Pediatric Concussion Outcomes (PeCon)

September 9, 2025 updated by: Lancaster General Hospital

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17602
        • Penn Medicine Lancaster General Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 14 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Participants aged 13-21 years old
  4. In good general health as evidenced by medical history and diagnosed with recent head trauma meeting ICHD-3 criteria for acute posttraumatic headache with symptom onset < 7 days from trauma
  5. Ability to take oral medication and be willing to adhere to the medication regimen
  6. No loss of consciousness OR loss of consciousness <30 minutes
  7. Headache symptoms persisting ≥4 weeks post trauma
  8. PCSHE score for headache + pressure in head + neck pain must be > 3
  9. After week 4 post-concussion at time of enrollment
  10. Not currently receiving pharmacologic treatment for concussion asid from NSAIDs and acetaminophen

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Focal neurological deficits following injury
  2. Any acute abnormality on Computed Tomography (if obtained)
  3. History of known seizure disorder or moderate or severe TBI
  4. Current uncontrolled psychiatric illness given the potential side effects of the study drug (at investigator discretion).
  5. Current suicidal ideation as screened for on PHQ on intake
  6. A personal history of Brugada syndrome
  7. Known allergic reaction to nortriptyline
  8. Current pregnancy
  9. Positive COVID-19 test in prior 14 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
10mg capsule once daily for 4 weeks of nortriptyline
Drug: Nortriptyline
10mg capsule Nortryptyline
Other Names:
  • Pamelor
Placebo Comparator: Control
10mg capsule once daily for 4 weeks of Thick-It filler
Drug: Placebo
10mg capsule Thick-It filler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-Concussive Symptom Inventory (PSCI) Score
Time Frame: 4 weeks
Post-Concussive Symptom Inventory (PSCI) score of 0-1 on the headache symptom, where the score ranges from 0 (absent) to 6 (severe). A score of 0 is optimal, while a score of 6 is not optimal.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lancaster General Hospital

Investigators

  • Principal Investigator: Patrick Moreno, MD, Lancaster General Health Sports Medicine
  • Principal Investigator: Laura DiPaolo, MD, Lancaster General Health Sports Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2020

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

January 9, 2020

First Submitted That Met QC Criteria

January 9, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Estimated)

September 10, 2025

Last Update Submitted That Met QC Criteria

September 9, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-83

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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