Male and female Active-duty SMs or Veterans aged 18 or older 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 HAs that started within 3months 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.

NCT02965027_inc_T1
Person
Male
NCT02965027_inc_T2
Person
female
NCT02965027_inc_T3
Person
Active-duty SMs
NCT02965027_inc_T4
Person
Veterans
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Value
18 or older
NCT02965027_inc_T6
Person
aged
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Condition
good general health
NCT02965027_inc_T8
Observation
blast
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Observation
History of
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Condition
impact head trauma
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Measurement
Defense and Veterans Brain Injury Center (DVBIC) mTBI criteria
NCT02965027_inc_T12
Value
meeting
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Condition
alteration in consciousness
NCT02965027_inc_T14
Temporal
for up to 24 hours after the injury
NCT02965027_inc_T15
Reference_point
the injury
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Condition
loss of consciousness
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Temporal
0-30 minutes
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Condition
post-traumatic amnesia
NCT02965027_inc_T19
Temporal
up to 1 day post-injury
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Measurement
Glasgow Coma Scale
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Value
13-15
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Procedure
head imaging
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Condition
findings
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Negation
negative
NCT02965027_inc_T25
Scope
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
NCT02965027_inc_T26
Condition
HAs
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Qualifier
Frequent
NCT02965027_inc_T28
Temporal
within 3months after a head injury
NCT02965027_inc_T29
Reference_point
a head injury
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Condition
HAs
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Multiplier
last 4 or more hours a day
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Qualifier
moderate to severe intensity
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Drug
triptan
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Drug
ergotamine
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Multiplier
at least 8 days per 4-week period
NCT02965027_inc_T36
Temporal
within 30 days after head injury
NCT02965027_inc_T37
Temporal
at least 3 months prior to the Initial Screening Visit
NCT02965027_inc_T38
Reference_point
the Initial Screening Visit
NCT02965027_inc_T39
Scope
last 4 or more hours a day and reach a moderate to severe intensity
NCT02965027_inc_T40
Scope
triptan or ergotamine
NCT02965027_inc_T41
Scope
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