Pediatric Concussion Outcomes

Phase 4

Terminated

• Conditions: Headaches Posttraumatic; Concussion Post Syndrome; Mild Traumatic Brain Injury
• Interventions: Drug: Placebo; Drug: Nortriptyline

• Registration Number: NCT04226365
• Lead Sponsor: Lancaster General Hospital

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.

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 Timeline

• Study First Submitted: 2020-01-09
• Study First Submitted QC: 2020-01-09
• Study First Posted: 2020-01-13
• Study Start: 2020-02-15
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-24
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	10mg capsule once daily for 4 weeks of Thick-It filler
Experimental	Nortriptyline	10mg capsule once daily for 4 weeks of nortriptyline

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Penn Medicine Lancaster General Health; 🇺🇸 Lancaster, Pennsylvania, United States