Chronic Postconcussive Headache: A Placebo-Controlled Treatment Trial of Prazosin
CompletedPhase 1, Phase 2NCT02266329
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Chronic Postconcussive Headache: A Placebo-Controlled Treatment Trial of Prazosin
- Conditions
- Posttraumatic Headache
- Combat Disorders
- Post Concussion Syndrome
- Headache
- Mild Traumatic Brain Injury
- Posttraumatic Migraine
- Interventions
- Drug: prazosin hydrochloride
- Drug: placebo
- Sponsor
- VA Office of Research and Development
- Start date
- 2016-01-04
- Primary completion
- 2023-05-31
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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. * Female participants must agree to abstain from sexual relations that could result in pregnancy or use a reliable form of birth control during the study. * Continued use of prophylactic migraine medication other than the study drug is permissible if the participant has been on a stable dose for at least 4 weeks prior to the preliminary screening period and intends to continue the medication for the duration of the trial. Exclusion Criteria: * Participation in other interventional research. * History of TBI more severe than that classified as mild by DVBIC criteria * A primary non migraine and/or tension-type headache disorder that accounts for the majority of current symptoms * History of penetrating head injury * Headaches of any kind of moderate or severe intensity on an average of more than 4 days per month preceding the concussive trauma * Acute or unstable chronic medical illness (e.g., unstable angina, myocardial infarction within 6 months, congestive heart failure, symptomatic or concernin…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02266329