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Nortriptyline for Concussion (PeCon Trial)
PeCon Trial Summary
This trial will test if a medication can help improve concussion symptoms faster than without the medication.
PeCon Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPeCon Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2002 Phase 4 trial • 110 Patients • NCT00000378PeCon Trial Design
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Who is running the clinical trial?
Media Library
- I am only taking NSAIDs or acetaminophen for my concussion.It has been over 4 weeks since my concussion.My headache, head pressure, and neck pain score is over 3.You have any recent abnormal findings on a CT scan.I have a history of Brugada syndrome.I have specific nerve or brain function issues after an injury.You are currently thinking about harming yourself, as assessed in a screening questionnaire.I am between 13 and 21 years old.I can take pills and will follow the medication schedule.I have not lost consciousness or was unconscious for less than 30 minutes.You are allergic to nortriptyline.I am generally healthy and recently had a head injury causing headaches within a week.I do not have an unmanaged mental health condition.I have a history of seizures or a serious brain injury.I have had headaches for more than 4 weeks after an injury.You tested positive for COVID-19 in the last 14 days.
- Group 1: Experimental
- Group 2: Control
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
Does this medical study cater to participants aged 65 and above?
"Applicants to this trial should be between 13 and 18 years of age."
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."
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."
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."
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."
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."
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