Recruiting

Magnesium and Riboflavin Treatment for Post-Concussion Headache

What is being tested

magnesium and riboflavin supplement

Drug

Who is being recruted

Brain Injuries, Traumatic+13

+ Brain Concussion

+ Brain Diseases

From 18 to 40 Years

+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 2

Interventional

Study Start: February 2020

See protocol details

Summary

Principal SponsorUniversity of Virginia

Study ContactStephanie Hartman, MDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 10, 2020

Actual date on which the first participant was enrolled.

The study aims to find out if taking magnesium and riboflavin supplements can help reduce the pain and length of headaches after someone experiences a concussion. This study is important as it seeks to provide a simple and potentially effective way to manage headaches, which are a common problem for those who have suffered a concussion. By exploring this treatment, the study hopes to offer relief to individuals dealing with these challenging symptoms. Participants in the study will be randomly assigned to take either the magnesium and riboflavin supplements or a placebo, which is a non-active substance, for 14 days. They will take one capsule each day. Throughout this period, participants will keep a short daily diary to record their headache experiences. Additionally, they will have three follow-up appointments, which can be either over the phone or in person, to monitor their progress. This setup helps researchers gather data on how effective the supplements are in reducing headache symptoms post-concussion.

Official TitleMagnesium and Riboflavin Treatment for Post-Concussion Headache

NCT06260072

Principal SponsorUniversity of Virginia

Study ContactStephanie Hartman, MDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

108 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain Injuries, TraumaticBrain ConcussionBrain DiseasesBrain InjuriesCentral Nervous System DiseasesCraniocerebral TraumaHeadacheNervous System DiseasesNeurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and InjuriesWounds, NonpenetratingHead Injuries, ClosedTrauma, Nervous System

Criteria

3 inclusion criteria required to participate

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

7 exclusion criteria prevent from participating

Concussion complicated by cranial bleed, skull fracture, additional severe injury;

Kidney disfunction or failure;

Significant gastro-intestinal dysfunction;

Varsity Athlete;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

400 mg of Magnesium Oxide and 400 mg Riboflavin in capsule formation

Group II

Placebo

Inert placebo in capsule formation

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

University of Virginia Student Health and Wellness Center

Charlottesville, United StatesOpen University of Virginia Student Health and Wellness Center in Google Maps

Recruiting

One Study Center