Pediatric Concussion Outcomes (PeCon)
Primary Purpose
Concussion Post Syndrome, Headaches Posttraumatic, Mild Traumatic Brain Injury
Status
Enrolling by invitation
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nortriptyline
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Concussion Post Syndrome focused on measuring concussion, headache, mild TBI, post concussion
Eligibility Criteria
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
Sites / Locations
- Penn Medicine Lancaster General Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental
Control
Arm Description
10mg capsule once daily for 4 weeks of nortriptyline
10mg capsule once daily for 4 weeks of Thick-It filler
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04226365
First Posted
January 9, 2020
Last Updated
August 16, 2022
Sponsor
Lancaster General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04226365
Brief Title
Pediatric Concussion Outcomes
Acronym
PeCon
Official Title
Treatment for Post-concussive Headache: A Randomized, Placebo-controlled, Double Blinded Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 15, 2020 (Actual)
Primary Completion Date
February 2, 2025 (Anticipated)
Study Completion Date
August 2, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lancaster General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion Post Syndrome, Headaches Posttraumatic, Mild Traumatic Brain Injury
Keywords
concussion, headache, mild TBI, post concussion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
10mg capsule once daily for 4 weeks of nortriptyline
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
10mg capsule once daily for 4 weeks of Thick-It filler
Intervention Type
Drug
Intervention Name(s)
Nortriptyline
Other Intervention Name(s)
Pamelor
Intervention Description
10mg capsule Nortryptyline
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
10mg capsule Thick-It filler
Primary Outcome Measure Information:
Title
Post-Concussive Symptom Inventory (PSCI) score
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Moreno, MD
Organizational Affiliation
Lancaster General Health Sports Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura DiPaolo, MD
Organizational Affiliation
Lancaster General Health Sports Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn Medicine Lancaster General Health
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pediatric Concussion Outcomes
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