Trials / Terminated
TerminatedNCT04226365
Pediatric Concussion Outcomes
Treatment for Post-concussive Headache: A Randomized, Placebo-controlled, Double Blinded Trial
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Lancaster General Hospital · Academic / Other
- Sex
- All
- Age
- 13 Years – 21 Years
- Healthy volunteers
- Accepted
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.
Detailed description
Participants are randomly assigned to one of two treatment groups. The experimental group receives standard headache treatment including Tylenol, NSAIDs 2-3x/week, vestibular PT and daily nortriptyline 10mg oral. The control group also receives the standard headache treatment, but will instead be given a placebo, which will look physically identical to the nortriptyline capsule and be comprised of non-active pharmaceutical grade excipient.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nortriptyline | 10mg capsule Nortryptyline |
| DRUG | Placebo | 10mg capsule Thick-It filler |
Timeline
- Start date
- 2020-02-15
- Primary completion
- 2023-05-31
- Completion
- 2023-05-31
- First posted
- 2020-01-13
- Last updated
- 2025-09-10
- Results posted
- 2025-09-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04226365. Inclusion in this directory is not an endorsement.