Post-Traumatic HeadachePhase 4NCT04799015
Dexamethasone for Post Traumatic Headache
A Phase 4 study testing Dexamethasone and Metoclopramide 10mg in people with Post-Traumatic Headache, run by Montefiore Medical Center at 1 site in United States.
Trial summary
This is a randomized study of intravenous metoclopramide + intravenous dexamethasone versus intravenous metoclopramide for patients with acute post-traumatic headache. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Post-Traumatic Headache
- What is being tested?
- Dexamethasone and Metoclopramide 10mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2021to 22 Dec 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Meet International Classification of Headache Disorders (3rd edition) criteria for acute post-traumatic headache as follows:
- Traumatic injury to the head has occurred
- Headache has developed within 7 days of injury to the head
- Headache is not better accounted for by another diagnosis (e.g., migraine or tension-type headache)
- The headache must be rated as moderate or severe in intensity at the time of initial evaluation
Who cannot join
- More than ten days have elapsed since the head trauma
- Headache has already been treated with an anti-dopaminergic medication
- Medication allergies
- Contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of Monoamine oxidase (MAO) inhibitors, and use of anti-rejection transplant medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study of Dexamethasone as Adjuvant Therapy for Acute Post-traumatic Headache
This is a randomized study of intravenous metoclopramide + intravenous dexamethasone versus intravenous metoclopramide for patients with acute post-traumatic headache.
- Conditions
- Post-Traumatic Headache
- Being tested
- Dexamethasone, Metoclopramide 10mg
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Dexamethasone 10mg IV
Metoclopramide 10mgDrug
Metoclopramide 10mg IV
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Dexamethasone 10mg IV + metoclopramide 10mg IV Receives: Drug: Dexamethasone; Drug: Metoclopramide 10mg |
| Placebo | Placebo comparator | Placebo IV + metoclopramide 10mg IV Receives: Drug: Metoclopramide 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Moderate or Severe Headache After Emergency Department (ED) Discharge
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.
Measured: From ED discharge to 48-hours following discharge from the ED, up to 2 days total
Secondary outcomes (4)
Sustained Headache Relief
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.
Measured: 48 hours after administration of study medication
Post Concussive Symptoms
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.
Measured: 48 hours after ED discharge, up to 2 days total
Post Concussive Symptoms
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.
Measured: 7 days after ED discharge, up to 7 days total
Use of Rescue Medication in the ED
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.
Measured: Duration of ED admission, less than 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start25 Jun 2021
- Primary completion17 Nov 2024
- Study completion22 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization occurred in a 1:1 ratio in blocks of four.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Benjamin Friedman, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799015
- Sponsor's protocol ID
- 2020-12625
- Other IDs
- UL1TR001073
- Status last verified
- May 2026
- First submitted
- 11 Mar 2021
- Last updated
- 15 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified dataset will be made available to clinical researchers upon approval of the analytic plan. Requests should be made to the corresponding author.
Publications
Blyth BJ, Bazarian JJ. Traumatic alterations in consciousness: traumatic brain injury. Emerg Med Clin North Am. 2010 Aug;28(3):571-94. doi: 10.1016/j.emc.2010.03.003.
PubMed 20709244Evans RW. The Postconcussion Syndrome and Posttraumatic Headaches in Civilians, Soldiers, and Athletes. Neurol Clin. 2024 May;42(2):341-373. doi: 10.1016/j.ncl.2023.12.001. Epub 2024 Jan 16.
PubMed 38575256Shah R, Das S, Gentile Kruse CF, de Prado BM, Raj N, Evans M, Panigrahi P, Hershey AD, Master CL, Szperka CL, Patterson Gentile C. Patterns of Use and Benefit of Triptans in the Treatment of Acute Headache Worsening in Youth With Post-Traumatic Headache. Pediatr Neurol. 2025 Jun;167:96-102. doi: 10.1016/j.pediatrneurol.2025.03.013. Epub 2025 Mar 27.
PubMed 40252247Patterson Gentile C, Shah R, Irwin SL, Greene K, Szperka CL. Acute and chronic management of posttraumatic headache in children: A systematic review. Headache. 2021 Nov;61(10):1475-1492. doi: 10.1111/head.14236. Epub 2021 Dec 4.
PubMed 34862612Larsen EL, Ashina H, Iljazi A, Al-Khazali HM, Seem K, Ashina M, Ashina S, Schytz HW. Acute and preventive pharmacological treatment of post-traumatic headache: a systematic review. J Headache Pain. 2019 Oct 21;20(1):98. doi: 10.1186/s10194-019-1051-7.
PubMed 31638888Friedman BW, Irizarry E, Cain D, Caradonna A, Minen MT, Solorzano C, Zias E, Zybert D, McGregor M, Bijur PE, Gallagher EJ. Randomized Study of Metoclopramide Plus Diphenhydramine for Acute Posttraumatic Headache. Neurology. 2021 May 4;96(18):e2323-e2331. doi: 10.1212/WNL.0000000000011822. Epub 2021 Mar 24.
PubMed 33762421Orr SL, Friedman BW, Christie S, Minen MT, Bamford C, Kelley NE, Tepper D. Management of Adults With Acute Migraine in the Emergency Department: The American Headache Society Evidence Assessment of Parenteral Pharmacotherapies. Headache. 2016 Jun;56(6):911-40. doi: 10.1111/head.12835.
PubMed 27300483Bramley H, Melinosky C, Silvis M, Ross S. Pediatric posttraumatic headache: two cases using steroids as abortive therapy. Pediatr Emerg Care. 2012 Oct;28(10):1081-4. doi: 10.1097/PEC.0b013e31826ceeeb.
PubMed 23034499Navratilova E, Rau J, Oyarzo J, Tien J, Mackenzie K, Stratton J, Remeniuk B, Schwedt T, Anderson T, Dodick D, Porreca F. CGRP-dependent and independent mechanisms of acute and persistent post-traumatic headache following mild traumatic brain injury in mice. Cephalalgia. 2019 Dec;39(14):1762-1775. doi: 10.1177/0333102419877662. Epub 2019 Sep 24.
PubMed 31550910Kamins J. Models for Treating Post-traumatic Headache. Curr Pain Headache Rep. 2021 Jun 14;25(8):52. doi: 10.1007/s11916-021-00970-3.
PubMed 34125320Zeng Z, Wei L, Zhang H, Chen W, Wang S. The Effect of Dexamethasone on Neuroinflammation and Cerebral Edema in Rats With Traumatic Brain Injury Combined With Seawater Drowning. Cureus. 2024 Mar 1;16(3):e55309. doi: 10.7759/cureus.55309. eCollection 2024 Mar.
PubMed 38559532Barlow KM. Post-traumatic headache: An unmet medical need. Headache. 2021 Nov;61(10):1465-1466. doi: 10.1111/head.14241. No abstract available.
PubMed 34928511May A, Evers S, Goadsby PJ, Leone M, Manzoni GC, Pascual J, Carvalho V, Romoli M, Aleksovska K, Pozo-Rosich P, Jensen RH; European Academy of Neurology Task Force. European Academy of Neurology guidelines on the treatment of cluster headache. Eur J Neurol. 2023 Oct;30(10):2955-2979. doi: 10.1111/ene.15956. Epub 2023 Jul 28.
PubMed 37515405Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
PubMed 29368949Latev A, Friedman BW, Irizarry E, Solorzano C, Restivo A, Chertoff A, Zias E, Gallagher EJ. A Randomized Trial of a Long-Acting Depot Corticosteroid Versus Dexamethasone to Prevent Headache Recurrence Among Patients With Acute Migraine Who Are Discharged From an Emergency Department. Ann Emerg Med. 2019 Feb;73(2):141-149. doi: 10.1016/j.annemergmed.2018.09.028. Epub 2018 Nov 16.
PubMed 30449536
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Dexamethasone as Adjuvant Therapy for Acute Post-traumatic Headache
- ClinicalTrials.gov ID
- NCT04799015
- Acronym / sponsor ID
- 2020-12625
- Conditions
- Post-Traumatic Headache
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 17 Nov 2024 (actual)
- Study completion
- 22 Dec 2024 (actual)
- First posted
- 16 Mar 2021 (actual)
- Results
- Posted 15 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized study of intravenous metoclopramide + intravenous dexamethasone versus intravenous metoclopramide for patients with acute post-traumatic headache.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization occurred in a 1:1 ratio in blocks of four.
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: Dexamethasone, Drug: Metoclopramide 10mgDexamethasone 10mg IV + metoclopramide 10mg IV |
| Placebo | Placebo comparator | Drug: Metoclopramide 10mgPlacebo IV + metoclopramide 10mg IV |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Meet International Classification of Headache Disorders (3rd edition) criteria for acute post-traumatic headache as follows:
- Traumatic injury to the head has occurred
- Headache has developed within 7 days of injury to the head
- Headache is not better accounted for by another diagnosis (e.g., migraine or tension-type headache)
- The headache must be rated as moderate or severe in intensity at the time of initial evaluation
Key exclusion criteria (4 listed)
- More than ten days have elapsed since the head trauma
- Headache has already been treated with an anti-dopaminergic medication
- Medication allergies
- Contra-indications including pheochromocytoma, seizure disorder, Parkinson's disease, use of Monoamine oxidase (MAO) inhibitors, and use of anti-rejection transplant medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneDexamethasone 10mg IV | Drug | Dexamethasone |
| Metoclopramide 10mgMetoclopramide 10mg IV | Drug | Dexamethasone, Placebo |
Primary outcome
Frequency of Moderate or Severe Headache After Emergency Department (ED) Discharge
Time frame: From ED discharge to 48-hours following discharge from the ED, up to 2 days total
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.
4 secondary outcomes
Sustained Headache Relief
Time frame: 48 hours after administration of study medication
Post Concussive Symptoms
Time frame: 48 hours after ED discharge, up to 2 days total
Post Concussive Symptoms
Time frame: 7 days after ED discharge, up to 7 days total
Use of Rescue Medication in the ED
Time frame: Duration of ED admission, less than 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20709244Blyth BJ, Bazarian JJ. Traumatic alterations in consciousness: traumatic brain injury. Emerg Med Clin North Am. 2010 Aug;28(3):571-94. doi: 10.1016/j.emc.2010.03.003.
- Background: PubMed 38575256Evans RW. The Postconcussion Syndrome and Posttraumatic Headaches in Civilians, Soldiers, and Athletes. Neurol Clin. 2024 May;42(2):341-373. doi: 10.1016/j.ncl.2023.12.001. Epub 2024 Jan 16.
- Background: PubMed 40252247Shah R, Das S, Gentile Kruse CF, de Prado BM, Raj N, Evans M, Panigrahi P, Hershey AD, Master CL, Szperka CL, Patterson Gentile C. Patterns of Use and Benefit of Triptans in the Treatment of Acute Headache Worsening in Youth With Post-Traumatic Headache. Pediatr Neurol. 2025 Jun;167:96-102. doi: 10.1016/j.pediatrneurol.2025.03.013. Epub 2025 Mar 27.
- Background: PubMed 34862612Patterson Gentile C, Shah R, Irwin SL, Greene K, Szperka CL. Acute and chronic management of posttraumatic headache in children: A systematic review. Headache. 2021 Nov;61(10):1475-1492. doi: 10.1111/head.14236. Epub 2021 Dec 4.
- Background: PubMed 31638888Larsen EL, Ashina H, Iljazi A, Al-Khazali HM, Seem K, Ashina M, Ashina S, Schytz HW. Acute and preventive pharmacological treatment of post-traumatic headache: a systematic review. J Headache Pain. 2019 Oct 21;20(1):98. doi: 10.1186/s10194-019-1051-7.
- Background: PubMed 33762421Friedman BW, Irizarry E, Cain D, Caradonna A, Minen MT, Solorzano C, Zias E, Zybert D, McGregor M, Bijur PE, Gallagher EJ. Randomized Study of Metoclopramide Plus Diphenhydramine for Acute Posttraumatic Headache. Neurology. 2021 May 4;96(18):e2323-e2331. doi: 10.1212/WNL.0000000000011822. Epub 2021 Mar 24.
- Background: PubMed 27300483Orr SL, Friedman BW, Christie S, Minen MT, Bamford C, Kelley NE, Tepper D. Management of Adults With Acute Migraine in the Emergency Department: The American Headache Society Evidence Assessment of Parenteral Pharmacotherapies. Headache. 2016 Jun;56(6):911-40. doi: 10.1111/head.12835.
- Background: PubMed 23034499Bramley H, Melinosky C, Silvis M, Ross S. Pediatric posttraumatic headache: two cases using steroids as abortive therapy. Pediatr Emerg Care. 2012 Oct;28(10):1081-4. doi: 10.1097/PEC.0b013e31826ceeeb.
- Background: PubMed 31550910Navratilova E, Rau J, Oyarzo J, Tien J, Mackenzie K, Stratton J, Remeniuk B, Schwedt T, Anderson T, Dodick D, Porreca F. CGRP-dependent and independent mechanisms of acute and persistent post-traumatic headache following mild traumatic brain injury in mice. Cephalalgia. 2019 Dec;39(14):1762-1775. doi: 10.1177/0333102419877662. Epub 2019 Sep 24.
- Background: PubMed 34125320Kamins J. Models for Treating Post-traumatic Headache. Curr Pain Headache Rep. 2021 Jun 14;25(8):52. doi: 10.1007/s11916-021-00970-3.
- Background: PubMed 38559532Zeng Z, Wei L, Zhang H, Chen W, Wang S. The Effect of Dexamethasone on Neuroinflammation and Cerebral Edema in Rats With Traumatic Brain Injury Combined With Seawater Drowning. Cureus. 2024 Mar 1;16(3):e55309. doi: 10.7759/cureus.55309. eCollection 2024 Mar.
- Background: PubMed 34928511Barlow KM. Post-traumatic headache: An unmet medical need. Headache. 2021 Nov;61(10):1465-1466. doi: 10.1111/head.14241. No abstract available.
- Individual participant dataSharing planned: Yes. The de-identified dataset will be made available to clinical researchers upon approval of the analytic plan. Requests should be made to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Friedman, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone and Metoclopramide 10mg in people with Post-Traumatic Headache, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Moderate or Severe Headache After Emergency Department (ED) Discharge (time frame: From ED discharge to 48-hours following discharge from the ED, up to 2 days total). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04799015, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.