Pediatric Concussion Outcomes

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-15

Study Completion Date

2023-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Does Oral Micronized Progesterone Shorten Time of Symptoms From Concussion

NCT01809639

Concussion

COMPLETED PHASE4

Dose Comparison Study of Topiramate in Pediatric Subjects With Basilar/Hemiplegic Migraine

NCT00131443

Basilar Migraine

COMPLETED PHASE2/PHASE3

Effects of Psilocybin in Concussion Headache

NCT03806985

Post-Traumatic Headache

TERMINATED PHASE1

Pediatric Chronic Headache Trial

NCT00389038

Headache

UNKNOWN PHASE3

Metoclopramide for Post Traumatic Headache

NCT03220958

Post-Traumatic Headache

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Concussion Post Syndrome Headaches Posttraumatic Mild Traumatic Brain Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental

10mg capsule once daily for 4 weeks of nortriptyline

Group Type EXPERIMENTAL

Nortriptyline

Intervention Type DRUG

10mg capsule Nortryptyline

Control

10mg capsule once daily for 4 weeks of Thick-It filler

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

10mg capsule Thick-It filler

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nortriptyline

10mg capsule Nortryptyline

Intervention Type DRUG

Placebo

10mg capsule Thick-It filler

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Pamelor

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

13 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes