Magnesium and Riboflavin Treatment for Post-Concussion Headache
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:
• 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
Locations
United States
Virginia
University of Virginia Student Health and Wellness Center
RECRUITING
Charlottesville
Contact Information
Primary
Stephanie Hartman, MD
slm8nh@virginia.edu
434-924-5362
Backup
Karen Ahern, BSN MBA
kaa7p@virginia.edu
4340924-1549
Time Frame
Start Date: 2020-02-10
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 108
Treatments
Active_comparator: Active study product
400 mg of Magnesium Oxide and 400 mg Riboflavin in capsule formation
Placebo_comparator: Placebo study product
Inert placebo in capsule formation
Related Therapeutic Areas
Sponsors
Leads: University of Virginia