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A Cohort Study Evaluating the Efficacy of PO Magnesium in the Treatment of Acute Traumatic Brain Injury in Adolescents

NCT03475693 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-11-29

No results posted yet for this study

Summary

The objective of this study is to evaluate the efficacy of magnesium in symptomatic reduction of mild traumatic brain injury in the adolescent population in the acute setting of injury.

Conditions

  • Concussion Post Syndrome

Interventions

DRUG

Magnesium Oxide

400 mg Magnesium oxide tablet given once in the ED, and prescribed to take BID for 5 days total after discharge

DRUG

Acetaminophen

500 mg tablets given once in the ED, and prescribed to take BID for 5 days total after discharge.

DRUG

Zofran ODT 4 MG Disintegrating Oral Tablet

Given once in the Emergency department

Sponsors & Collaborators

Principal Investigators

  • Christopher Trigger, MD, CAQSM · Lakeland Regional Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2019-11-30
Completion
2019-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03475693 on ClinicalTrials.gov