Pediatric Concussion Outcomes (PeCon)

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: Active, not recruiting
• Conditions: Mild Traumatic Brain Injury; Concussion Post Syndrome; Headaches Posttraumatic
• Intervention / Treatment: Drug: Nortriptyline; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 16 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

How is the study designed?

Design Details

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

Number of Arms

2

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	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

• 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

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2020
• Primary Completion (Actual): June 1, 2023
• Study Completion (Estimated): March 1, 2024

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 (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: mild TBI; headache; concussion; post concussion
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Headache Disorders; Head Injuries, Closed; Wounds, Nonpenetrating; Headache Disorders, Secondary; Brain Injuries; Brain Injuries, Traumatic; Headache; Post-Concussion Syndrome; Brain Concussion; Post-Traumatic Headache; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Tricyclic; Adrenergic Uptake Inhibitors; Nortriptyline
• Other Study ID Numbers: 2019-83

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