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Tricyclic Antidepressant

Nortriptyline for Concussion (PeCon Trial)

Phase 4
Waitlist Available
Led By Patrick Moreno, MD
Research Sponsored by Lancaster General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
No loss of consciousness OR loss of consciousness <30 minutes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

PeCon Trial Summary

This trial will test if a medication can help improve concussion symptoms faster than without the medication.

Who is the study for?
This trial is for young people aged 13-21 who've had a concussion with headaches lasting over 4 weeks. They must be in good health, able to take pills, and not on other concussion meds except common painkillers. Those with severe brain injuries, uncontrolled mental illness, pregnancy, or known allergies to the drug can't join.Check my eligibility
What is being tested?
The study tests if Nortriptyline helps reduce headache symptoms faster than a placebo when added to standard treatments. Participants are randomly assigned to either the drug or placebo group and monitored weekly for symptom changes over four weeks.See study design
What are the potential side effects?
Nortriptyline may cause side effects like mood swings, weight gain, dry mouth, dizziness upon standing up quickly (orthostatic hypotension), and could potentially worsen psychiatric conditions.

PeCon Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am generally healthy and recently had a head injury causing headaches within a week.
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I have not lost consciousness or was unconscious for less than 30 minutes.
Select...
I am only taking NSAIDs or acetaminophen for my concussion.
Select...
It has been over 4 weeks since my concussion.
Select...
My headache, head pressure, and neck pain score is over 3.
Select...
I am between 13 and 21 years old.
Select...
I can take pills and will follow the medication schedule.
Select...
I have had headaches for more than 4 weeks after an injury.

PeCon Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post-Concussive Symptom Inventory (PSCI) score

Side effects data

From 2002 Phase 4 trial • 110 Patients • NCT00000378
3%
orthostatic hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sertaline
Nortriptyline

PeCon Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExperimentalExperimental Treatment1 Intervention
10mg capsule once daily for 4 weeks of nortriptyline
Group II: ControlPlacebo Group1 Intervention
10mg capsule once daily for 4 weeks of Thick-It filler
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nortriptyline
FDA approved

Find a Location

Who is running the clinical trial?

Lancaster General HospitalLead Sponsor
22 Previous Clinical Trials
3,784 Total Patients Enrolled
Patrick Moreno, MDPrincipal InvestigatorLancaster General Health Sports Medicine
Laura DiPaolo, MDPrincipal InvestigatorLancaster General Health Sports Medicine

Media Library

Nortriptyline (Tricyclic Antidepressant) Clinical Trial Eligibility Overview. Trial Name: NCT04226365 — Phase 4
Post-Concussion Syndrome Research Study Groups: Experimental, Control
Post-Concussion Syndrome Clinical Trial 2023: Nortriptyline Highlights & Side Effects. Trial Name: NCT04226365 — Phase 4
Nortriptyline (Tricyclic Antidepressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04226365 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you outline what other research efforts have been conducted using Nortriptyline?

"Currently, 2 Nortriptyline trials are in progress. One of those is a Phase 3 experiment. While the majority of the studies occur in Lancaster, Pennsylvania, there are two other sites where testing can be conducted."

Answered by AI

Does this medical study cater to participants aged 65 and above?

"Applicants to this trial should be between 13 and 18 years of age."

Answered by AI

Would I be eligible to join the clinical trial?

"This clinical trial requires that 100 individuals with post-concussion syndrome, aged between 13 and 18 years old, provide a signed informed consent form. Furthermore, the candidates must be in good health as evidenced by medical history; have had recent head trauma meeting ICHD standards and headache symptoms persisting for ≥4 weeks after the incident; possess an overall PCSHE score > 3; participate during week 4 to 12 of their recovery period from concussion; agree to take oral medication prescribed and avoid over-the counter supplements throughout."

Answered by AI

How many participants are actively engaging in this research project?

"This clinical trial has now closed, with the original posting date being February 15th 2020. Last updated August 16th 2022. Alternatively, if you are searching for other studies related to post-concussion syndrome there are 469 trials actively recruiting and 2 studies seeking patients for Nortriptyline treatment."

Answered by AI

Has Nortriptyline garnered the approval of the Federal Drug Administration?

"The safety of Nortriptyline, which has already received FDA approval and is classified as a Phase 4 trial, was rated 3 on the Power team's scale."

Answered by AI

To what illnesses is Nortriptyline routinely prescribed?

"Nortriptyline is regularly utilized to treat irritable bowel syndrome, but it may also prove effective in alleviating postherpetic neuralgia, major depressive disorder symptoms, and orofacial pain."

Answered by AI

Is enrollment in this research endeavor actively open to participants?

"Unfortunately, this trial has since concluded its recruitment phase and is no longer seeking patients. Originally posted on February 15th 2020, the last edit was made on August 16th 2022. If you're looking for other medical studies related to post-concussion syndrome there are currently 469 trials actively recruiting while two clinical trials are also open targeting Nortriptyline as an intervention."

Answered by AI
~2 spots leftby Mar 2025