MedTrace Logo

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

NCT02266329 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2026-03-30

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine if prazosin is more effective than placebo in decreasing frequency, severity, disability, and other negative effects of headaches related to mild traumatic brain injury in Service Members and Veterans.

Conditions

  • Posttraumatic Headache
  • Combat Disorders
  • Post Concussion Syndrome
  • Headache
  • Mild Traumatic Brain Injury
  • Posttraumatic Migraine

Interventions

DRUG

prazosin hydrochloride

Prazosin as oral capsules titrated 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.

DRUG

placebo

Oral capsules of placebo identical in appearance to prazosin capsules titrated in the same manner as prazosin.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Cynthia L Mayer, DO · VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-04
Primary Completion
2023-05-31
Completion
2023-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02266329 on ClinicalTrials.gov