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prazosin for Headache
Phase 1 & 2
Waitlist Available
Led By Cynthia L Mayer, DO
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 weeks
Awards & highlights
Study Summary
This trial will compare the effects of prazosin to a placebo in Service Members and Veterans who suffer from headaches due to mild traumatic brain injury.
Eligible Conditions
- Post-Traumatic Headaches
- Concussion
- Headache
- Migraine
- Post-Traumatic Stress Disorder
- Post-Concussion Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 weeks
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 (HA) Frequency
Secondary outcome measures
Change from Baseline in 4-week Average Peak HA Severity
Change from Baseline in 4-week Average Total Number of Hours of HA Pain
Change from Baseline in Alcohol Use
+10 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: prazosinActive Control1 Intervention
Subjects will be gradually titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose to be used in this trial is 5mg in the morning and 20 mg at bedtime.
Group II: placeboPlacebo Group1 Intervention
Subjects will be gradually titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose to be used in this trial is 5mg in the morning and 20 mg at bedtime.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,437 Total Patients Enrolled
6 Trials studying Headache
418 Patients Enrolled for Headache
Cynthia L Mayer, DOPrincipal InvestigatorVA Puget Sound Health Care System Seattle Division, Seattle, WA
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You mainly experience headaches that are not migraines or tension-type headaches.You have frequent moderate to severe headaches (pain in your head) happening more than 4 days a month before the head injury.You have a history of a traumatic brain injury that was more severe than what is considered a mild injury.You have had a head or neck injury from a blast or impact, which caused mild traumatic brain injury (TBI).You are currently involved in studies using transcranial magnetic stimulation.You have had a serious head injury where something has gone through your skull.If you participate in a headache support group or do activities like meditation or yoga to help with your headaches or chronic pain, you need to keep doing them regularly for at least 4 weeks before starting the screening process for the trial. It's also important that you plan to continue these activities throughout the trial. If you haven't started these activities yet, it's best to wait until after the trial is over before you begin.You have had headaches within 3 months of a head/neck injury, or your pre-existing headaches have gotten significantly worse after a head/neck injury. These headaches last for at least 4 hours a day and can be moderate to severe in intensity. If you use medication or other methods to try to stop the headache, it can be of any severity or duration. These headaches must have occurred for at least 8 days in a 4-week period over the 3 months before joining the study.You are in good overall health.Having PTSD or another anxiety disorder doesn't prevent you from participating.
Research Study Groups:
This trial has the following groups:- Group 1: prazosin
- Group 2: placebo
Awards:
This trial has 2 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
For what medical conditions is prazosin typically prescribed?
"Prazosin has multiple applications, including the management of post traumatic stress disorder (PTSD), hypertension, nocturnal terrors and benign prostatic hyperplasia (BPH)."
Answered by AI
Could you provide an estimate of the total number of individuals enrolled in this experiment?
"Affirmative, the information posted on clinicaltrials.gov states that this research is actively seeking participants. This project was first listed on April 1st 2016 and its most recent update was October 24th 2022; 228 patients are required across a single medical centre."
Answered by AI
Is there any availability for participants in this research program?
"Affirmative. Data posted on clinicaltrials.gov suggests that this medical trial is still open for participants; it was initially published on April 1st 2016, and modified last on October 24th 2022. This research seeks to enrol 228 subjects from a single site."
Answered by AI
To what extent has prazosin been explored in academic research?
"Currently, 7 clinical trials are investigating prazosin with 1 of these in the advanced Phase 3 stage. These studies span 9 locations primarily based around Seattle, Washington."
Answered by AI
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