PeCon: Pediatric Concussion Outcomes

Sponsor

Lancaster General Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04226365

Collaborator

(none)

100

Enrollment

Location

Arms

65.5

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Concussion Post Syndrome Headaches Posttraumatic Mild Traumatic Brain Injury	Drug: Nortriptyline Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 15, 2020

Anticipated Primary Completion Date :

Feb 2, 2025

Anticipated Study Completion Date :

Aug 2, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Post-Concussive Symptom Inventory (PSCI) score [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged 13-18 years old
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
Ability to take oral medication and be willing to adhere to the medication regimen
No loss of consciousness OR loss of consciousness <30 minutes
Headache symptoms persisting ≥4 weeks post trauma
PCSHE score for headache + pressure in head + neck pain must be > 3
Between weeks 4 and 12 post-concussion at time of enrollment
Agreement to avoid over the counter supplements
Agreement to adhere to 3x weekly dosing of NSAIDs to avoid rebound headache from overuse.
Patient of LGHP Sports Medicine who is currently playing an organized sport

Exclusion Criteria:

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

Focal neurological deficits following injury
Any abnormality on Computed Tomography (if obtained)
History of known neurological disorder (history of prior TBI, seizure disorder)
History of known psychiatric disease (ex. ADHD, anxiety, depression) given the potential side effects of the study drug.
Current suicidal ideation as screened for on PHQ-A on intake
Current treatment with antidepressants (unless a stable medical regimen is in place for at least 6 months per provider assessment)
A personal history of Brugada syndrome
Known allergic reaction to nortriptyline
Current pregnancy
Use of nortriptyline in prior 6 months
Positive COVID-19 test in prior 90 days

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penn Medicine Lancaster General Health	Lancaster	Pennsylvania	United States	17602

Sponsors and Collaborators

Lancaster General Hospital

Investigators

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