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The study was stopped prematurely due to a low enrollment rate.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | 10mg capsule once daily for 4 weeks of nortriptyline |
|
| Control | Placebo Comparator | 10mg capsule once daily for 4 weeks of Thick-It filler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nortriptyline | Drug | 10mg capsule Nortryptyline |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-Concussive Symptom Inventory (PSCI) Score | 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. | 4 weeks |
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Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Moreno, MD | Lancaster General Health Sports Medicine | Principal Investigator |
| Laura DiPaolo, MD | Lancaster General Health Sports Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn Medicine Lancaster General Health | Lancaster | Pennsylvania | 17602 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25670632 | Background | Choe MC, Blume HK. Pediatric Posttraumatic Headache: A Review. J Child Neurol. 2016 Jan;31(1):76-85. doi: 10.1177/0883073814568152. Epub 2015 Feb 10. | |
| 27017019 | Background | Kacperski J, Hung R, Blume HK. Pediatric Posttraumatic Headache. Semin Pediatr Neurol. 2016 Feb;23(1):27-34. doi: 10.1016/j.spen.2015.08.005. Epub 2015 Aug 19. |
| Label | URL |
|---|---|
| Sport concussion assessment tool - 5th edition | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | 10mg capsule once daily for 4 weeks of nortriptyline Nortriptyline: 10mg capsule Nortryptyline |
| FG001 | Control | 10mg capsule once daily for 4 weeks of Thick-It filler Placebo: 10mg capsule Thick-It filler |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | 10mg capsule once daily for 4 weeks of nortriptyline Nortriptyline: 10mg capsule Nortryptyline |
| BG001 | Control | 10mg capsule once daily for 4 weeks of Thick-It filler Placebo: 10mg capsule Thick-It filler |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-Concussive Symptom Inventory (PSCI) Score | 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. | The trial was terminated before the outcome measure data were collected. | Posted | 4 weeks |
|
39 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental | 10mg capsule once daily for 4 weeks of nortriptyline Nortriptyline: 10mg capsule Nortryptyline |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache/Migraine | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Halle Becker, MPH, Research Project Manager | Penn Medicine / Lancaster General Hospital | 7175441777 | Halle.Becker@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 31, 2023 | Jan 27, 2025 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: English Version | Nov 14, 2023 | Jan 27, 2025 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D038223 | Post-Concussion Syndrome |
| D051298 | Post-Traumatic Headache |
| D001924 | Brain Concussion |
| D006261 | Headache |
| ID | Term |
|---|---|
| D016489 | Head Injuries, Closed |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D009661 | Nortriptyline |
| ID | Term |
|---|---|
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Placebo | Drug | 10mg capsule Thick-It filler |
|
| 28446457 | Background | McCrory P, Meeuwisse W, Dvorak J, Aubry M, Bailes J, Broglio S, Cantu RC, Cassidy D, Echemendia RJ, Castellani RJ, Davis GA, Ellenbogen R, Emery C, Engebretsen L, Feddermann-Demont N, Giza CC, Guskiewicz KM, Herring S, Iverson GL, Johnston KM, Kissick J, Kutcher J, Leddy JJ, Maddocks D, Makdissi M, Manley GT, McCrea M, Meehan WP, Nagahiro S, Patricios J, Putukian M, Schneider KJ, Sills A, Tator CH, Turner M, Vos PE. Consensus statement on concussion in sport-the 5th international conference on concussion in sport held in Berlin, October 2016. Br J Sports Med. 2017 Jun;51(11):838-847. doi: 10.1136/bjsports-2017-097699. Epub 2017 Apr 26. No abstract available. |
| 28483928 | Background | Makdissi M, Schneider KJ, Feddermann-Demont N, Guskiewicz KM, Hinds S, Leddy JJ, McCrea M, Turner M, Johnston KM. Approach to investigation and treatment of persistent symptoms following sport-related concussion: a systematic review. Br J Sports Med. 2017 Jun;51(12):958-968. doi: 10.1136/bjsports-2016-097470. Epub 2017 May 8. |
| 28422893 | Background | Bernard CO, Ponsford JL, McKinlay A, McKenzie D, Krieser D. Do Concussive Symptoms Really Resolve in Young Children? J Head Trauma Rehabil. 2017 Nov/Dec;32(6):413-424. doi: 10.1097/HTR.0000000000000298. |
| 23560811 | Background | Kuczynski A, Crawford S, Bodell L, Dewey D, Barlow KM. Characteristics of post-traumatic headaches in children following mild traumatic brain injury and their response to treatment: a prospective cohort. Dev Med Child Neurol. 2013 Jul;55(7):636-41. doi: 10.1111/dmcn.12152. Epub 2013 Apr 5. |
| 11869927 | Background | Johnson JG, Harris ES, Spitzer RL, Williams JB. The patient health questionnaire for adolescents: validation of an instrument for the assessment of mental disorders among adolescent primary care patients. J Adolesc Health. 2002 Mar;30(3):196-204. doi: 10.1016/s1054-139x(01)00333-0. |
| Pamelor \[package insert\]. Hazelwood, MO: Mallinckrodt Inc; 2019. | View source |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| 0 |
| 4 |
| 0 |
| 4 |
| 2 |
| 4 |
| EG001 | Control | 10mg capsule once daily for 4 weeks of Thick-It filler Placebo: 10mg capsule Thick-It filler | 0 | 4 | 0 | 4 | 1 | 4 |
| Sever's Apophysitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |