Pediatric Concussion Outcomes — PeCon  

Mild Traumatic Brain Injury Clinical Trial

Official title: Treatment for Post-concussive Headache: A Randomized, Placebo-controlled, Double Blinded Trial

Status Terminated

Clinical Trial Summary

This is a randomized, placebo-controlled, double-blinded trial in which subjects with a post concussive headache meeting inclusion criterion will be assigned to one of two treatment groups: placebo or nortriptyline. Each group will be evaluated at week 0 and again each week for the next 4 weeks of treatment with a concussion survey that rates their symptoms. At the end of 4 weeks the study will be unblinded. It is hypothesized that the addition of nortriptyline to the standard headache treatments will result in more rapid decrease of symptom score than with placebo.

Clinical Trial Description

Participants are randomly assigned to one of two treatment groups. The experimental group receives standard headache treatment including Tylenol, NSAIDs 2-3x/week, vestibular PT and daily nortriptyline 10mg oral. The control group also receives the standard headache treatment, but will instead be given a placebo, which will look physically identical to the nortriptyline capsule and be comprised of non-active pharmaceutical grade excipient. ;

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Concussion Post Syndrome
• Headache
• Headaches Posttraumatic
• Mild Traumatic Brain Injury
• Post-Concussion Syndrome
• Post-Traumatic Headache

• NCT number: NCT04226365
• Study type: Interventional
• Source: Lancaster General Hospital
• Status: Terminated
• Phase: Phase 4
• Start date: February 15, 2020
• Completion date: May 31, 2023