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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: Clinical Trial Phase 4 study, sponsored by Lancaster General Hospital.
NCT04226365 is a Phase 4 study that was terminated before completion, run by Lancaster General Hospital. The registered enrollment target is 8 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Nortriptyline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2020-02-15 |
| Est. Completion | 2023-05-31 |
| Phase | Phase 4 |
Why NCT04226365 stopped before completion
NCT04226365 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04226365 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04226365's enrollment target sits among peer trials
8 1972nd of 2000 higher than 20 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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