Clinical Trial Details
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NCT02965027 : Prazosin for Post-Concussive Headaches
PhasePhase 4
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Male and female Active-duty Servicemembers or Veterans aged 18 or older who were in
military service at any time from October 7, 2001 to the present who are in good
general health.

- History of blast and/or impact head trauma mTBI meeting Defense and Veterans Brain
Injury Center (DVBIC) mTBI criteria, which define mTBI as an injury to the head
causing at least one of the following: alteration in consciousness (for up to 24
hours after the injury), loss of consciousness 0-30 minutes, and/or post-traumatic
amnesia up to 1 day post-injury. If available, the Glasgow Coma Scale score must be
13-15, and head imaging findings (if imaging was performed) must be negative.

- Frequent headaches (HAs) that started within 30 days after a head injury. The HAs
either 1) must last 4 or more hours a day and reach a moderate to severe intensity at
any point during the headache, or 2) may be of any severity or duration if the
participant takes a triptan or ergotamine. HAs meeting these criteria must have been
present on average at least 8 days per 4-week period, starting within 30 days after
head injury and occurring by self-report for at least 3 months prior to the Initial
Screening Visit. The 4-week HA frequency/severity criteria must be confirmed during
the Preliminary Screening Period.

- Women of childbearing potential must agree to abstain from sexual relations that
could result in pregnancy or use an effective method of birth control acceptable to
both participant and the clinician prescriber during the study. Men are not required
to use contraception during the study.

Participants must have English fluency sufficient to complete study measures.

Exclusion Criteria:

- Participation in other interventional research.

- History of penetrating head injury

- History of TBI more severe than mild by DVBIC criteria

- Diagnosis of a primary or secondary HA disorder other than PTHA

- Lifetime history of 5 or more migraine or probable migraine headaches pre-dating mTBI

- HAs of any kind of moderate or severe intensity on an average of more than 2 days per
month preceding the concussive trauma

- Continuous HAs of any kind (i.e., persistent daily HAs with no HA-free period less
than 8 hours between attacks)

- Acute or serious medical illness or unstable chronic medical illness (e.g., unstable
angina, myocardial infarction within 6 months, congestive heart failure, clinically
significant or concerning cardiac arrhythmias; preexisting hypotension [systolic
blood pressure<110] or orthostatic hypotension [systolic drop >20 mm Hg after 2 min
standing accompanied by lightheadedness], chronic renal or hepatic failure, acute
pancreatitis, Meniere's disease, or insulin-dependent diabetes, or diagnosed but
untreated sleep apnea). The eligibility of potential participants having acute
serious and/or chronic medical illnesses other than those listed will be evaluated on
a case-by-case basis by a study physician, PA-C, or ARNP.

- Use of prazosin or other alpha-1 antagonist (including but not limited to alfuzosin,
doxazosin, silodosin, tamsulosin, terazosin) for any purpose in the 4 weeks prior to
initial screen (P1) visit and prohibited throughout the study

- Allergy or previous adverse reaction to prazosin or other alpha-1 antagonist

- Active psychosis or psychotic disorder, severe depression (as determined per
clinician prescriber judgment), severe psychiatric instability or severe situational
life crisis (including evidence of being actively suicidal or homicidal).

- Meets Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)
criteria for any Substance Use Disorder except caffeine-related disorders, or
tobacco-related disorders.

- History of delirium within the prior 3 months, epilepsy, stroke, dementia, psychotic
disorder, or bipolar disorder

- Structural brain abnormalities on any prior imaging with associated clinically
evident manifestations

- Current participation in transcranial magnetic stimulation studies

- Women of childbearing potential must not be pregnant, planning to become pregnant
during the study period, or nursing.

- Participation in a HA support group or other activity such as meditation or yoga
intended to mitigate HA or other chronic pain must be stable at least 4 weeks prior
to beginning the initial screen (P1) visit and may not be started during the study

- Failure to record HA data for at least 80% of days during the Screening Period

- Not suitable for study per clinician judgement.
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