Magnesium and Riboflavin Treatment for Post-Concussion Headache

NCT06260072 | Recruiting Phase 2 FDA Drug

• 1 other identifier: IRB-HSR 21920
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Concussion; Headache

Outcome Measures

Primary Outcomes (1)

• Headache Intensity and Duration

  t-test of mean differences between the groups

  14 days

Study Arms (2)

Active study product

ACTIVE COMPARATOR

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

Drug: magnesium and riboflavin supplement

Placebo study product

PLACEBO COMPARATOR

Inert placebo in capsule formation

Drug: magnesium and riboflavin supplement

Interventions

magnesium and riboflavin supplement DRUG

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

Active study product; Placebo study product

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Student Health and Wellness Center

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion; Headache

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; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Stephanie Hartman, MD

  UVA Student Health and Wellness

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Hartman, MD

CONTACT

434-924-5362; slm8nh@virginia.edu

Karen Ahern, BSN MBA

CONTACT

4340924-1549; kaa7p@virginia.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Primary Care UVA Student Health & Wellness

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 15, 2024
• Study Start: February 10, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)