Pediatric Concussion Outcomes

Mild Traumatic Brain Injury Clinical Trial

— PeCon  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04226365
• Other study ID #: 2019-83
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: February 15, 2020
• Est. completion date: March 2024

Study information

• Verified date: February 2024
• Source: Lancaster General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: March 2024
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Concussion Post Syndrome
• Headache
• Headaches Posttraumatic
• Mild Traumatic Brain Injury
• Post-Concussion Syndrome
• Post-Traumatic Headache

Intervention

Drug:
• Nortriptyline
10mg capsule Nortryptyline
• Placebo
10mg capsule Thick-It filler

Locations

Country	Name	City	State
United States	Penn Medicine Lancaster General Health	Lancaster	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Lancaster General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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