CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 89 enrolled
Drug / intervention
Prazosin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02965027
NCT02965027Phase 4Completed

Prazosin for the Prophylaxis of Chronic Post-Traumatic Headaches in OEF/OIF/OND Service Members and Veterans With Mild TBI

Seattle Institute for Biomedical and Clinical Research·interventional·Posted Nov 16, 2016·Updated Jul 10, 2024

In Brief

A Phase 4 clinical trial evaluating Prazosin and Placebo for Post-Traumatic Headache. Completed, enrolled 89 participants across 2 sites.

Detailed Summary

Mild traumatic brain injury (mTBI) caused by blast effects of explosive devices has been called the "signature injury" of soldiers who served in the Iraq and Afghanistan conflicts. mTBI can also occur from impact or hitting the head on an object or the ground. Although termed "mild" in comparison to major brain injuries, people with mTBI can have problems with their memory and concentration. People with mTBI can also find they are more irritable, have more anxiety, and have trouble with their mood and sleep. The purpose of this study is to see if a medication called prazosin can help treat chronic headaches in people with mTBI. The Food and Drug Administration (FDA) has approved prazosin for treating people with high blood pressure. At this time, the FDA has not approved prazosin in the treatment of mTBI or headaches. Some people who have posttraumatic stress disorder (PTSD) and have been taking prazosin for their medical conditions or who have taken it in research studies have said they have fewer headaches.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 16, 2016
Enrollment StartNov 29, 2016
Primary CompletionMay 9, 2023
Study CompletionJun 7, 2023
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 9.6 years ago

Interventions

Prazosindrug

Placebodrug