not yet recruiting
Madigan Army Medical Center
Tacoma, Washington, 98431
Janel Cuevas, 240-890-6518, janel.cuevas.ctr@usuhs.edu
Melissa Belle, NP
About this study
Official title: Treatment of Acute Post-Traumatic Headache With Erenumab 140 mg, Military Service Members and Civilians With Mild TBI: A Randomized, Double Blind, Placebo Controlled, Multicenter 12-week Duration Study Followed by a 4-week Open-Label Safety Extension
This study aims to assess the effect and safety of erenumab compared to placebo for the treatment of acute posttraumatic headache (PTH) in military service members and civilians with mild traumatic brain injury (mTBI).
Read the detailed description
Headache is recognized as one of the most common and disabling symptoms following head trauma. This study is designed to assess a calcitonin gene-related peptide (cGRP) monoclonal antibody (erenumab) for the preventive treatment of PTH based on the rationale that headache posttrauma is similar to migraine and is mediated by the activation of the trigeminal vascular system and subsequent release of cGRP. This study is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and efficacy of erenumab 140 mg for the treatment of PTH in military service members and civilians with mTBI at military treatment facilities across the United States.
- Being tested
- Erenumab 140 Mg/mL Subcutaneous Solution, Placebo
- Medical subject headings
- Post-Traumatic Headache, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erenumab 140 Mg/mL Subcutaneous SolutionDrug
Also called Aimovig
Active erenumab delivered via subcutaneous injection.
PlaceboDrug
Placebo delivered via subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Active Drug | Experimental | Erenumab administered once monthly via two 70-mg subcutaneous injections at 3 time points over a 12-week period. Receives: Drug: Erenumab 140 Mg/mL Subcutaneous Solution |
| Placebo | Placebo comparator | Placebo administered once monthly via two subcutaneous injections at 3 time points over a 12-week period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monthly Headache Days
Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
Measured: Week 8 to Week 12
Secondary outcomes (12)
Monthly Headache Days
Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
Measured: Week 0 to Week 12
Monthly Headache Days
Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
Measured: Week 0 to Week 4
Monthly Headache Days
Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
Measured: Week 0 to Week 8
Adverse Events
Number of adverse events reported in erenumab group compared to placebo
Measured: Week 0 to Week 12
Return to Full Duty
Time to return to full activity as measured by the daily headache diary
Measured: Week 0 to Week 12
Concomitant Medications
Monthly use of medications for acute headache treatment
Measured: Week 0 to Week 12
Headache Days
Monthly headache days after early acute versus late acute administration of erenumab compared to placebo
Measured: Week 0 to Week 12
HPFID Activity
Monthly impact on everyday activity scores as measured by the Headache Physical Function Impact Diary Domain 1
Measured: Week 0 to Week 12
HPFID Physical Impairment
Monthly impact on physical impairment scores as measured by the Headache Physical Function Impact Diary Domain 2
Measured: Week 0 to Week 12
HIT-6
Change from baseline in headache impact scores as measured by the Headache Impact Test
Measured: Week 0 to Week 12
PHQ-9
Change from baseline in depressive symptoms after mTBI as measured by the self-report questionnaire, Patient Health Questionnaire-9, Total Score. Total scores range from a minimum of 0 to a maximum of 27, which are rated from minimal to severe levels of depression.
Measured: Week 0 to Week 12
ISI
Change from baseline in insomnia scores as measured by the Insomnia Severity Index
Measured: Week 0 to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start19 Jul 2022
- Primary completion19 May 2026 (estimated)
- Study completion19 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 404 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David L Brody, MD, PhD, Principal investigator, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049057
- Sponsor's protocol ID
- CNRM-CGRP-2020
- Status last verified
- Feb 2024
- First submitted
- 26 Jul 2021
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Identifier-free participant data sets will be shared with the Uniformed Services University Center for Neuroscience and Regenerative Medicine Data Repository. Identifier-free data sets may also be shared with the Federal Interagency Traumatic Brain Injury Research (FITBIR) Data Repository