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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Magnesium and Riboflavin Treatment for Post-Concussion Headache

Magnesium and Riboflavin Treatment for Post-Concussion Headache (NCT06260072) is a Phase 2 interventional studying Concussion, Intermediate, sponsored by University of Virginia. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Concussion, Intermediate and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 108 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Concussion, Intermediate subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

magnesium and riboflavin supplement

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University of Virginia Student Health and Wellness Center
Charlottesville, Virginia, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06260072), the sponsor (University of Virginia), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06260072 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06260072?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06260072?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06260072. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06260072. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.