Trial Outcomes & Findings for Dexamethasone for Post Traumatic Headache (NCT NCT04799015)

Last Updated: 2026-05-15

Results Overview

Headache intensity will be rated based on the International Headache Society (IHS) 4-point scale. Using this scale participants will verbalize whether their headache intensity is "Severe," "Moderate," "Mild," or "None." The percentage of patients reporting a headache intensity level of either "Moderate" or "Severe" will be grouped and summarized by study arm. The number/percentage of patients reporting a headache intensity level of "Mild" or "None" will also be grouped and summarized by study arm. Between-group difference along with 95% confidence intervals will be reported. Patients who use an analgesic or abortive headache medication during the 48-hour period will be considered an outcome failure.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

162 participants

Primary outcome timeframe

From ED discharge to 48-hours following discharge from the ED, up to 2 days total

Results posted on

2026-05-15

Participant Flow

The study was conducted in two emergency departments in the Bronx, New York. Enrollment commenced in June 2021 and completed in November 2024.

2,220 patients were screened for participation and 162 were enrolled as research participants. Despite repeated attempts, 8 study participants within each arm were unable to be contacted after discharge from the ED.

Participant milestones

Participant milestones
Measure	Dexamethasone Dexamethasone 10mg IV + metoclopramide 10mg IV Dexamethasone: Dexamethasone 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV	Placebo Placebo IV + metoclopramide 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV
Overall Study STARTED	81	81
Overall Study COMPLETED	73	73
Overall Study NOT COMPLETED	8	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Dexamethasone Dexamethasone 10mg IV + metoclopramide 10mg IV Dexamethasone: Dexamethasone 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV	Placebo Placebo IV + metoclopramide 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV
Overall Study Lost to Follow-up	8	8

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexamethasone n=81 Participants Dexamethasone 10mg IV + metoclopramide 10mg IV Dexamethasone: Dexamethasone 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV	Placebo n=81 Participants Placebo IV + metoclopramide 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV	Total n=162 Participants Total of all reporting groups
Age, Continuous	47.0 years STANDARD_DEVIATION 17.4 • n=81 Participants	41.8 years STANDARD_DEVIATION 13.8 • n=81 Participants	44.4 years STANDARD_DEVIATION 15.9 • n=162 Participants
Sex: Female, Male Female	63 Participants n=81 Participants	60 Participants n=81 Participants	123 Participants n=162 Participants
Sex: Female, Male Male	18 Participants n=81 Participants	21 Participants n=81 Participants	39 Participants n=162 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	81 participants n=81 Participants	81 participants n=81 Participants	162 participants n=162 Participants
Headache Duration	18 hours n=81 Participants	21 hours n=81 Participants	19 hours n=162 Participants
Baseline Headache Intensity Moderate	35 Participants n=81 Participants	26 Participants n=81 Participants	61 Participants n=162 Participants
Baseline Headache Intensity Severe	46 Participants n=81 Participants	55 Participants n=81 Participants	101 Participants n=162 Participants
Loss of Consciousness No	60 Participants n=81 Participants	53 Participants n=81 Participants	113 Participants n=162 Participants
Mechanism of Injury Assault	11 Participants n=81 Participants	14 Participants n=81 Participants	25 Participants n=162 Participants
Mechanism of Injury Motor vehicle collision	7 Participants n=81 Participants	7 Participants n=81 Participants	14 Participants n=162 Participants
Mechanism of Injury Fall	36 Participants n=81 Participants	35 Participants n=81 Participants	71 Participants n=162 Participants
Mechanism of Injury Bumped into object	20 Participants n=81 Participants	15 Participants n=81 Participants	35 Participants n=162 Participants
Mechanism of Injury Object fell onto patient	6 Participants n=81 Participants	8 Participants n=81 Participants	14 Participants n=162 Participants
Mechanism of Injury Other/Unknown	1 Participants n=81 Participants	2 Participants n=81 Participants	3 Participants n=162 Participants
Loss of Consciousness Yes	9 Participants n=81 Participants	20 Participants n=81 Participants	29 Participants n=162 Participants
Loss of Consciousness Not sure	12 Participants n=81 Participants	8 Participants n=81 Participants	20 Participants n=162 Participants
Post Concussive Symptoms	33 score on a scale n=80 Participants • Post-concussive symptom data was not available from 1 of the patients in the Dexamethasone arm.	38 score on a scale n=81 Participants • Post-concussive symptom data was not available from 1 of the patients in the Dexamethasone arm.	36 score on a scale n=161 Participants • Post-concussive symptom data was not available from 1 of the patients in the Dexamethasone arm.

PRIMARY outcome

Timeframe: From ED discharge to 48-hours following discharge from the ED, up to 2 days total

Population: Data were unable to be collected from 8 patients in the Dexamethasone arm and 8 patients in the Placebo arm. Outcome failures in the description were not excluded from analysis. This was registered inadvertently as this was not part of the study plan and is inconsistent with the IRB approved protocol.

Outcome measures

Outcome measures
Measure	Dexamethasone n=73 Participants Dexamethasone 10mg IV + metoclopramide 10mg IV Dexamethasone: Dexamethasone 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV	Placebo n=73 Participants Placebo IV + metoclopramide 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV
Frequency of Moderate or Severe Headache After Emergency Department (ED) Discharge Moderate or Severe Symptoms or Use of Analgesic Medication	42 Participants	44 Participants
Frequency of Moderate or Severe Headache After Emergency Department (ED) Discharge Mild or None	31 Participants	29 Participants

SECONDARY outcome

Timeframe: 48 hours after administration of study medication

Population: Data were unable to be collected from 4 patients in the Dexamethasone arm and 2 patients in the Placebo arm.

Sustained headache pain relief will be defined as the number of patients achieving a headache intensity of "mild" or "none" after administration of study medication and who maintain that level for 48 hours without the use of rescue medication. The percentage of patients reporting a headache intensity level of either "mild" or "none" will be considered to have achieved and maintained sustained headache relief and will be summarized by study arm.

Outcome measures

Outcome measures
Measure	Dexamethasone n=77 Participants Dexamethasone 10mg IV + metoclopramide 10mg IV Dexamethasone: Dexamethasone 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV	Placebo n=79 Participants Placebo IV + metoclopramide 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV
Sustained Headache Relief Yes	10 Participants	12 Participants
Sustained Headache Relief No	67 Participants	67 Participants

SECONDARY outcome

Timeframe: 48 hours after ED discharge, up to 2 days total

Population: Post-concussive symptom data was not collected at 48 hours post-ED discharge due to an error in the data collection form. Specifically, the form did not query patients for symptoms during this collection interval and, consequently, no PCSS scores are available to report at the 48 hours post-discharge timepoint. While the opportunity to collect data at this timepoint was missed, PCSS scores are available at 1 hour and 7 days post-ED discharge

Post concussive symptoms at 48 hours will be assessed using the Sport Concussion Assessment Tool (SCAT) Post Concussion Symptom Scale (PCSS). Using the validated SCAT PCSS patients rate the severity of 22 concussive symptoms on a 7-point Likert scale ranging from 0 ("none") to 6 ("severe") yielding an overall possible scoring range of 0-132. Higher SCAT PCSS scores are indicative greater severity of post-concussive symptoms. Results will be summarized by study arm using basic descriptive statistics.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days after ED discharge, up to 7 days total

Population: Post-concussive symptom data was unable to be collected from 2 patients in the Dexamethasone arm and from 1 patient in the Placebo arm.

Post concussive symptoms at 7 days will be assessed using the Sport Concussion Assessment Tool (SCAT) Post Concussion Symptom Scale (PCSS). Using the validated SCAT PCSS patients rate the severity of 22 concussive symptoms on a 7-point Likert scale ranging from 0 ("none") to 6 ("severe") yielding an overall possible scoring range of 0-132. Higher SCAT PCSS scores are indicative of greater severity of post-concussive symptoms. Results will be summarized by study arm using basic descriptive statistics.

Outcome measures

Outcome measures
Measure	Dexamethasone n=71 Participants Dexamethasone 10mg IV + metoclopramide 10mg IV Dexamethasone: Dexamethasone 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV	Placebo n=72 Participants Placebo IV + metoclopramide 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV
Post Concussive Symptoms	6 score on a scale Interval 0.0 to 20.0	4 score on a scale Interval 0.0 to 13.0

SECONDARY outcome

Timeframe: Duration of ED admission, less than 1 day

Use of rescue medication will be defined as the number of patients administered any analgesic medication or headache abortive medication while in the ED. The number of patients who used rescue medication while in the ED will be summarized by study arm.

Outcome measures

Outcome measures
Measure	Dexamethasone n=81 Participants Dexamethasone 10mg IV + metoclopramide 10mg IV Dexamethasone: Dexamethasone 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV	Placebo n=81 Participants Placebo IV + metoclopramide 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV
Use of Rescue Medication in the ED Yes	12 Participants	15 Participants
Use of Rescue Medication in the ED No	69 Participants	66 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 1 week after ED discharge, up to 7 days total

Population: Data were unable to be collected from 1 patient in the Dexamethasone arm and 1 patient in the Placebo arm.

The mean number of days with headache during the 1-week period following discharge will be summarized by study arm using basic descriptive statistics

Outcome measures

Outcome measures
Measure	Dexamethasone n=72 Participants Dexamethasone 10mg IV + metoclopramide 10mg IV Dexamethasone: Dexamethasone 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV	Placebo n=72 Participants Placebo IV + metoclopramide 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV
Number of Days With Headache During the Week After ED Discharge	3.0 days Standard Deviation 2.8	2.9 days Standard Deviation 2.6

POST_HOC outcome

Timeframe: 1 hour after administration of study medication

Population: Data from 1 patient in the Dexamethasone arm was unavailable.

Headache pain intensity was assessed one hour after administration of study medication in the ED. Participants were asked to quantify their headache using the following descriptors: "Severe", "Moderate", "Mild" or "None". No other cues/descriptions were provided. Results are summarized by study arm.

Outcome measures

Outcome measures
Measure	Dexamethasone n=80 Participants Dexamethasone 10mg IV + metoclopramide 10mg IV Dexamethasone: Dexamethasone 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV	Placebo n=81 Participants Placebo IV + metoclopramide 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV
Headache Pain Intensity None	17 Participants	19 Participants
Headache Pain Intensity Mild	40 Participants	30 Participants
Headache Pain Intensity Moderate	20 Participants	25 Participants
Headache Pain Intensity Severe	3 Participants	7 Participants

POST_HOC outcome

Timeframe: Up to 48 hours following discharge from the ED, up to 2 days total

Population: Data were unable to be collected from 1 patient in the Dexamethasone and 1 patient in the Placebo arm.

Use of rescue medication post-discharge will be defined as the number of patients administered any analgesic medication or headache abortive medication during the 48-hour period following discharge. The number of patients who used rescue medication during this period are summarized by study arm.

Outcome measures

Outcome measures
Measure	Dexamethasone n=72 Participants Dexamethasone 10mg IV + metoclopramide 10mg IV Dexamethasone: Dexamethasone 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV	Placebo n=72 Participants Placebo IV + metoclopramide 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV
Use of Rescue Medication Post-discharge Yes	36 Participants	40 Participants
Use of Rescue Medication Post-discharge No	36 Participants	32 Participants

POST_HOC outcome

Timeframe: 48 hours following medication administration

Patient assessment of blinding was determined by surveying the patients as to whether they believed they received actual study drug medication, placebo, or were not sure whether they received actual study drug medication or placebo. Categorical variables were summarized by study arm.

Outcome measures

Outcome measures
Measure	Dexamethasone n=73 Participants Dexamethasone 10mg IV + metoclopramide 10mg IV Dexamethasone: Dexamethasone 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV	Placebo n=73 Participants Placebo IV + metoclopramide 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV
Assessment of Blinding Believed they received actual study drug medication	43 Participants	35 Participants
Assessment of Blinding Believed they received placebo	1 Participants	6 Participants
Assessment of Blinding Not sure	29 Participants	32 Participants

POST_HOC outcome

Timeframe: 1 hour

Population: Post-concussive symptom data were unable to be collected from 4 patients in the Dexamethasone arm and 3 patients in the Placebo arm

Post concussive symptoms at 1 hour will be assessed using the Sport Concussion Assessment Tool (SCAT) Post Concussion Symptom Scale (PCSS). Using the validated SCAT PCSS patients rate the severity of 22 concussive symptoms on a 7-point Likert scale ranging from 0 ("none") to 6 ("severe") yielding an overall possible scoring range of 0-132. Higher SCAT PCSS scores are indicative of greater severity of post-concussive symptoms. Results will be summarized by study arm using basic descriptive statistics.

Outcome measures

Outcome measures
Measure	Dexamethasone n=77 Participants Dexamethasone 10mg IV + metoclopramide 10mg IV Dexamethasone: Dexamethasone 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV	Placebo n=78 Participants Placebo IV + metoclopramide 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV
Post Concussive Symptoms	8 score on a scale Interval 3.0 to 18.0	9 score on a scale Interval 2.0 to 27.0

Adverse Events

Dexamethasone

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dexamethasone n=81 participants at risk Dexamethasone 10mg IV + metoclopramide 10mg IV Dexamethasone: Dexamethasone 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV	Placebo n=81 participants at risk Placebo IV + metoclopramide 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV
Psychiatric disorders Irritability	0.00% 0/81 • Hourly in the ED and during the 48-hour follow-up period following the treatment intervention, up to 2 days total. Adverse events were elicited using the simple dichotomous question, "Did you experience any new symptoms after receiving the study medications?", followed by an open-ended question "Please tell us about these symptoms."	1.2% 1/81 • Hourly in the ED and during the 48-hour follow-up period following the treatment intervention, up to 2 days total. Adverse events were elicited using the simple dichotomous question, "Did you experience any new symptoms after receiving the study medications?", followed by an open-ended question "Please tell us about these symptoms."
Vascular disorders Flushing	0.00% 0/81 • Hourly in the ED and during the 48-hour follow-up period following the treatment intervention, up to 2 days total. Adverse events were elicited using the simple dichotomous question, "Did you experience any new symptoms after receiving the study medications?", followed by an open-ended question "Please tell us about these symptoms."	1.2% 1/81 • Hourly in the ED and during the 48-hour follow-up period following the treatment intervention, up to 2 days total. Adverse events were elicited using the simple dichotomous question, "Did you experience any new symptoms after receiving the study medications?", followed by an open-ended question "Please tell us about these symptoms."
Nervous system disorders Dizziness	0.00% 0/81 • Hourly in the ED and during the 48-hour follow-up period following the treatment intervention, up to 2 days total. Adverse events were elicited using the simple dichotomous question, "Did you experience any new symptoms after receiving the study medications?", followed by an open-ended question "Please tell us about these symptoms."	1.2% 1/81 • Hourly in the ED and during the 48-hour follow-up period following the treatment intervention, up to 2 days total. Adverse events were elicited using the simple dichotomous question, "Did you experience any new symptoms after receiving the study medications?", followed by an open-ended question "Please tell us about these symptoms."
Nervous system disorders Somnolence	7.4% 6/81 • Hourly in the ED and during the 48-hour follow-up period following the treatment intervention, up to 2 days total. Adverse events were elicited using the simple dichotomous question, "Did you experience any new symptoms after receiving the study medications?", followed by an open-ended question "Please tell us about these symptoms."	4.9% 4/81 • Hourly in the ED and during the 48-hour follow-up period following the treatment intervention, up to 2 days total. Adverse events were elicited using the simple dichotomous question, "Did you experience any new symptoms after receiving the study medications?", followed by an open-ended question "Please tell us about these symptoms."
Gastrointestinal disorders Nausea	1.2% 1/81 • Hourly in the ED and during the 48-hour follow-up period following the treatment intervention, up to 2 days total. Adverse events were elicited using the simple dichotomous question, "Did you experience any new symptoms after receiving the study medications?", followed by an open-ended question "Please tell us about these symptoms."	1.2% 1/81 • Hourly in the ED and during the 48-hour follow-up period following the treatment intervention, up to 2 days total. Adverse events were elicited using the simple dichotomous question, "Did you experience any new symptoms after receiving the study medications?", followed by an open-ended question "Please tell us about these symptoms."
Nervous system disorders Akathisia	2.5% 2/81 • Hourly in the ED and during the 48-hour follow-up period following the treatment intervention, up to 2 days total. Adverse events were elicited using the simple dichotomous question, "Did you experience any new symptoms after receiving the study medications?", followed by an open-ended question "Please tell us about these symptoms."	1.2% 1/81 • Hourly in the ED and during the 48-hour follow-up period following the treatment intervention, up to 2 days total. Adverse events were elicited using the simple dichotomous question, "Did you experience any new symptoms after receiving the study medications?", followed by an open-ended question "Please tell us about these symptoms."
Eye disorders Blurred Vision	1.2% 1/81 • Hourly in the ED and during the 48-hour follow-up period following the treatment intervention, up to 2 days total. Adverse events were elicited using the simple dichotomous question, "Did you experience any new symptoms after receiving the study medications?", followed by an open-ended question "Please tell us about these symptoms."	0.00% 0/81 • Hourly in the ED and during the 48-hour follow-up period following the treatment intervention, up to 2 days total. Adverse events were elicited using the simple dichotomous question, "Did you experience any new symptoms after receiving the study medications?", followed by an open-ended question "Please tell us about these symptoms."
General disorders Chills	1.2% 1/81 • Hourly in the ED and during the 48-hour follow-up period following the treatment intervention, up to 2 days total. Adverse events were elicited using the simple dichotomous question, "Did you experience any new symptoms after receiving the study medications?", followed by an open-ended question "Please tell us about these symptoms."	0.00% 0/81 • Hourly in the ED and during the 48-hour follow-up period following the treatment intervention, up to 2 days total. Adverse events were elicited using the simple dichotomous question, "Did you experience any new symptoms after receiving the study medications?", followed by an open-ended question "Please tell us about these symptoms."
Nervous system disorders Headache	1.2% 1/81 • Hourly in the ED and during the 48-hour follow-up period following the treatment intervention, up to 2 days total. Adverse events were elicited using the simple dichotomous question, "Did you experience any new symptoms after receiving the study medications?", followed by an open-ended question "Please tell us about these symptoms."	0.00% 0/81 • Hourly in the ED and during the 48-hour follow-up period following the treatment intervention, up to 2 days total. Adverse events were elicited using the simple dichotomous question, "Did you experience any new symptoms after receiving the study medications?", followed by an open-ended question "Please tell us about these symptoms."

Additional Information

Dr. Benjamin Friedman

Montefiore Medical Center

Phone: 718-920-6626

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place