Clinical trial NCT02965027
Conditions: Post-Traumatic Headache
Keywords: Chronic Headache Post-Traumatic Stress Disorder Iraq/Afghanistan Veteran
Sponsor: Seattle Institute for Biomedical and Clinical Research
Start date: 2016-11-29; Completion date: 2023-06-07
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Mild traumatic brain injury (mTBI) caused by blast effects of explosive devices has been called the "signature injury" of soldiers who served in the Iraq and Afghanistan conflicts. mTBI can also occur from impact or hitting the head on an object or the ground. Although termed "mild" in comparison to major brain injuries, people with mTBI can have problems with their memory and concentration. People with mTBI can also find they are more irritable, have more anxiety, and have trouble with their mood and sleep.

The purpose of this study is to see if a medication called prazosin can help treat chronic headaches in people with mTBI. The Food and Drug Administration (FDA) has approved prazosin for treating people with high blood pressure. At this time, the FDA has not approved prazosin in the treatment of mTBI or headaches. Some people who have posttraumatic stress disorder (PTSD) and have been taking prazosin for their medical conditions or who have taken it in research studies have said they have fewer headaches.

Detailed description:
Background and Rationale: Headaches following mild traumatic brain injury (mTBI) are common, can be refractory to standard therapies, and may persist and worsen to become a debilitating chronic pain syndrome. The purpose of this study is to evaluate the centrally acting alpha-1 adrenoreceptor (AR) antagonist drug prazosin as a prophylactic treatment for chronic posttraumatic headaches (PTHAs). The impetus for this study comes from a large open-label case series in Iraq and Afghanistan Veterans with mTBI and PTHAs and data from a placebo-controlled trial evaluating use of prazosin for posttraumatic stress disorder (PTSD) in active-duty Servicemembers (SMs). Findings from these studies showed that in addition to decreasing PTSD-related symptoms and improving sleep quality, prazosin decreased the frequency and severity of headaches, which were common in the study populations.

Study Objectives, Specific Aims, and Hypotheses: The objective of this study is to evaluate the efficacy of prazosin as a prophylactic treatment for persistent PTHAs, which will be accomplished by conducting a randomized placebo-controlled double blind trial of prazosin vs. placebo in active-duty SMs and Veterans who were in military service at any time from October 7, 2001 to the present with persistent PTHAs.

* Specific Aim 1: To determine the effect of prazosin compared to placebo on headache frequency, headache severity and duration, use of abortive/analgesic medications, and headache-related disability.
* Specific Aim 2: To determine the effect of prazosin on sleep disturbance, PTSD symptoms, depressive symptoms, alcohol consumption, global cognitive function, health-related quality of life, and global clinical status.

Arms: arm 1: Prazosin capsules beginning at 1 mg orally at bedtime. Titrate over 5 weeks to maximum dose of 5 mg in the morning and 20 mg at bedtime. arm 2: Placebo capsules
Interventions: intervention 1: Prazosin intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Prot_SAP_000.pdf: 
 
Title:  Prazosin for Prophylaxis of Chronic Posttraumatic 
Headaches in OEF/OIF/OND Service Members and 
Veterans with Mild TBI 
 
Brief Title: 
Prazosin for Post-Concussive Headaches 
 
NCT02965027 
 
Approved November 12, 2021