Trial Outcomes & Findings for Chronic Postconcussive Headache: A Placebo-Controlled Treatment Trial of Prazosin (NCT NCT02266329)

166 participants completed the informed consent process, agreeing to participation. 77 of those participants failed the screening process, declined to participate prior to study drug randomization, or were lost to follow-up prior to study drug randomization. 89 participants were randomized to study drug.

Chronic Postconcussive Headache: A Placebo-Controlled Treatment Trial of Prazosin

Change from baseline (pre-treatment) to Week 12 (i.e., following 12 weeks of drug treatment) of either 1) Headaches that last 4 or more hours a day and reach a moderate to severe intensity at any point or 2) Headaches of any intensity if a medication or other treatment is used in an effort to stop the Headaches, as determined from Headache Log data.

The HIT-6 measures the impact that headaches have on a person's ability to function in daily activities, such as work, school, home, and social situations. It assesses the severity and effect of headaches on one's quality of life. The HIT-6 consists of 6 items, each scored on a Likert scale. Never = 6 points, Rarely = 8 points, Sometimes = 10 points, Very Often = 11 points, Always = 13 points. The total score is obtained by summing the individual item scores. Minimum score = 36. Maximum score = 78. This outcome measure is assessing the change between Baseline scores and 12 week scores in Headache-Related Disability. Increasing Values indicate a worse outcome, representing a higher impact of headaches on daily life. Decreasing Values indicate a better outcome, representing a lower impact of headaches on daily life.

PCL-5 is a self-report measure that assesses the presence and severity of Posttraumatic Stress Disorder (PTSD) symptoms based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. The PCL-5 includes 20 items, each corresponding to a PTSD symptom. Each item is rated on a 5-point Likert scale from 0 = not at all to 4 = extremely. The total score is calculated by summing the scores for each of the 20 items. Minimum Score = 0. Maximum Score = 80. This outcome measure is assessing the change between Baseline scores and 12 week scores in PTSD symptoms. Increasing Values indicate a worse outcome, representing a higher severity of PTSD symptoms. Decreasing Values indicate a better outcome, representing a lower severity of PTSD symptoms.

The PSQI measures the quality and patterns of sleep in adults. It assesses various dimensions of sleep over a one-month time period. The PSQI comprises 19 self-rated questions. The self-rated questions are grouped into seven components, each scoring between 0 and 3: Sleep quality Sleep latency Sleep duration Habitual sleep efficiency Sleep disturbances Use of sleeping medication Daytime dysfunction These seven component scores are summed to yield a global PSQI score. Minimum Score = 0. Maximum Score = 21. This outcome measure is assessing the change between Baseline scores and 12 week scores in sleep. Increasing scores indicate worse outcome, representing poorer sleep quality and more severe sleep disturbances. Decreasing scores indicate better outcome representing better sleep quality and fewer sleep disturbances.

The NSI is a self-report measure used to assess the severity of post-concussive symptoms and neurobehavioral issues often experienced after a traumatic brain injury (TBI). It covers physical, cognitive, and emotional symptoms. The NSI includes 22 items, each rated on a 5-point Likert scale rating symptoms from None = 0 to Very Severe = 4. The total score is obtained by summing the scores for each of the 22 items. Minimum Score = 0. Maximum Score = 88. This outcome measure is assessing the change between Baseline scores and 12 week scores in concussion-related symptoms. Increasing Values indicate a worse outcome, representing more severe neurobehavioral symptoms. Decreasing Values indicate a better outcome representing less severe neurobehavioral symptoms.

The PHQ-9 is a self-administered tool used to screen, diagnose, monitor, and measure the severity of depression. It is based on the nine criteria for major depressive disorder in the DSM-IV (and is also consistent with DSM-5). The PHQ-9 consists of 9 items, each corresponding to a symptom of depression. Each item is rated on a 4-point Likert scale with None at all = 0 to Nearly every day = 3. The total score is calculated by summing the scores for each of the 9 items. Minimum Score = 0. Maximum Score = 27. This outcome measure is assessing the change between Baseline scores and 12 week scores in Depressive Symptoms. Increasing Values indicate a worse outcome, representing more severe depression symptoms. Decreasing Values indicate a better outcome, representing fewer or less severe depression symptoms.

The AUDIT-C is a brief screening tool used to identify hazardous drinking and alcohol use disorders. It focuses on alcohol consumption behaviors. The AUDIT-C consists of 3 items, each assessing a different aspect of alcohol consumption: Frequency of drinking alcohol. Quantity of alcohol consumed on a typical drinking day. Frequency of heavy drinking episodes. Each item is scored on a 5-point scale from 0 points = Never or none to 4 points indicating high frequency or quantity. The total score is calculated by summing the scores for the three items. Minimum Score = 0. Maximum score = 12. This outcome measure is assessing the change between Baseline scores and 12 week scores in alcohol use. Increasing Values indicate a worse outcome, representing higher levels of alcohol consumption and an increased risk of alcohol use disorders. Decreasing Values indicate better outcome, representing lower levels of alcohol consumption and a lower risk of alcohol use disorders.

The MoCA is a brief cognitive screening tool designed to assist in the detection of mild cognitive impairment. It evaluates various domains of cognitive function including memory, attention, language, visuospatial skills, and executive functions. The MoCA consists of 12 tasks which together assess multiple cognitive domains. The tasks include: Visuospatial/Executive, Naming, Memory, Attention, Language, Abstraction, Delayed Recall, Orientation. The total score is summed from the individual task scores, with certain sections having specific scoring criteria. Minimum Score = 0. Maximum Score = 30. Increasing Values indicate a better cognitive outcome, with higher scores reflecting better cognitive function. Decreasing Values indicate a worse cognitive outcome, with lower scores suggesting greater cognitive impairment.

Number of patients with a 50% or more decrease in mean number of headache days per 4 weeks, as determined at 4 week treatment intervals using Headache Log data.

UPSIS measures ictal (during headache) and interictal (outside of headache) photophobia and its adverse effects on functioning. 12 items are scored on a 0-5 Likert scale, 0 = no impact, 5 = severe impact. Items are summed. Minimum = 0 (no photophobia-related impact). Maximum = 60 (maximum impact across all items). Higher total scores indicate worse outcomes (greater impact of photophobia on daily life).

An infrared camera to measure the diameter of the pupil both during darkness and following brief pulses of light.

Frequency of Use of Abortive/Analgesic Agents at Baseline (average of 4 weeks pre-treatment) to Week 12 (average of 4 weeks following 12 weeks of drug treatment). A higher number indicates more days of abortive/analgesic agent use; a lower number indicates fewer days of use.

Total Number of Hours of headache pain over 4-weeks prior to Baseline compared to Total Number of Hours of headache pain average over 4-weeks prior to the 12-week visit using headache log data. Score is number of hours of pain. A lower score indicates less pain. A higher score indicates more pain.

Peak headache severity average over 4-weeks prior to Baseline compared to the peak headache severity average over 4-weeks prior to the 12-week visit using headache log data. Scored in a scale of 0=none, 1= mild, 2=moderate, or 3=severe.