Trial · NCT02266329

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

NCT02266329, Phase 1, Phase 2, Completed, VA Office of Research and Development; results first posted 2024-06-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Chronic Postconcussive Headache: A Placebo-Controlled Treatment Trial of Prazosin. Trials, record NCT02266329. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02266329

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Chronic Postconcussive Headache: A Placebo-Controlled Treatment Trial of Prazosin
NCT number: NCT02266329
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 89 participants, actual
Lead sponsor: VA Office of Research and Development
Conditions: Posttraumatic Headache, Combat Disorders, Post Concussion Syndrome, Headache, Mild Traumatic Brain Injury, Posttraumatic Migraine
Interventions: prazosin hydrochloride, placebo
First posted: 2014-10-17
Last updated: 2026-03-30
Results first posted: 2024-06-26
Limitations and caveats: Change from baseline in headache (HA) frequency (1. Primary Outcome Measure) is based on linear mixed effects regression of outcome on study visit by treatment interaction with study participant as a random effect.

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Headache Diary	Baseline to 12 weeks	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.
Secondary	Headache Impact Test-6 (HIT-6)	Baseline to 12 weeks	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.
Secondary	PTSD Checklist for DSM-5 (PCL-5)	Baseline to 12 weeks	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.
Secondary	Pittsburgh Sleep Quality Index (PSQI)	Baseline to 12 weeks	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.
Secondary	Neurobehavioral Symptom Inventory (NSI)	Baseline to 12 weeks	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.
Secondary	Patient Health Questionnaire-9 (PHQ-9)	Baseline to 12 weeks	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.
Secondary	Alcohol Use Disorders Identification Test - Consumption (AUDIT-C)	Baseline to 12 weeks	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.
Secondary	Montreal Cognitive Assessment (MoCA)	Baseline to 12 weeks	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.
Secondary	Number of Patients With a 50% or More Decrease in Mean Number of Headache Days Per 4 Weeks	Baseline to 12 weeks	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.
Secondary	Photophobia - Utah Photophobia Symptom Impact Scale-12-Modified (UPSIS-12M)	Baseline to Week 12	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).

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Headache Diary	Baseline to 12 weeks	headaches per month	MEAN
SECONDARY	Change From Baseline in 4-week Average Peak HA Severity	Baseline to 12 weeks
SECONDARY	Change From Baseline in 4-week Average Total Number of Hours of HA Pain	Baseline to 12 weeks
SECONDARY	Change From Baseline in Frequency of Use of Abortive/Analgesic Agents	Baseline to 12 weeks
SECONDARY	Change From Baseline in Headache-Related Disability	Baseline to 12 weeks
SECONDARY	Change From Baseline in Posttraumatic Stress Disorder (PTSD) Symptoms	Baseline to 12 weeks
SECONDARY	Change From Baseline in Sleep Measures	Baseline to 12 weeks
SECONDARY	Change From Baseline in Concussion-Related Symptoms	Baseline to 12 weeks
SECONDARY	Change From Baseline in Depressive Symptoms	Baseline to 12 weeks
SECONDARY	Change From Baseline in Alcohol Use	Baseline to 12 weeks

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Headache Diary	Prazosin		-10.7	Standard Error 0.9	headaches per month
Headache Diary	Placebo		-6.9	Standard Error 1.3	headaches per month

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Prazosin	59
Overall Study	STARTED	Placebo	30
Overall Study	COMPLETED	Prazosin	52
Overall Study	COMPLETED	Placebo	26
Overall Study	NOT COMPLETED	Prazosin	7
Overall Study	NOT COMPLETED	Placebo	4

Source ClinicalTrials.gov

Adverse events34

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Palpitations	Cardiac disorders	Prazosin	21	59	23
other	Palpitations	Cardiac disorders	Placebo	6	30	6
other	Nausea	Gastrointestinal disorders	Prazosin	20	59	25
other	Nausea	Gastrointestinal disorders	Placebo	4	30	4
other	Dizziness (any)	General disorders	Prazosin	37	59	51
other	Dizziness (any)	General disorders	Placebo	6	30	7
other	Dizziness on Standing	General disorders	Prazosin	24	59	30
other	Dizziness on Standing	General disorders	Placebo	1	30	1
other	Drowsiness/Lethargy	General disorders	Prazosin	26	59	30
other	Drowsiness/Lethargy	General disorders	Placebo	5	30	5

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Prazosin	0	59
Total, all-cause mortality	Placebo	0	30
Total, other adverse events	Prazosin	52	59
Total, other adverse events	Placebo	22	30
Total, serious adverse events	Prazosin	1	59
Total, serious adverse events	Placebo	1	30

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
IK2RX001136	Chronic Postconcussive Headache: A Placebo-Controlled Treatment Trial of Prazosin	MAYER, CYNTHIA L	VA PUGET SOUND HEALTHCARE SYSTEM	Veterans Affairs	2015 to 2019

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Prazosin vs Placebo: deaths from any cause	Trial comparisons
Prazosin vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02266329

GET https://conductscience.org/api/trials/v1/NCT02266329/events?page=2

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