Acute HeadacheMAGHEADNCT07779486
High- vs Standard-Dose Intravenous Magnesium for Acute Headache
A study testing Magnesium Sulfate 2 grams, Magnesium Sulfate 4 G and Paracetamol 1 g in people with Acute Headache and Migraine, run by University of Monastir at 1 site in Tunisia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Headache, Migraine, Tension-type Headache
- What is being tested?
- Magnesium Sulfate 2 grams, Magnesium Sulfate 4 G and Paracetamol 1 g
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jun 2026to 31 Dec 2030
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Presentation to the emergency department with acute non-traumatic headache of less than 72 hours duration
- Diagnosis consistent with a primary headache disorder, including:
- Migraine
- Tension-type headache
- Cluster headache (according to ICHD-3 criteria)
- Moderate to severe pain intensity (VAS ≥5/10)
- Ability to understand the study procedures and provide informed consent
Who cannot join
- Suspected or confirmed secondary headache (e.g., intracranial hemorrhage, infection, mass lesion)
- Recent head trauma
- Known hypersensitivity or contraindication to magnesium sulfate or paracetamol
- Use of analgesic medication within the previous 6 hours
- Pregnancy or breastfeeding
- Severe renal insufficiency or conditions contraindicating magnesium administration
- Hemodynamic instability or clinically significant cardiac conduction disorders Prior participation in this study
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 Hospital Fattouma Bourguiba Monastir
Monastir, 5000
Semir Nouira, Professor, 73106046 ext. 00216, semir.nouira@rns.tn
About this study
Official title: Intravenous Magnesium Sulfate Versus Paracetamol for the Treatment of Acute Non-Traumatic Headache in the Emergency Department: A Randomized Double-Blind Controlled Trial
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.
Read more
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.
- Conditions
- Acute Headache, Migraine, Tension-type Headache, Cluster Headache
- Being tested
- Magnesium Sulfate 2 grams, Magnesium Sulfate 4 G, Paracetamol 1 g
- Keywords
- Acute headache, Migraine, Emergency department, Intravenous magnesium Magnesium sulfate, Paracetamol, Acute pain, Analgesia
- Medical subject headings
- Migraine Disorders, Tension-Type Headache, Cluster Headache, Emergencies, Acute Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Sulfate 2 gramsDrug
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.
Magnesium Sulfate 4 GDrug
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.
Paracetamol 1 gDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Sulfate 2 g IV | Active comparator | Intravenous magnesium sulfate administered as a single dose of 2 g diluted in 100 mL of 0.9% sodium chloride over 10-15 minutes. Receives: Drug: Magnesium Sulfate 2 grams |
| Magnesium Sulfate 4 g IV | Active comparator | Intravenous magnesium sulfate administered as a single dose of 4 g diluted in 100 mL of 0.9% sodium chloride over 10-15 minutes. Receives: Drug: Magnesium Sulfate 4 G |
| Paracetamol 1 g IV | Active comparator | Intravenous paracetamol 1 g diluted in 100 mL, administered over 10-15 minutes. Receives: Drug: Paracetamol 1 g |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 60 minutes
Proportion of Responders at 60 Minutes
Proportion of participants achieving a ≥50% reduction in VAS pain score from baseline at 60 minutes.
Measured: 60 minutes
Secondary outcomes (4)
Pain Intensity Over Time
Area under the curve (AUC) of VAS pain scores measured from baseline to 120 minutes.
Measured: 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.
Measured: Up to 120 minutes
Use of Rescue Medication
Proportion of participants requiring rescue analgesia after 30 minutes due to insufficient pain relief.
Measured: 30 to 120 minutes
Adverse Events
Incidence and type of treatment-emergent adverse events during the observation period.
Measured: 0 to 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Jun 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute HeadacheStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779486
- Sponsor's protocol ID
- MAGHEAD_study
- Acronym
- MAGHEAD
- Status last verified
- Aug 2026
- First submitted
- 19 May 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Magnesium Sulfate Versus Paracetamol for the Treatment of Acute Non-Traumatic Headache in the Emergency Department: A Randomized Double-Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT07779486
- Acronym / sponsor ID
- MAGHEAD / MAGHEAD_study
- Conditions
- Acute Headache, Migraine, Tension-type Headache, Cluster Headache
- Keywords
- Acute headache, Migraine, Emergency department, Intravenous magnesium Magnesium sulfate, Paracetamol, Acute pain, Analgesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 21 Aug 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Magnesium Sulfate 2 g IV | Active comparator | Drug: Magnesium Sulfate 2 gramsIntravenous magnesium sulfate administered as a single dose of 2 g diluted in 100 mL of 0.9% sodium chloride over 10-15 minutes. |
| Magnesium Sulfate 4 g IV | Active comparator | Drug: Magnesium Sulfate 4 GIntravenous magnesium sulfate administered as a single dose of 4 g diluted in 100 mL of 0.9% sodium chloride over 10-15 minutes. |
| Paracetamol 1 g IV | Active comparator | Drug: Paracetamol 1 gIntravenous paracetamol 1 g diluted in 100 mL, administered over 10-15 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years
- Presentation to the emergency department with acute non-traumatic headache of less than 72 hours duration
- Diagnosis consistent with a primary headache disorder, including:
- Moderate to severe pain intensity (VAS ≥5/10)
- Ability to understand the study procedures and provide informed consent
Key exclusion criteria (7 listed)
- Suspected or confirmed secondary headache (e.g., intracranial hemorrhage, infection, mass lesion)
- Recent head trauma
- Known hypersensitivity or contraindication to magnesium sulfate or paracetamol
- Use of analgesic medication within the previous 6 hours
- Pregnancy or breastfeeding
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 Sulfate 2 gramsParticipants 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. | Drug | Magnesium Sulfate 2 g IV |
| Magnesium Sulfate 4 GParticipants 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. | Drug | Magnesium Sulfate 4 g IV |
| Paracetamol 1 gParticipants 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. | Drug | Paracetamol 1 g IV |
Primary outcome
Change in Pain Intensity at 60 Minutes
Time frame: 60 minutes
Change in pain intensity measured using the Visual Analog Scale (VAS, 0-10) from baseline to 60 minutes after treatment administration
Proportion of Responders at 60 Minutes
Time frame: 60 minutes
Proportion of participants achieving a ≥50% reduction in VAS pain score from baseline at 60 minutes.
4 secondary outcomes
Pain Intensity Over Time
Time frame: 0 to 120 minutes
Time to Clinically Meaningful Pain Relief
Time frame: Up to 120 minutes
Use of Rescue Medication
Time frame: 30 to 120 minutes
Adverse Events
Time frame: 0 to 120 minutes
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 21 Aug 2026.
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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.
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 Sulfate 2 grams, Magnesium Sulfate 4 G and Paracetamol 1 g in people with Acute Headache and Migraine, 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 8 inclusion and 7 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 21 Aug 2026. 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. 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?
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 (73106046 ext. 00216, semir.nouira@rns.tn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity at 60 Minutes (time frame: 60 minutes). The study lists 2 primary outcomes in all. 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 21 Aug 2026.