Assessment of the Efficacy of Medrol Dose Pack for Acute Post-Concussive Headaches

NCT04685772 | Recruiting FDA Drug

• 1 other identifier: 20-1092
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This novel pilot project will assess the effectiveness of corticosteroids in treatment of acute post-concussion headache. The investigators hypothesize that the use of corticosteroids will cause significant headache reduction in frequency and/or intensity than individuals who undergo the current standard of care. Additionally, the investigators hypothesize that corticosteroid use will lead to a reduction in other somatic symptoms including vestibular symptoms, leading to quicker return to school, work, and/or ability to play sports.

Conditions

Post-Concussion Syndrome; Headache

Keywords

Methylprednisolone; Medrol Dose Pack; Steroid

Outcome Measures

Primary Outcomes (1)

• Change in headaches

  Defined as change in headache in response to medication

  1 Week

Secondary Outcomes (3)

• Change in total Post Concussion Symptom (0-120) scores over time

  12 weeks

• EQ-5D (Euro Qual Health State Questionnaire) score changes (1-100 in each category); higher score indicates better state of health in several domains.

  12 weeks

• Diary of other medication use and pain level

  12 weeks

Interventions

Methylprednisolone DRUG

The Methylprednisolone dose pack (Medrol Dose Pack) is pre-packaged with dosing instructions. This dose pack is tapered over 7 days and administration will be the following for all patients: Day 1 (total 24 milligrams (mg)) - 8mg before breakfast, 4mg after lunch and dinner, and 8mg at bedtime Day 2 (total 20mg) - 4mg before breakfast, after lunch and dinner, and 8mg at bedtime Day 3 (total 16mg) - 4mg before breakfast, lunch, dinner, and at bedtime Day 4 (total 12mg) - 4mg before breakfast, after lunch, and at bedtime Day 5 (total 8mg) - 4mg before breakfast and at bedtime Day 6 (total 4mg) - 4mg before breakfast Day 7 (total 0mg) - Completed

Also known as: No methylprednisolone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who meet the inclusion criteria will be consented for the study. Patients will be recruited when they follow up on their initial appointment after hospitalization

You may qualify if:

• Provision of signed and dated informed consent form (in person or via telehealth)
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged \>18 years old
• Ability to take oral medication and be willing to adhere to the study regimen as described in this protocol
• Patients presenting with all types of post-concussive headache with \>5/10 in severity on the numerical analog scale.
• Headache that occurs for \> 4 hours per day
• Headache that occurs every day
• Headache that began after concussion, patient was diagnosed at an outpatient clinic or was hospitalized
• Headache developed within 7 days post-injury and patient presenting within 30 days from initial trauma
• A diagnosis of concussion.
• If a patient is taking another pain medication, this still be included in the stud

You may not qualify if:

• Any evidence of known intracranial hemorrhage on neuroimaging
• Headache developing after 7 days post injury and patient presenting after 30 days from initial trauma
• Headache occurs \< 4 hours per day
• Headache does not occur daily
• Age \< or = 18
• Headache is \< 5 in severity on numerical analog scale
• Presence of increase in intracranial pressure or papilledema
• Any contraindication to corticosteroids
• Allergy or sensitivity to corticosteroids
• Active Tuberculosis
• Active pregnancy
• Currently on corticosteroids for another reason
• Participants with fungal infection

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Northwell Health - North Shore University Hospital

Manhasset, New York, 11030, United States

RECRUITING

Related Publications (18)

• Bulamu NB, Kaambwa B, Ratcliffe J. A systematic review of instruments for measuring outcomes in economic evaluation within aged care. Health Qual Life Outcomes. 2015 Nov 9;13:179. doi: 10.1186/s12955-015-0372-8.

  PMID: 26553129 BACKGROUND

• Bramley H, Hong J, Zacko C, Royer C, Silvis M. Mild Traumatic Brain Injury and Post-concussion Syndrome: Treatment and Related Sequela for Persistent Symptomatic Disease. Sports Med Arthrosc Rev. 2016 Sep;24(3):123-9. doi: 10.1097/JSA.0000000000000111.

  PMID: 27482778 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.

  PMID: 23034499 BACKGROUND

• Cushman DM, Borowski L, Hansen C, Hendrick J, Bushman T, Teramoto M. Gabapentin and Tricyclics in the Treatment of Post-Concussive Headache, a Retrospective Cohort Study. Headache. 2019 Mar;59(3):371-382. doi: 10.1111/head.13451. Epub 2018 Nov 19.

  PMID: 30451286 BACKGROUND

• Ducic I, Sinkin JC, Crutchfield KE. Interdisciplinary treatment of post-concussion and post-traumatic headaches. Microsurgery. 2015 Nov;35(8):603-7. doi: 10.1002/micr.22503. Epub 2015 Sep 26.

  PMID: 26409037 BACKGROUND

• EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.

  PMID: 10109801 BACKGROUND

• Halstead ME. Pharmacologic Therapies for Pediatric Concussions. Sports Health. 2016 Jan-Feb;8(1):50-2. doi: 10.1177/1941738115622158.

  PMID: 26660460 BACKGROUND

• Hoshide R, Cheung V, Marshall L, Kasper E, Chen CC. Do corticosteroids play a role in the management of traumatic brain injury? Surg Neurol Int. 2016 Sep 13;7:84. doi: 10.4103/2152-7806.190439. eCollection 2016.

  PMID: 27656315 BACKGROUND

• Kacperski J. Pharmacotherapy for Persistent Posttraumatic Headaches in Children and Adolescents: A Brief Review of the Literature. Paediatr Drugs. 2018 Oct;20(5):385-393. doi: 10.1007/s40272-018-0299-8.

  PMID: 29876872 BACKGROUND

• King NS, Crawford S, Wenden FJ, Moss NE, Wade DT. The Rivermead Post Concussion Symptoms Questionnaire: a measure of symptoms commonly experienced after head injury and its reliability. J Neurol. 1995 Sep;242(9):587-92. doi: 10.1007/BF00868811.

  PMID: 8551320 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.

  PMID: 23560811 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.

  PMID: 31638888 BACKGROUND

• Marshall S, Bayley M, McCullagh S, Velikonja D, Berrigan L, Ouchterlony D, Weegar K; mTBI Expert Consensus Group. Updated clinical practice guidelines for concussion/mild traumatic brain injury and persistent symptoms. Brain Inj. 2015;29(6):688-700. doi: 10.3109/02699052.2015.1004755. Epub 2015 Apr 14.

  PMID: 25871303 BACKGROUND

• Potter S, Leigh E, Wade D, Fleminger S. The Rivermead Post Concussion Symptoms Questionnaire: a confirmatory factor analysis. J Neurol. 2006 Dec;253(12):1603-14. doi: 10.1007/s00415-006-0275-z. Epub 2006 Oct 24.

  PMID: 17063314 BACKGROUND

• Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.

  PMID: 11491192 BACKGROUND

• Seifert T. Post-Traumatic Headache Therapy in the Athlete. Curr Pain Headache Rep. 2016 Jun;20(6):41. doi: 10.1007/s11916-016-0568-6.

  PMID: 27184059 BACKGROUND

• Solomon S. Post-traumatic headache: commentary: an overview. Headache. 2009 Jul;49(7):1112-5. doi: 10.1111/j.1526-4610.2009.01462.x.

  PMID: 19583600 BACKGROUND

• Bland JM, Altman DG. Applying the right statistics: analyses of measurement studies. Ultrasound Obstet Gynecol. 2003 Jul;22(1):85-93. doi: 10.1002/uog.122.

  PMID: 12858311 BACKGROUND

Related Links

• Medrol Dose Pack Product information

MeSH Terms

Conditions

Post-Concussion Syndrome; Headache

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Brain Concussion; Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jamie S Ullman, MD

  Hofstra Northwell School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamie Ullman, MD

CONTACT

(516) 562 4300; Jullman1@northwell.edu

Betsy Moclair, RN, CCRC

CONTACT

(516) 253-7753; bmoclair@northwell.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: April 1, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)