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Alpha-1 Adrenergic Blocker
Prazosin for Post-Traumatic Headaches
Phase 4
Waitlist Available
Led By Murray A Raskind, MD
Research Sponsored by Seattle Institute for Biomedical and Clinical Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
History of blast and/or impact head trauma mild traumatic brain injury (mTBI) meeting Defense and Veterans Brain Injury Center (DVBIC) mTBI criteria
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 weeks before baseline, baseline, 4,8, and 12 weeks after steady dose
Awards & highlights
Study Summary
This trial will test whether prazosin is an effective treatment for people with mTBI and chronic headaches.
Who is the study for?
This trial is for active-duty service members or veterans aged 18 or older who have had a mild traumatic brain injury (mTBI) from blast/impact and suffer from frequent headaches that started within 3 months after the injury. They must not be pregnant, planning to become pregnant, or nursing, and should not have severe psychiatric conditions, substance use disorders (except caffeine/tobacco), or be involved in other interventional research.Check my eligibility
What is being tested?
The study aims to determine if prazosin can help treat chronic headaches in individuals with mTBI. Prazosin is FDA-approved for high blood pressure but not yet for mTBI-related headaches. Participants will either receive prazosin or a placebo to compare the effects on headache frequency and severity.See study design
What are the potential side effects?
Prazosin may cause side effects such as dizziness, sleepiness, nausea, weakness, palpitations (feeling your heartbeat), breathing difficulties, depression symptoms worsening if already present; however specific side effects related to headache treatment are being studied.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a mild brain injury from a blast or impact.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 weeks before baseline, baseline, 4,8, and 12 weeks after steady dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 weeks before baseline, baseline, 4,8, and 12 weeks after steady dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in headache frequency
Secondary outcome measures
Insomnia Severity Index
Overall sleep quality as assessed by Pittsburgh Sleep Quality Index
Side effects data
From 2017 Phase 4 trial • 20 Patients • NCT0219965220%
fainting
10%
psychiatric hospitalization
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Prazosin
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PrazosinExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
Placebo capsules
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prazosin
FDA approved
Find a Location
Who is running the clinical trial?
Seattle Institute for Biomedical and Clinical ResearchLead Sponsor
52 Previous Clinical Trials
13,172 Total Patients Enrolled
VA Puget Sound Health Care SystemFED
65 Previous Clinical Trials
227,564 Total Patients Enrolled
Madigan Army Medical CenterFED
48 Previous Clinical Trials
17,976 Total Patients Enrolled
1 Trials studying Post-Traumatic Headache
64 Patients Enrolled for Post-Traumatic Headache
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a traumatic brain injury (TBI) that was more than mild according to DVBIC criteria.You are currently involved in studies using transcranial magnetic stimulation.I am not pregnant, planning to become pregnant, or breastfeeding.You have had an allergic reaction to prazosin or similar medications before.You have a diagnosed substance use disorder, except for caffeine or tobacco-related disorders.I have had brain abnormalities with symptoms shown on scans.I have been consistently participating in activities like support groups, meditation, or yoga for at least 4 weeks to help with my chronic pain.I am a healthy adult over 18 and either an active-duty servicemember or a veteran.I experienced moderate to severe headaches on most days before my head injury.I haven't taken prazosin or similar medications in the last 2 weeks.I have not had delirium, epilepsy, stroke, dementia, psychosis, or bipolar disorder in the last 3 months.My headaches started or got much worse after a head injury 3 months ago.My symptoms have been stable and occurring for at least 3 months.You have had a head injury where something has gone into your head.My headaches last 4+ hours or I take medication to manage them.You are currently experiencing severe mental health issues or a major life crisis.My main headache symptoms are not caused by migraines or tension headaches.I do not have any serious or unstable chronic illnesses.I have had a mild brain injury from a blast or impact.
Research Study Groups:
This trial has the following groups:- Group 1: Prazosin
- Group 2: Placebo
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Prazosin deemed a safe therapy for individuals?
"Thanks to its Phase 4 status, Prazosin can be thought of as a safe medication; thus it is given a 3 out of 3 in terms of safety."
Answered by AI
What other exploratory research has been conducted with Prazosin?
"Presently, there are seven ongoing studies for Prazosin with one of those trials in its final phase. The majority of these research sites are located within Seattle, Washington; however, a total of nine different medical locations have recruited patients to participate in the investigation."
Answered by AI
Is there still an opportunity for individuals to enroll in this experiment?
"Affirmative. As per information on clinicaltrials.gov, this research is presently enrolling participants with the initial posting being on November 29th 2016 and the most recent update occurring September 22nd 2022. A total of 228 individuals are to be welcomed at 2 sites for involvement in the trial."
Answered by AI
How many participants are currently engaged in this medical experiment?
"Indeed, according to the information on clinicaltrials.gov this study is still seeking participants. It was first made available Nov 29th 2016 and has been recently updated on Sep 22nd 2022. Currently, 228 patients need to be recruited from 2 distinct locations."
Answered by AI
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