Assessment of the Efficacy of Medrol Dose Pack for Acute Post-Concussive Headaches
NCT04685772 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 25
Last updated 2024-11-12
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
Interventions
- DRUG
-
Methylprednisolone
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
Sponsors & Collaborators
-
Northwell Health
lead OTHER
Principal Investigators
-
Jamie S Ullman, MD · Hofstra Northwell School of Medicine
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-01
- Primary Completion
- 2025-12-01
- Completion
- 2026-12-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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