Prazosin for Post-Concussive Headaches
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02965027|
Recruitment Status : Recruiting
First Posted : November 16, 2016
Last Update Posted : January 28, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Post-Traumatic Headache||Drug: Prazosin Drug: Placebos||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||228 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Prazosin for the Prophylaxis of Chronic Post-Traumatic Headaches in OEF/OIF/OND Service Members and Veterans With Mild TBI|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
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.
Other Name: Minipress
Placebo Comparator: Placebo
- Change from baseline in headache frequency [ Time Frame: 5 weeks before baseline, baseline, 4,8, and 12 weeks after steady dose ]Headache log to be filled out by participant
- Overall sleep quality as assessed by Pittsburgh Sleep Quality Index [ Time Frame: baseline, 4, 8, 12 weeks after steady dose ]
- Insomnia Severity Index [ Time Frame: baseline, 4, 8, 12 weeks after steady dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02965027
|Contact: Kelly Huynh||206-277-3491|
|Contact: Laura Crews, RN, BSN||253-968-3161|
|United States, Washington|
|VA Puget Sound Health Care System||Recruiting|
|Seattle, Washington, United States, 98108|
|Contact: Kelly Huynh 206-277-3491|
|Principal Investigator: Murray A Raskind, MD|
|Sub-Investigator: Cynthia Mayer, DO|
|Sub-Investigator: Elaine R Peskind, MD|
|Madigan Army Medical Center||Recruiting|
|Tacoma, Washington, United States, 98433|
|Contact: Laura Crews, RN, BSN 253-968-3161|
|Principal Investigator: Paul Savage, MD|
|Principal Investigator:||Murray A Raskind, MD||VA Puget Sound Health Care System|