Trial · NCT04226365
Pediatric Concussion Outcomes
NCT04226365, Phase 4, Terminated, Lancaster General Hospital; results first posted 2025-09-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pediatric Concussion Outcomes. Trials, record NCT04226365. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04226365
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pediatric Concussion Outcomes
- NCT number
- NCT04226365
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 8 participants, actual
- Lead sponsor
- Lancaster General Hospital
- Conditions
- Concussion Post Syndrome, Headaches Posttraumatic, Mild Traumatic Brain Injury
- Interventions
- Nortriptyline, Placebo
- First posted
- 2020-01-13
- Last updated
- 2025-09-10
- Results first posted
- 2025-09-10
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Post-Concussive Symptom Inventory (PSCI) Score | 4 weeks | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Post-Concussive Symptom Inventory (PSCI) Score | 4 weeks | The trial was terminated before the outcome measure data were collected. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Experimental | 4 | |
| Overall Study | STARTED | Control | 4 | |
| Overall Study | COMPLETED | Experimental | 4 | |
| Overall Study | COMPLETED | Control | 4 | |
| Overall Study | NOT COMPLETED | Experimental | 0 | |
| Overall Study | NOT COMPLETED | Control | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache/Migraine | Nervous system disorders | Experimental | 1 | 4 | 3 |
| other | Headache/Migraine | Nervous system disorders | Control | 1 | 4 | 1 |
| other | Sever's Apophysitis | Musculoskeletal and connective tissue disorders | Experimental | 1 | 4 | 1 |
| other | Sever's Apophysitis | Musculoskeletal and connective tissue disorders | Control | 0 | 4 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental | 0 | 4 |
| Total, all-cause mortality | Control | 0 | 4 |
| Total, other adverse events | Experimental | 2 | 4 |
| Total, other adverse events | Control | 1 | 4 |
| Total, serious adverse events | Experimental | 0 | 4 |
| Total, serious adverse events | Control | 0 | 4 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Experimental vs Control: deaths from any cause | Trial comparisons |
| Experimental vs Control: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04226365
GET https://conductscience.org/api/trials/v1/NCT04226365/registered