Concussion, IntermediatePhase 2NCT06260072
Magnesium and Riboflavin Treatment for Post-Concussion Headache
A Phase 2 study testing magnesium and riboflavin supplement in people with Concussion, Intermediate, run by University of Virginia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Concussion, Intermediate
- What is being tested?
- magnesium and riboflavin supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2020to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Virginia Student Health and Wellness Center
Charlottesville, Virginia, 22903
Karen Ahern, BSN MBA, 434-924-1549, kaa7p@virginia.edu
About this study
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.
- Conditions
- Concussion, Intermediate
- Being tested
- magnesium and riboflavin supplement
- Keywords
- Concussion; Headache
- Medical subject headings
- Brain Concussion, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnesium and riboflavin supplementDrug
Five capsules considered one dose of the intervention (one 400 mg magnesium capsule and four 100 mg riboflavin capsules)
| Study group | Role | What they receive |
|---|---|---|
| Active study product | Active comparator | 400 mg of Magnesium Oxide and 400 mg Riboflavin in capsule formation Receives: Drug: magnesium and riboflavin supplement |
| Placebo study product | Placebo comparator | Inert placebo in capsule formation Receives: Drug: magnesium and riboflavin supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Intensity and Duration
t-test of mean differences between the groups
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start10 Feb 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, IntermediateStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Hartman, MD, University of Virginia
- Investigators
- Stephanie Hartman, MD, Principal investigator, UVA Student Health and Wellness
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260072
- Sponsor's protocol ID
- IRB-HSR 21920
- Status last verified
- Mar 2025
- First submitted
- 6 Feb 2024
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium and Riboflavin Treatment for Post-Concussion Headache
- ClinicalTrials.gov ID
- NCT06260072
- Acronym / sponsor ID
- IRB-HSR 21920
- Conditions
- Concussion, Intermediate
- Keywords
- Concussion; Headache
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active study product | Active comparator | Drug: magnesium and riboflavin supplement400 mg of Magnesium Oxide and 400 mg Riboflavin in capsule formation |
| Placebo study product | Placebo comparator | Drug: magnesium and riboflavin supplementInert placebo in capsule formation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnesium and riboflavin supplementFive capsules considered one dose of the intervention (one 400 mg magnesium capsule and four 100 mg riboflavin capsules) | Drug | Active study product, Placebo study product |
Primary outcome
Headache Intensity and Duration
Time frame: 14 days
t-test of mean differences between the groups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephanie Hartman, MD principal investigator
UVA Student Health and Wellness
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing magnesium and riboflavin supplement in people with Concussion, Intermediate, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Hartman, MD (434-924-5362, slm8nh@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Intensity and Duration (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.