Concussion, MildNCT05065528
Mag Con: Efficacy of Oral Mag. in Acute Concussion in Adolescents
A study testing Magnesium in people with Concussion, Mild and Traumatic Brain Injury, Mild, run by Corewell Health South at 1 site in United States.
Trial summary
This randomized trial will compare the clinical efficacy of adding oral magnesium oxide to acetaminophen and ondansetron in the treatment of adolescents presenting within 48 hours of a mild traumatic brain injury using the Post-Concussion Symptom Severity Score Index. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Concussion, Mild, Traumatic Brain Injury, Mild
- What is being tested?
- Magnesium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 12 to 18 years;
- presenting chief complaint of headache, head injury, or concussion within the first 48 hours of injury;
- GCS > 13 on arrival
Who cannot join
- age < 12 years or > 18 years;
- inability to provide informed consent;
- vomiting > 2 episodes following injury;
- physical or mental disability hindering adequate response to assessment of symptoms;
- hemodynamic instability/medical condition requiring further acute life-saving medical intervention;
- known brain mass, intracranial hemorrhage, skull fracture;
- known contraindications/allergy to magnesium, ondansetron, or acetaminophen
- pregnant patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Spectrum Health Lakeland
Saint Joseph, Michigan, 49085
About this study
Official title: A Randomized Trial Evaluating the Efficacy of Oral Magnesium in Symptomatic Reduction of Acute Concussion in Adolescents
This randomized trial will compare the clinical efficacy of adding oral magnesium oxide to acetaminophen and ondansetron in the treatment of adolescents presenting within 48 hours of a mild traumatic brain injury using the Post-Concussion Symptom Severity Score Index.
Read the detailed description
This randomized trial will compare the clinical efficacy of oral magnesium oxide, acetaminophen and ondansetron, to that of PO acetaminophen and ondansetron in the treatment of adolescents presenting within 48 hours of a mild traumatic brain injury. Our primary endpoint will be to evaluate if magnesium has an impact on patient's Post-Concussion Symptom Severity Score Index. This will be evaluated both at the initial presentation in-person and then at 24, 48, and 72 hours via phone
- Conditions
- Concussion, Mild, Traumatic Brain Injury, Mild
- Being tested
- Magnesium, Placebo
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnesiumDietary supplement
Will receive symptomatic care (ondansetron 4mg and acetaminophen 500 mg each twice daily) along with 400 mg supplemental magnesium twice daily for 3 days
PlaceboDrug
Will receive symptomatic care (ondansetron 4mg and acetaminophen 500 mg each twice daily) along with placebo pill
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | placebo pill twice daily for 3 days ondansetron 4mg twice daily for 3 days acetaminophen 500mg twice daily for 3 days Receives: Drug: Placebo |
| Intervention | Experimental | Magnesium 500mg twice daily for 3 days ondansetron 4mg twice daily for 3 days acetaminophen 500mg twice daily for 3 days Receives: Dietary Supplement: Magnesium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Concussion Symptom Severity Score
The Post-Concussion Symptom Severity Score is a validated score measuring concussion symptoms and intensity. It measures 22 symptoms on a scale from 0 to 6. The score therefore ranges from 0 (no symptoms) through 132 (maximal symptoms). These will be evaluated at baseline as well as 48 and 72 hours from treatment. Means for each group will be calculated and compared
Measured: 48, 72 hours
Secondary outcomes (2)
adverse effect related to medication administration
proportion of patients in each group who have developed of adverse effects related to medication administration
Measured: 48, 72 hours
return to baseline
proportion of patients in each group who have experienced symptom resolution
Measured: 48, 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start30 Aug 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Why it stopped: Did not recruit any participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health South
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chris Trigger, DO, Principal investigator, Corewell Health South
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065528
- Sponsor's protocol ID
- EGME#01-2021
- Status last verified
- Nov 2024
- First submitted
- 23 Sep 2021
- Last updated
- 29 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Evaluating the Efficacy of Oral Magnesium in Symptomatic Reduction of Acute Concussion in Adolescents
- ClinicalTrials.gov ID
- NCT05065528
- Acronym / sponsor ID
- EGME#01-2021
- Conditions
- Concussion, Mild, Traumatic Brain Injury, Mild
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not recruit any participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Corewell Health SouthUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 4 Oct 2021 (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 randomized trial will compare the clinical efficacy of adding oral magnesium oxide to acetaminophen and ondansetron in the treatment of adolescents presenting within 48 hours of a mild traumatic brain injury using the Post-Concussion Symptom Severity Score Index.
Detailed description
This randomized trial will compare the clinical efficacy of oral magnesium oxide, acetaminophen and ondansetron, to that of PO acetaminophen and ondansetron in the treatment of adolescents presenting within 48 hours of a mild traumatic brain injury. Our primary endpoint will be to evaluate if magnesium has an impact on patient's Post-Concussion Symptom Severity Score Index. This will be evaluated both at the initial presentation in-person and then at 24, 48, and 72 hours via phone
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Placeboplacebo pill twice daily for 3 days ondansetron 4mg twice daily for 3 days acetaminophen 500mg twice daily for 3 days |
| Intervention | Experimental | Dietary Supplement: MagnesiumMagnesium 500mg twice daily for 3 days ondansetron 4mg twice daily for 3 days acetaminophen 500mg twice daily for 3 days |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- age 12 to 18 years;
- presenting chief complaint of headache, head injury, or concussion within the first 48 hours of injury;
- GCS > 13 on arrival
Key exclusion criteria (8 listed)
- age < 12 years or > 18 years;
- inability to provide informed consent;
- vomiting > 2 episodes following injury;
- physical or mental disability hindering adequate response to assessment of symptoms;
- hemodynamic instability/medical condition requiring further acute life-saving medical intervention;
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 |
|---|---|---|
| MagnesiumWill receive symptomatic care (ondansetron 4mg and acetaminophen 500 mg each twice daily) along with 400 mg supplemental magnesium twice daily for 3 days | Dietary supplement | Intervention |
| PlaceboWill receive symptomatic care (ondansetron 4mg and acetaminophen 500 mg each twice daily) along with placebo pill | Drug | Control |
Primary outcome
Post-Concussion Symptom Severity Score
Time frame: 48, 72 hours
The Post-Concussion Symptom Severity Score is a validated score measuring concussion symptoms and intensity. It measures 22 symptoms on a scale from 0 to 6. The score therefore ranges from 0 (no symptoms) through 132 (maximal symptoms). These will be evaluated at baseline as well as 48 and 72 hours from treatment. Means for each group will be calculated and compared
2 secondary outcomes
adverse effect related to medication administration
Time frame: 48, 72 hours
return to baseline
Time frame: 48, 72 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- 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. This study is not recruiting at the moment.
Chris Trigger, DO principal investigator
Corewell Health South
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium in people with Concussion, Mild and Traumatic Brain Injury, Mild, run by Corewell Health South 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 8 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: withdrawn, as of the sponsor's last update on 29 Nov 2024. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Concussion Symptom Severity Score (time frame: 48, 72 hours). 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 29 Nov 2024.