Trial Outcomes & Findings for Pediatric Concussion Outcomes (NCT NCT04226365)
NCT ID: NCT04226365
Last Updated: 2025-09-10
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
8 participants
Primary outcome timeframe
4 weeks
Results posted on
2025-09-10
Participant Flow
Participant milestones
| Measure |
Experimental
10mg capsule once daily for 4 weeks of nortriptyline
Nortriptyline: 10mg capsule Nortryptyline
|
Control
10mg capsule once daily for 4 weeks of Thick-It filler
Placebo: 10mg capsule Thick-It filler
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pediatric Concussion Outcomes
Baseline characteristics by cohort
| Measure |
Experimental
n=4 Participants
10mg capsule once daily for 4 weeks of nortriptyline
Nortriptyline: 10mg capsule Nortryptyline
|
Control
n=4 Participants
10mg capsule once daily for 4 weeks of Thick-It filler
Placebo: 10mg capsule Thick-It filler
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
14.5 years
STANDARD_DEVIATION 2 • n=5 Participants
|
14.7 years
STANDARD_DEVIATION 1 • n=7 Participants
|
14.6 years
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: The trial was terminated before the outcome measure data were collected.
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.
Outcome measures
Outcome data not reported
Adverse Events
Experimental
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental
n=4 participants at risk
10mg capsule once daily for 4 weeks of nortriptyline
Nortriptyline: 10mg capsule Nortryptyline
|
Control
n=4 participants at risk
10mg capsule once daily for 4 weeks of Thick-It filler
Placebo: 10mg capsule Thick-It filler
|
|---|---|---|
|
Nervous system disorders
Headache/Migraine
|
25.0%
1/4 • Number of events 3 • 39 months
|
25.0%
1/4 • Number of events 1 • 39 months
|
|
Musculoskeletal and connective tissue disorders
Sever's Apophysitis
|
25.0%
1/4 • Number of events 1 • 39 months
|
0.00%
0/4 • 39 months
|
Additional Information
Halle Becker, MPH, Research Project Manager
Penn Medicine / Lancaster General Hospital
Phone: 7175441777
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place