Chronic Postconcussive Headache: A Placebo-Controlled Treatment Trial of Prazosin (NCT02266329) | Clinical Trial Compass
CompletedPhase 1/2
Chronic Postconcussive Headache: A Placebo-Controlled Treatment Trial of Prazosin
United States89 participantsStarted 2016-01-04
Plain-language summary
The purpose of this study is to determine if prazosin is more effective than placebo in decreasing frequency, severity, disability, and other negative effects of headaches related to mild traumatic brain injury in Service Members and Veterans.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Veterans or active duty service members aged 18 or older of either gender
* Good general health
* History of blast and/or impact head/neck trauma meeting DVBIC criteria for mild TBI, i.e., injury as manifested by at least one of the following:
* 1\) any period of loss of consciousness
* 2\) any loss of memory for events immediately before or after the accident
* 3\) any alteration in mental status at the time of the accident (e.g., feeling dazed, disoriented, or confused)
* 4\) focal neurological deficit(s) that may or may not be transient, with severity of injury not exceeding loss of consciousness 30 minutes, Glasgow Coma Scale \<13-15 after 30 minutes, or posttraumatic amnesia \>24 hrs,
* Headaches that started within 3 months of a head/neck injury or pre-existing headaches that markedly worsened (by a two-fold or greater increase in frequency and/or severity) within 3 months of a head/neck injury. Headaches must either 1) 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 uses a medication or other agent in an effort to stop the headache. Headaches meeting these criteria must have been present on average at least 8 days per 4-week period over the 3 months preceding study enrollment.
* Comorbid PTSD or other anxiety disorder is not exclusionary.
* Fluency in English is required.
* Persons of all races and ethnicities are eligible.
* …