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New treatment option for Posttraumatic Headache
Official title Treatment of Acute PTH With a CGRP Receptor mAb in Military Service Members and Civilians With mTBI
ClinicalTrials.gov ID: NCT05049057
What this study is testing
What is Erenumab 140 Mg/mL Subcutaneous Solution?
Erenumab 140 Mg/mL Subcutaneous Solution is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for posttraumatic headache.
Also referred to as Aimovig.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Fort Bragg, North Carolina, United States
- Pittsburgh, Pennsylvania, United States
- El Paso, Texas, United States
- Tacoma, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fort Bragg, North Carolina, United States; Pittsburgh, Pennsylvania, United States; El Paso, Texas, United States; Tacoma, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.