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Mag Con: Efficacy of Oral Mag. in Acute Concussion in Adolescents

Primary Purpose

Concussion, Mild, Traumatic Brain Injury, Mild

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnesium
Placebo
Sponsored by
Spectrum Health - Lakeland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Concussion, Mild

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 12 to 18 years;
  • presenting chief complaint of headache, head injury, or concussion within the first 48 hours of injury;
  • GCS > 13 on arrival

Exclusion Criteria:

  • age < 12 years or > 18 years;
  • inability to provide informed consent;
  • vomiting > 2 episodes following injury;
  • physical or mental disability hindering adequate response to assessment of symptoms;
  • hemodynamic instability/medical condition requiring further acute life-saving medical intervention;
  • known brain mass, intracranial hemorrhage, skull fracture;
  • known contraindications/allergy to magnesium, ondansetron, or acetaminophen
  • pregnant patients

Sites / Locations

  • Spectrum Health Lakeland

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

placebo pill twice daily for 3 days ondansetron 4mg twice daily for 3 days acetaminophen 500mg twice daily for 3 days

Magnesium 500mg twice daily for 3 days ondansetron 4mg twice daily for 3 days acetaminophen 500mg twice daily for 3 days

Outcomes

Primary Outcome Measures

Post-Concussion Symptom Severity Score
The Post-Concussion Symptom Severity Score is a validated score measuring concussion symptoms and intensity. It measures 22 symptoms on a scale from 0 to 6. The score therefore ranges from 0 (no symptoms) through 132 (maximal symptoms). These will be evaluated at baseline as well as 48 and 72 hours from treatment. Means for each group will be calculated and compared

Secondary Outcome Measures

adverse effect related to medication administration
proportion of patients in each group who have developed of adverse effects related to medication administration
return to baseline
proportion of patients in each group who have experienced symptom resolution

Full Information

First Posted
September 23, 2021
Last Updated
August 11, 2022
Sponsor
Spectrum Health - Lakeland
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1. Study Identification

Unique Protocol Identification Number
NCT05065528
Brief Title
Mag Con: Efficacy of Oral Mag. in Acute Concussion in Adolescents
Official Title
A Randomized Trial Evaluating the Efficacy of Oral Magnesium in Symptomatic Reduction of Acute Concussion in Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Did not recruit any participants
Study Start Date
August 30, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectrum Health - Lakeland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
This randomized trial will compare the clinical efficacy of adding oral magnesium oxide to acetaminophen and ondansetron in the treatment of adolescents presenting within 48 hours of a mild traumatic brain injury using the Post-Concussion Symptom Severity Score Index.
Detailed Description
This randomized trial will compare the clinical efficacy of oral magnesium oxide, acetaminophen and ondansetron, to that of PO acetaminophen and ondansetron in the treatment of adolescents presenting within 48 hours of a mild traumatic brain injury. Our primary endpoint will be to evaluate if magnesium has an impact on patient's Post-Concussion Symptom Severity Score Index. This will be evaluated both at the initial presentation in-person and then at 24, 48, and 72 hours via phone

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Mild, Traumatic Brain Injury, Mild

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
placebo pill twice daily for 3 days ondansetron 4mg twice daily for 3 days acetaminophen 500mg twice daily for 3 days
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Magnesium 500mg twice daily for 3 days ondansetron 4mg twice daily for 3 days acetaminophen 500mg twice daily for 3 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Magnesium
Intervention Description
Will receive symptomatic care (ondansetron 4mg and acetaminophen 500 mg each twice daily) along with 400 mg supplemental magnesium twice daily for 3 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Will receive symptomatic care (ondansetron 4mg and acetaminophen 500 mg each twice daily) along with placebo pill
Primary Outcome Measure Information:
Title
Post-Concussion Symptom Severity Score
Description
The Post-Concussion Symptom Severity Score is a validated score measuring concussion symptoms and intensity. It measures 22 symptoms on a scale from 0 to 6. The score therefore ranges from 0 (no symptoms) through 132 (maximal symptoms). These will be evaluated at baseline as well as 48 and 72 hours from treatment. Means for each group will be calculated and compared
Time Frame
48, 72 hours
Secondary Outcome Measure Information:
Title
adverse effect related to medication administration
Description
proportion of patients in each group who have developed of adverse effects related to medication administration
Time Frame
48, 72 hours
Title
return to baseline
Description
proportion of patients in each group who have experienced symptom resolution
Time Frame
48, 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 12 to 18 years; presenting chief complaint of headache, head injury, or concussion within the first 48 hours of injury; GCS > 13 on arrival Exclusion Criteria: age < 12 years or > 18 years; inability to provide informed consent; vomiting > 2 episodes following injury; physical or mental disability hindering adequate response to assessment of symptoms; hemodynamic instability/medical condition requiring further acute life-saving medical intervention; known brain mass, intracranial hemorrhage, skull fracture; known contraindications/allergy to magnesium, ondansetron, or acetaminophen pregnant patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Trigger, DO
Organizational Affiliation
Spectrum Health - Lakeland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spectrum Health Lakeland
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Mag Con: Efficacy of Oral Mag. in Acute Concussion in Adolescents

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