Pediatric Concussion Outcomes

• Status: Enrolling by invitation
• Trial end date: 2022-08-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lancaster General Hospital
• Treatments: Nortriptyline

Criteria

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. Male or female, aged 13-18 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. Agreement to avoid over the counter supplements

9. Agreement to adhere to 3x weekly dosing of NSAIDs to avoid rebound headache from overuse.

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 abnormality on Computed Tomography (if obtained)

3. History of known neurological disorder (history of prior TBI, seizure disorder)

4. History of known psychiatric disease (ex. ADHD, anxiety, depression) given the potential side effects of the study drug.

5. Current suicidal ideation as screened for on PHQ-A on intake

6. Current treatment with antidepressants

7. A personal history of Brugada syndrome

8. Known allergic reaction to nortriptyline

9. Current pregnancy