drugset / Trial / NCT04799015
Dexamethasone for Post Traumatic Headache
Phase 4
Completed
162 enrolled
Montefiore Medical Center
National Center for Advancing Translational Sciences (NCATS) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a randomized study of intravenous metoclopramide + intravenous dexamethasone versus intravenous metoclopramide for patients with acute post-traumatic headache.
Timeline
- Start
- 2021-06-25
- Primary completion
- 2024-11-17
- Completion
- 2024-12-22
Publications
- Background 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.
- Background Evans 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 Shah 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 Patterson 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 Larsen 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 Friedman 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 Orr 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 Bramley 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 Navratilova 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 Kamins 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 Zeng 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 Barlow KM. Post-traumatic headache: An unmet medical need. Headache. 2021 Nov;61(10):1465-1466. doi: 10.1111/head.14241. No abstract available.
- Background May 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.
- Background Headache 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.
- Background Latev 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.
- Background Friedman BW, Solorzano C, Kessler BD, Martorello K, Lutz CL, Feliciano C, Adler N, Moss H, Cain D, Irizarry E. Randomized Trial Comparing Low- vs High-Dose IV Dexamethasone for Patients With Moderate to Severe Migraine. Neurology. 2023 Oct 3;101(14):e1448-e1454. doi: 10.1212/WNL.0000000000207648. Epub 2023 Aug 21.
- Background Ashina H, Diener HC, Tassorelli C, Scher AI, Lipton RB, Pozo-Rosich P, Sinclair AJ, Chong CD, Finkel AG, Ashina M, Schwedt TJ, Dodick DW, Terwindt GM. Guidelines of the International Headache Society for controlled trials of pharmacological preventive treatment for persistent post-traumatic headache attributed to mild traumatic brain injury. Cephalalgia. 2024 Mar;44(3):3331024241234068. doi: 10.1177/03331024241234068.
- Background Diener HC, Tassorelli C, Dodick DW, Silberstein SD, Lipton RB, Ashina M, Becker WJ, Ferrari MD, Goadsby PJ, Pozo-Rosich P, Wang SJ, Mandrekar J; International Headache Society Clinical Trials Standing Committee. Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: Fourth edition. Cephalalgia. 2019 May;39(6):687-710. doi: 10.1177/0333102419828967. Epub 2019 Feb 26.
- Background Chin EY, Nelson LD, Barr WB, McCrory P, McCrea MA. Reliability and Validity of the Sport Concussion Assessment Tool-3 (SCAT3) in High School and Collegiate Athletes. Am J Sports Med. 2016 Sep;44(9):2276-85. doi: 10.1177/0363546516648141. Epub 2016 Jun 8.
- Background Friedman BW, Babbush K, Irizarry E, White D, John Gallagher E. An exploratory study of IV metoclopramide+diphenhydramine for acute post-traumatic headache. Am J Emerg Med. 2018 Feb;36(2):285-289. doi: 10.1016/j.ajem.2017.10.034. Epub 2017 Oct 13.
- Joudi K, Nsenga A, Williams AR, Lee SI, Johnson S, Irizarry E, Friedman BW. IV dexamethasone as adjuvant therapy to metoclopramide for acute posttraumatic headache in the ED: A randomized controlled trial. Headache. 2026 May;66(5):1081-1087. doi: 10.1111/head.70027. Epub 2026 Jan 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 10 mg | Intravenous |
| Background | Metoclopramide | Small molecule | 10 mg | Intravenous |