Nortriptyline for Concussion
(PeCon Trial)
Trial Summary
What is the purpose of this trial?
This trial tests whether nortriptyline can help people with headaches after a concussion. Participants will receive nortriptyline along with standard headache treatments. The goal is to see if nortriptyline reduces headache symptoms faster by balancing brain chemicals. Nortriptyline has been tested previously for migraine prevention, but it was not effective when used alone.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot be on any medication for concussion other than NSAIDs or acetaminophen.
Is the drug nortriptyline effective for treating symptoms after a concussion?
Is nortriptyline generally safe for humans?
Nortriptyline has been studied in both adolescents and elderly people for depression, and while it did not show significant anticholinergic side effects (like dry mouth or blurred vision) in adolescents, it did affect memory performance in elderly individuals. A study on children and adolescents also looked at heart-related effects, but specific safety outcomes were not detailed in the provided abstracts.56789
How does the drug nortriptyline differ from other treatments for concussion?
Nortriptyline is unique for concussion treatment as it is primarily a tricyclic antidepressant, typically used for depression and other conditions like tinnitus and Parkinson's disease-related depression. Its use in concussion is novel, as there are no standard treatments specifically targeting concussion symptoms with this mechanism of action.2561011
Research Team
Patrick Moreno, MD
Principal Investigator
Lancaster General Health Sports Medicine
Laura DiPaolo, MD
Principal Investigator
Lancaster General Health Sports Medicine
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either nortriptyline or placebo daily for 4 weeks, along with standard headache treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Nortriptyline
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lancaster General Hospital
Lead Sponsor