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

Part of paid clinical trials in Manhasset, New York.

Sponsor
Northwell Health
Study ID
NCT04685772
Status
Recruiting
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Conditions

  • Headache
  • Post-Concussion Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Apr 1, 2021
Status verified
Nov 2024
Primary completion
Dec 1, 2025
Completion
Dec 1, 2026

Study Design

Enrollment
25 participants (estimated)

Primary Outcome Measure

Change in headaches [ Time Frame: 1 Week ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwell Health - North Shore University HospitalManhassetNew York11030
Jamie Ullman, MD
[email protected]
516-562-4300
Betsy Moclair, RN, CCRC
[email protected]
(516) 253-7753
Dana Klavansky, MD (SUB_INVESTIGATOR)
Robert Duarte, MD (SUB_INVESTIGATOR)
Rosanna Sabini, MD (SUB_INVESTIGATOR)
Luca Giliberto, MD (SUB_INVESTIGATOR)

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By research site
Northwell Health - North Shore University Hospital· Manhasset, NY

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