Head PainPhase 3NCT05325580
Intravenous Magnesium Sulfate Vs Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department
A Phase 3 study testing Magnesium sulfate in people with Head Pain, run by University of Monastir at 1 site in Tunisia.
Trial summary
Intravenous Magnesium Sulfate Vs Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Head Pain
- What is being tested?
- Magnesium sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 424 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Dec 2021to 30 Dec 2026
- Phase
- Phase 3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent
- age >18 years
- Acute non-traumatic acute headaches
- patients treated in ED
- Magnesium sulfate and aspirin administered intravenously (IV)
Who cannot join
- Current regular use of analgesics, anticonvulsants or antidepressants
- Renal disorder with a low glomerular filtration rate (<60 ml/min)
- Neuromuscular disorder
- Pregnant woman
- Contrindication
- Allergy to NSAID
Show all 9Show fewer
- Traumatic Headache
- Chronic headache ( headache occurring at least 15 days per month for at least 3 months)
- Hemodynamic instability
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia1 site, 1 recruiting
- Recruiting
University of Monasrtir
Monastir, 5060
Nouira Semir, professor, 73106046, semir.nouira@rns.tn
About this study
Official title: Intravenous Magnesium Sulfate Vs Placebo to Treat Non-traumatic Acute Headaches in the Emergency Department
Intravenous Magnesium Sulfate Vs Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department
Read the detailed description
Rate of Intravenous Magnesium Sulfate Vs Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department
- Conditions
- Head Pain
- Being tested
- Magnesium sulfate
- Keywords
- intavenous, magnesium sulfate, nontraumatic, acute headaches, placebo
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfateDrug
Also called placebo
magnesium group 1g paracetamol + 20 min infusion of 2 g magnesium in 150 ml of saline serum and Placebo Group
1g paracetamol + 20 min infusion of 150 ml of saline serum
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | 1g paracetamol + 20 min infusion of 150ml of saline serum Receives: Drug: Magnesium sulfate |
| magnesium group | Experimental | 1g paracetamol + 20 min infusion of 2g magnesium in 150 ml of serum saline Receives: Drug: Magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intravenous Magnesium Sulfate to Treat Non -Traumatic Acute Headaches in the Emergency Department
Patients with Non -Traumatic Acute Headaches in the Emergency Department recived 1g paracetamol + 20 min infusion of 2g magnesium
Measured: 1day
Secondary outcomes (1)
Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department
Patients with Non -Traumatic Acute Headaches in the Emergency Department received 1g paracetamol + 20 min infusion of saline serum
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start1 Dec 2021
- Primary completion1 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head PainStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 424 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Semir Nouira, Professor, Principal investigator, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325580
- Sponsor's protocol ID
- Emergency Monastir
- Status last verified
- Feb 2023
- First submitted
- 16 Mar 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Magnesium Sulfate Vs Placebo to Treat Non-traumatic Acute Headaches in the Emergency Department
- ClinicalTrials.gov ID
- NCT05325580
- Acronym / sponsor ID
- Emergency Monastir
- Conditions
- Head Pain
- Keywords
- intavenous, magnesium sulfate, nontraumatic, acute headaches, placebo
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 424 participants (estimated)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 13 Apr 2022 (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.
Intravenous Magnesium Sulfate Vs Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department
Detailed description
Rate of Intravenous Magnesium Sulfate Vs Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Drug: Magnesium sulfate1g paracetamol + 20 min infusion of 150ml of saline serum |
| magnesium group | Experimental | Drug: Magnesium sulfate1g paracetamol + 20 min infusion of 2g magnesium in 150 ml of serum saline |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- informed consent
- age >18 years
- Acute non-traumatic acute headaches
- patients treated in ED
- Magnesium sulfate and aspirin administered intravenously (IV)
Key exclusion criteria (9 listed)
- Current regular use of analgesics, anticonvulsants or antidepressants
- Renal disorder with a low glomerular filtration rate (<60 ml/min)
- Neuromuscular disorder
- Pregnant woman
- Contrindication
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 sulfateAlso: placebomagnesium group 1g paracetamol + 20 min infusion of 2 g magnesium in 150 ml of saline serum and Placebo Group 1g paracetamol + 20 min infusion of 150 ml of saline serum | Drug | Placebo Group, magnesium group |
Primary outcome
Intravenous Magnesium Sulfate to Treat Non -Traumatic Acute Headaches in the Emergency Department
Time frame: 1day
Patients with Non -Traumatic Acute Headaches in the Emergency Department recived 1g paracetamol + 20 min infusion of 2g magnesium
1 secondary outcome
Placebo to Treat Non -Traumatic Acute Headaches in the Emergency Department
Time frame: 1 day
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 28 Feb 2024.
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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.
Semir Nouira, Professor principal investigator
University of Monastir
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Magnesium sulfate in people with Head Pain, run by University of Monastir at 1 site in Tunisia.
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 5 inclusion and 9 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 28 Feb 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 Tunisia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Semir Nouira, Professor (7310600 ext. 216, semir.nouira@rns.tn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intravenous Magnesium Sulfate to Treat Non -Traumatic Acute Headaches in the Emergency Department (time frame: 1day). 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 28 Feb 2024.