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Pediatric Concussion Outcomes

NCT04226365 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-09-10

Study results available
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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.

Conditions

  • Concussion Post Syndrome
  • Headaches Posttraumatic
  • Mild Traumatic Brain Injury

Interventions

DRUG

Nortriptyline

10mg capsule Nortryptyline

DRUG

Placebo

10mg capsule Thick-It filler

Sponsors & Collaborators

  • Lancaster General Hospital

    lead OTHER

Principal Investigators

  • Patrick Moreno, MD · Lancaster General Health Sports Medicine

  • Laura DiPaolo, MD · Lancaster General Health Sports Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-15
Primary Completion
2023-05-31
Completion
2023-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04226365 on ClinicalTrials.gov