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

NCT05065528 | Withdrawn

• 1 other identifier: EGME#01-2021
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion, Mild; Traumatic Brain Injury, Mild

Outcome Measures

Primary Outcomes (1)

• 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

  48, 72 hours

Secondary Outcomes (2)

• adverse effect related to medication administration

  48, 72 hours

• return to baseline

  48, 72 hours

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Drug: Placebo

Intervention

EXPERIMENTAL

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

Dietary Supplement: Magnesium

Interventions

Magnesium DIETARY_SUPPLEMENT

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

Placebo DRUG

Will receive symptomatic care (ondansetron 4mg and acetaminophen 500 mg each twice daily) along with placebo pill

Control

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corewell Health South: lead

Study Sites (1)

Spectrum Health Lakeland

Saint Joseph, Michigan, 49085, United States

Location

MeSH Terms

Conditions

Brain Concussion

Interventions

Magnesium

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• Chris Trigger, DO

  Corewell Health South

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 4, 2021
• Study Start: August 30, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)