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Active study product for Concussion

Phase 2

Recruiting

Led By Stephanie Hartman, MD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to swallow capsules

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days

Awards & highlights

Study Summary

This trial will investigate whether magnesium and riboflavin supplements can help reduce headache pain and duration in individuals with a concussion. Participants will be randomly assigned to take either the active supplements or placebo capsules once

Who is the study for?

This trial is for individuals who have been diagnosed with a concussion and are experiencing headaches. Participants will take capsules daily for two weeks and keep a diary of their headache symptoms. They must be available for three follow-up visits or calls.Check my eligibility

What is being tested?

The study is testing whether magnesium and riboflavin supplements can help reduce the pain and frequency of post-concussion headaches compared to placebo capsules, which have no active ingredients.See study design

What are the potential side effects?

Possible side effects from magnesium may include stomach upset or diarrhea, while riboflavin could potentially cause urine discoloration; however, both are generally considered safe at recommended doses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can swallow pills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Headache Intensity and Duration

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active study productActive Control1 Intervention

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

Group II: Placebo study productPlacebo Group1 Intervention

Inert placebo in capsule formation

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor

754 Previous Clinical Trials

1,244,965 Total Patients Enrolled

Stephanie Hartman, MDPrincipal InvestigatorUVA Student Health and Wellness

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial include individuals who are above the age of 65?

"Individuals aged between 18 and 40 are eligible to participate in this trial."

Answered by AI

Which individuals are eligible to participate in this research study?

"Individuals aged between 18 and 40 with a diagnosis of concussion are eligible to participate in this trial, which has spots available for approximately 108 participants."

Answered by AI

Is this medical study currently accepting participants for enrollment?

"The search for suitable candidates is ongoing as detailed on clinicaltrials.gov. The study's original posting was on February 10th, 2020 and its latest update was made on February 6th, 2024."

Answered by AI

What is the upper limit for participant enrollment in this research investigation?

"Affirmative. Data available on clinicaltrials.gov indicates that this investigation is actively seeking candidates. The trial was originally posted on February 10th, 2020 and last revised on February 6th, 2024. There are plans to enroll a total of 108 participants at a single site."

Answered by AI

Has the investigational drug in this research study received approval from the FDA?

"The safety assessment by our team at Power rates the investigational product in this Phase 2 trial as a level 2. This grade signifies existing data on safety but not yet on efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Magnesium and Riboflavin Treatment for Post-Concussion Headache

Stephanie Hartman, MD 2020. "Magnesium and Riboflavin Treatment for Post-Concussion Headache". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06260072.

All > Concussion