NCT05049057 · Henry M. Jackson Foundation for the Advancement of Military Medicine
Treatment of Acute PTH With a CGRP Receptor mAb in Military Service Members and Civilians With mTBI
What this study is about
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).
View original scientific description
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).
Interventions
DRUG
Erenumab 140 Mg/mL Subcutaneous Solution
Active erenumab delivered via subcutaneous injection.
DRUG
Placebo
Placebo delivered via subcutaneous injection.
Primary outcome measures
Monthly Headache Days
Time frame: Week 8 to Week 12
Effect of erenumab versus placebo on monthly headache days as measured by the daily headache diary
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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
Exclusion criteria
- Sustained a moderate or severe TBI, rather than mTBI, indicated with at least 1 of the following associated with head injury: 1. abnormal structural imaging 2. loss of consciousness for \>30 minutes 3. 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
Where
- Fort Bragg, North Carolina
- Pittsburgh, Pennsylvania
- El Paso, Texas
- Tacoma, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 22, 2024 · Source of record for eligibility and locations