Recruiting

NCT Number: NCT06260072

Magnesium and Riboflavin Treatment for Post-Concussion Headache

This clinical trial will try to determine if the supplements magnesium and riboflavin will reduce the pain and duration of headaches in persons diagnosed with a concussion. The participant will be randomized to either active magnesium and riboflavin capsules or placebo (inert) capsules. The capsules will be taken once a day for 14 days. The participant will also complete a short diary form for the 14 days and will have 3 follow up visits either by telephone or in person.

Recruiting

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Key information

Conditions

Concussion, Intermediate Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Headache Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Virginia Student Health and Wellness Center

Charlottesville, Virginia, 22903, United States

Location status: Recruiting

Location contact

Karen Ahern, BSN MBA

CONTACT

[email protected]

434-924-1549

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Seen at University of Virginia Student Health and Wellness Center or Emergency Department for Initial Visit for Concussion;
Less than 3 days have elapsed since their injury;
Able to swallow capsules

Exclusion criteria

Concussion complicated by cranial bleed, skull fracture, additional severe injury;
Kidney disfunction or failure;
Significant gastro-intestinal dysfunction;
Varsity Athlete;
Two or more previous concussions;
Women who are pregnant or breast feeding;
Taking tetracycline, fluoroquinolone, iron digoxin, chlorpromazine or penicillamine

Treatment and study plan

magnesium and riboflavin supplement

Drug

Five capsules considered one dose of the intervention (one 400 mg magnesium capsule and four 100 mg riboflavin capsules)

Primary outcomes

Headache Intensity and Duration

Time frame: 14 days

t-test of mean differences between the groups

Study contacts

Contact information is provided by the study sponsor or research team.

Karen Ahern, BSN MBA

CONTACT

[email protected]

4340924-1549

Stephanie Hartman, MD

CONTACT

[email protected]

434-924-5362

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2025
Study completion: 2025
First posted: Feb 15, 2024
Registry last updated: Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting