Trial · NCT02965027
Prazosin for Post-Concussive Headaches
NCT02965027, Phase 4, Completed, Seattle Institute for Biomedical and Clinical Research; results first posted 2024-07-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Prazosin for Post-Concussive Headaches. Trials, record NCT02965027. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02965027
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prazosin for Post-Concussive Headaches
- NCT number
- NCT02965027
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 89 participants, actual
- Lead sponsor
- Seattle Institute for Biomedical and Clinical Research
- Conditions
- Post-Traumatic Headache
- Interventions
- Prazosin, Placebo
- First posted
- 2016-11-16
- Last updated
- 2024-07-10
- Results first posted
- 2024-07-10
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Headache Frequency | baseline, 4,8, and 12 weeks after steady dose | Headache log completed by participant to capture number of headaches experienced. |
| Secondary | Overall Sleep Quality as Assessed by Pittsburgh Sleep Quality Index | baseline, 4, 8, 12 weeks after steady dose | Overall sleep quality assessed utilizing the Pittsburgh Sleep Quality Index (PSQI). The PSQI contains 19 self-rated questions. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. The seven component scores are then added to yield one "global" score with a range of 0-21 points, "0" indicating no difficulty and "21" indicating sever difficulty in all areas. Minimum Score = 0 (better); Maximum Score = 21 (worse). Interpretation: TOTAL \< 5 associated with good sleep quality. TOTAL \> 5 associated with poor sleep quality The difference between means is shown for weeks 4, 8 and 12. |
| Secondary | Insomnia Severity Index | baseline, 4, 8, 12 weeks after steady dose | Insomnia severity assessed using the Insomnia Severity Index (ISI). This 7-item self-report is designed to measure and detect cases of insomnia. Each question is scored on a scale of 0 to 4. The 7 items are added together. Sum scores for items 1-7 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe) The difference between means is shown for weeks 4, 8 and 12. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Headache Frequency | baseline, 4,8, and 12 weeks after steady dose | headaches per month | MEAN | |
| SECONDARY | Overall Sleep Quality as Assessed by Pittsburgh Sleep Quality Index | baseline, 4, 8, 12 weeks after steady dose | score on a scale | MEAN | |
| SECONDARY | Insomnia Severity Index | baseline, 4, 8, 12 weeks after steady dose | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Headache Frequency | Prazosin | Baseline | 16.4 | Standard Error 1.2 | headaches per month |
| Change From Baseline in Headache Frequency | Placebo | Baseline | 18.5 | Standard Error 1.6 | headaches per month |
| Change From Baseline in Headache Frequency | Prazosin | Week 4 - Baseline | -9.2 | Standard Error 0.9 | headaches per month |
| Change From Baseline in Headache Frequency | Placebo | Week 4 - Baseline | -7.4 | Standard Error 1.2 | headaches per month |
| Change From Baseline in Headache Frequency | Prazosin | Week 8 - Baseline | -9.9 | Standard Error 0.9 | headaches per month |
| Change From Baseline in Headache Frequency | Placebo | Week 8 - Baseline | -9.1 | Standard Error 1.2 | headaches per month |
| Change From Baseline in Headache Frequency | Prazosin | Week 12 - Baseline | -10.7 | Standard Error 0.9 | headaches per month |
| Change From Baseline in Headache Frequency | Placebo | Week 12 - Baseline | -6.9 | Standard Error 1.3 | headaches per month |
| Overall Sleep Quality as Assessed by Pittsburgh Sleep Quality Index | Prazosin | Baseline | 12.1 | Standard Error 0.6 | score on a scale |
| Overall Sleep Quality as Assessed by Pittsburgh Sleep Quality Index | Placebo | Baseline | 12.0 | Standard Error 0.8 | score on a scale |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 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 events36
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 | 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 | Lightheadedness | General disorders | Prazosin | 28 | 59 | 32 |
| other | Lightheadedness | General disorders | Placebo | 11 | 30 | 11 |
| other | Vertigo | General disorders | Prazosin | 1 | 59 | 1 |
| other | Vertigo | General disorders | Placebo | 1 | 30 | 1 |
| other | Nasal Congestion | General disorders | Prazosin | 19 | 59 | 21 |
| other | Nasal Congestion | General disorders | Placebo | 3 | 30 | 3 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse 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.
Grants0
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.
None in this release.
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.
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/NCT02965027
GET https://conductscience.org/api/trials/v1/NCT02965027/results?page=2