Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 to 85

Using magnesium sulfate to treat acute headaches in the emergency department

Official title: Intravenous Magnesium Sulfate Vs Placebo to Treat Non-traumatic Acute Headaches in the Emergency Department

Run by University of Monastir · NCT05325580 · Data updated 2026-11-12

This study tests if giving magnesium sulfate through an IV can help people with sudden headaches in the emergency room feel better compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 85 Years
SexAll
Enrollment424 (estimated)
SponsorUniversity of Monastir
Academic / other
Locations1 site (Monastir)
StatusRecruiting
StartedDecember 1, 2021
Main results expectedDecember 1, 2025
Study endsDecember 30, 2026
Registry record updatedFebruary 28, 2024
Trial IDNCT05325580 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults over 18 years old experiencing acute non-traumatic headaches who are being treated in the emergency department.

Probably not a fit

Patients with chronic headaches, traumatic headaches, or those with certain medical conditions such as renal disorders or neuromuscular disorders may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of intravenous magnesium sulfate compared to a placebo in treating non-traumatic acute headaches in patients visiting the emergency department. The study involves administering magnesium sulfate and aspirin intravenously to eligible participants while monitoring their headache relief. It aims to determine if magnesium sulfate can provide significant pain relief for acute headaches, potentially offering a new treatment option in emergency settings.

Why it matters

Potential benefit: If successful, this treatment could provide rapid and effective relief for patients suffering from acute headaches in emergency situations.

How similar studies have gone: While the use of magnesium sulfate for various conditions has been explored, this specific application for acute headaches in the emergency department is relatively novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* informed consent
* age \>18 years
* Acute non-traumatic acute headaches
* patients treated in ED
* Magnesium sulfate and aspirin administered intravenously (IV)

Exclusion Criteria:

* 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
* Traumatic Headache
* Chronic headache ( headache occurring at least 15 days per month for at least 3 months)
* Hemodynamic instability

Where it's running

  • University of Monasrtir
    Monastir, Tunisia
    Recruiting

Study contacts

  • Principal investigator: Semir Nouira, Professor — University of Monastir
  • Study coordinator: Semir Nouira, Professor
  • Email: semir.nouira@rns.tn
  • Phone: 7310600

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.