An interventional study of Magnesium Sulfate 2 grams and Magnesium Sulfate 4 G in Acute Headache, Migraine and Tension-type Headache, sponsored by University of Monastir. Recruiting at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by University of Monastir · Not applicable, Interventional, and Treatment
Headache is one of the most common reasons for consultation in emergency departments and represents a significant cause of disability, particularly in patients with migraine and other primary headache disorders. Despite the availability of several analgesic treatments, including nonsteroidal anti-inflammatory drugs and paracetamol, pain relief is often incomplete, and a proportion of patients require additional rescue therapy.
Magnesium sulfate has emerged as a potential therapeutic option in acute headache due to its role in modulating neuronal excitability, vascular tone, and pain-related neurotransmitter release. However, its efficacy as a standalone treatment, the optimal intravenous dose, and its comparative effectiveness versus standard therapy remain unclear.
This randomized, double-blind, controlled trial aims to evaluate the efficacy and safety of intravenous magnesium sulfate in the treatment of acute non-traumatic headache in the emergency department. Participants will be randomly assigned to receive either low-dose magnesium sulfate (2 g IV), high-dose magnesium sulfate (4 g IV), or intravenous paracetamol (1 g IV) as an active comparator.
The primary outcome is the change in pain intensity measured using the Visual Analog Scale (VAS) at 60 minutes after treatment administration, as well as the proportion of patients achieving at least 50% pain reduction. Secondary outcomes include time course of pain relief, need for rescue medication, adverse events, patient satisfaction, and length of stay in the emergency department.
In addition, the study will assess baseline ionized magnesium levels to explore their relationship with treatment response and evaluate whether magnesium levels may predict clinical efficacy.
The results of this study may help clarify the role of intravenous magnesium sulfate in the management of acute headache and potentially improve treatment strategies in emergency settings.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 300 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →University of Monastir is the lead sponsor of 114 studies on the registry; 29 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis consistent with a primary headache disorder, including:
Exclusion Criteria:
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravenous magnesium sulfate administered as a single dose of 2 g diluted in 100 mL of 0.9% sodium chloride over 10-15 minutes.
Drug: Magnesium Sulfate 2 grams
Intravenous magnesium sulfate administered as a single dose of 4 g diluted in 100 mL of 0.9% sodium chloride over 10-15 minutes.
Drug: Magnesium Sulfate 4 G
Intravenous paracetamol 1 g diluted in 100 mL, administered over 10-15 minutes.
Drug: Paracetamol 1 g
Participants assigned to this arm will receive intravenous magnesium sulfate 2 g diluted in 100 mL of 0.9% sodium chloride administered over 10-15 minutes, along with a matching placebo for paracetamol. Infusions will be prepared in identical formats to maintain blinding. Continuous monitoring of vital signs will be performed during and after administration. Rescue medication may be administered from 30 minutes if predefined criteria are met.
Participants assigned to this arm will receive intravenous magnesium sulfate 4 g diluted in 100 mL of 0.9% sodium chloride administered over 10-15 minutes, along with a matching placebo for paracetamol.. Infusions will be prepared in identical formats to maintain blinding. Continuous monitoring of vital signs will be performed during and after administration. Rescue medication may be administered from 30 minutes if predefined criteria are met.
Participants assigned to this arm will receive intravenous paracetamol 1 g administered over 10-15 minutes, along with a matching placebo for magnesium (100 mL of 0.9% sodium chloride). Infusions will be prepared in identical formats to maintain blinding. Continuous monitoring of vital signs will be performed during and after administration. Rescue medication may be administered from 30 minutes if predefined criteria are met.
Change in Pain Intensity at 60 Minutes
Change in pain intensity measured using the Visual Analog Scale (VAS, 0-10) from baseline to 60 minutes after treatment administration
Time frame: 60 minutes
Proportion of Responders at 60 Minutes
Proportion of participants achieving a ≥50% reduction in VAS pain score from baseline at 60 minutes.
Time frame: 60 minutes
Pain Intensity Over Time
Area under the curve (AUC) of VAS pain scores measured from baseline to 120 minutes.
Time frame: 0 to 120 minutes
Time to Clinically Meaningful Pain Relief
Time from treatment administration to achievement of clinically meaningful pain relief, defined as VAS ≤3 or ≥50% reduction from baseline.
Time frame: Up to 120 minutes
Use of Rescue Medication
Proportion of participants requiring rescue analgesia after 30 minutes due to insufficient pain relief.
Time frame: 30 to 120 minutes
Adverse Events
Incidence and type of treatment-emergent adverse events during the observation period.
Time frame: 0 to 120 minutes
Patient Satisfaction
Patient-reported satisfaction with treatment using a standardized scale.
Time frame: 120 minutes
Association Between Ionized Magnesium and Treatment Response
Relationship between baseline ionized magnesium levels and analgesic response at 60 minutes.
Time frame: Baseline to 60 minutes
Started Jun 2026 (actual). Primary completion is estimated for Dec 2029, 42 months after the start.
Of 309 non-industry interventional studies with no phase under Migraine Disorders, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 42 months is above that.
Counting every sponsor, half of 358 studies reached it within 15 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Magnesium Sulfate · Acetaminophen