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NCT04226365 · ClinicalTrials.gov registry record · Phase 4

Pediatric Concussion Outcomes

A Phase 4 study, sponsored by Lancaster General Hospital.

Terminated
Registry status
Phase 4
Development phase
8
Enrollment target

NCT04226365 is a Phase 4 study that was terminated before completion, run by Lancaster General Hospital. The registered enrollment target is 8 participants.

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The verdict

NCT04226365, a Phase 4 study, was terminated before completion, sponsored by Lancaster General Hospital.

TERMINATED
Registry status
Phase 4
Development phase
8 participants
Enrollment target

Study 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.

Interventions

  • DRUG Placebo
  • DRUG Nortriptyline

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2020-02-15
Est. Completion 2023-05-31
Phase Phase 4

Sponsor

Lancaster General Hospital

15 total trials

What the Registry Record Tells You About NCT04226365

The ClinicalTrials.gov registry entry for NCT04226365 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lancaster General Hospital, which has 15 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04226365 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04226365 about?

NCT04226365 is a clinical study titled "Pediatric Concussion Outcomes". 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 t...

What is the current status of trial NCT04226365?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 8 participants. The study started on 2020-02-15. Estimated completion is 2023-05-31.

What interventions are being tested in trial NCT04226365?

The interventions under investigation include: Placebo (DRUG), Nortriptyline (DRUG).

Who is sponsoring clinical trial NCT04226365?

This trial is sponsored by Lancaster General Hospital, which has 15 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.