Headaches Associated With Subarachnoid Hemorrhage (SAH)Phase 2MIL-SAHNCT07816159
MMA Infusion of Lidocaine for Treatment of Headache in Patients With Aneurysmal SAH
A Phase 2 study testing Lidocaine hydrochloride and Isotonic saline in people with Headaches Associated With Subarachnoid Hemorrhage (SAH), run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
The purpose of the MIL-SAH trial is to evaluate the efficacy and safety of middle meningeal artery (MMA) lidocaine infusion for the treatment of headache in patients with aneurysmal subarachnoid hemorrhage (SAH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headaches Associated With Subarachnoid Hemorrhage (SAH)
- What is being tested?
- Lidocaine hydrochloride and Isotonic saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Feb 2030
- Phase
- Phase 2
- 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
- Imaging showing a SAH and intracranial aneurysm
- Undergo endovascular therapy within 72 hours*
- Glasgow coma scale (GCS) score of 14-15
- Maximum headache severity of NRS score ≥ 4 at a time > 1 hour after ictus or the ad-ministration of opioids due to headache
Who cannot join
- The patient is unable to understand information provided in the national language or English
- Known allergies to amide-type local anesthetics or iodinated contrast media
- Pregnancy or lactation
- Severe hepatic impairment
- History of epilepsy
- History of chronic opioid use
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- Renal impairment with eGFR < 30 mL/min/1.73m2
- Current treatment with class III antiarrhythmics (e.g. amiodarone)
- Atrioventricular block of II and III degree
- Unsuccessful endovascular aneurysm securement or procedural complications
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Middle Meningeal Artery Infusion of Lidocaine for Treatment of Headache in Patients With Aneurysmal Subarachnoid Hemorrhage
The purpose of the MIL-SAH trial is to evaluate the efficacy and safety of middle meningeal artery (MMA) lidocaine infusion for the treatment of headache in patients with aneurysmal subarachnoid hemorrhage (SAH). The trial aims to determine whether MMA lidocaine infusion reduces headache severity during the first 72 hours following endovascular aneurysm treatment compared with placebo.
Read the detailed description
The MIL-SAH trial is a multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating whether middle meningeal artery (MMA) infusion of lidocaine reduces headache severity in patients with aneurysmal subarachnoid hemorrhage (SAH). Adult patients with SAH undergoing endovascular aneurysm treatment are randomized to receive either bilateral MMA lidocaine infusion or placebo immediately after successful aneurysm securement.
SAH-related headaches are frequently severe, persistent, and difficult to control with current analgesic strategies, which often rely on opioids. Preliminary case series have suggested that MMA lidocaine infusion may reduce headache severity with few adverse effects, but randomized clinical trials to support this is currently lacking. This trial aims to provide robust data on the efficacy and safety of this novel treatment approach.
- Being tested
- Lidocaine hydrochloride, Isotonic saline
- Keywords
- subarachnoid hemorrhage, lidocaine, middle meningeal artery, SAH, MMA, headache
- Medical subject headings
- Subarachnoid Hemorrhage, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine hydrochlorideDrug
Participants will receive lidocaine hydrochloride at a dose of 50 mg per side (10 mg/mL; 5 mL). The infusion is delivered into each MMA over 5 minutes by manual injection, resulting in a total injection time of approximately 10 minutes and a total lidocaine hydrochloride dose of 100 mg. The trial intervention is performed only during the endovascular treatment session. There is no repeated dosing of trial medication.
Isotonic salineDrug
Participants will receive 5 mL of isotonic saline per side. The infusion is delivered into each MMA over 5 minutes by manual injection, resulting in a total injection time of approximately 10 minutes. The trial intervention is performed only during the endovascular treatment session. There is no repeated dosing of trial medication.
| Study group | Role | What they receive |
|---|---|---|
| MMA lidocaine | Experimental | The participants will receive 50 mg of lidocaine in each middle meningeal artery Receives: Drug: Lidocaine hydrochloride |
| MMA isotonic saline | Placebo comparator | The participants will receive isotonic saline in each middle meningeal artery Receives: Drug: Isotonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Severity
Daily maximum headache severity over the first 72 hours following the trial intervention
Measured: From 0 to 72 hours postprocedure
Secondary outcomes (4)
Headache relief
Proportion of participants with headache relief (none to mild headache, NRS≤3) at 2 hours following the trial intervention
Measured: From baseline to 2 hours postprocedure
Opioid consumption
Total opioid consumption (oral morphine equivalents) during the first 72 hours following the trial intervention
Measured: From 0-72 hours postprocedure
Patient global assessment
Patient global assessment (PGA) score at 72 hours following the trial intervention. Participants will be asked to respond to the question, "Overall, how do you feel about your level of headache control since the treatment?" using a 5-point scale (poor, fair, good, very good, or excellent).
Measured: From 0 to 72 hours postprocedure
Adverse Events Related to Intraarterial Lidocaine Injection
Proportion of participants with new onset of facial paresis, facial numbness, diplopia, blurry vision, or dizziness during the first 24 hours following the trial intervention
Measured: From 0 to 24 hours postprocedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headaches Associated With Subarachnoid Hemorrhage (SAH)Studies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasmus Holmboe Dahl, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816159
- Sponsor's protocol ID
- p-2026-22097
- Other IDs
- E-24086-04, Pilot Research Grant, 2026-526092-36-00
- Acronym
- MIL-SAH
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Middle Meningeal Artery Infusion of Lidocaine for Treatment of Headache in Patients With Aneurysmal Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT07816159
- Acronym / sponsor ID
- MIL-SAH / p-2026-22097
- Keywords
- subarachnoid hemorrhage, lidocaine, middle meningeal artery, SAH, MMA, headache
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 11 Sep 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.
The purpose of the MIL-SAH trial is to evaluate the efficacy and safety of middle meningeal artery (MMA) lidocaine infusion for the treatment of headache in patients with aneurysmal subarachnoid hemorrhage (SAH). The trial aims to determine whether MMA lidocaine infusion reduces headache severity during the first 72 hours following endovascular aneurysm treatment compared with placebo.
Detailed description
The MIL-SAH trial is a multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating whether middle meningeal artery (MMA) infusion of lidocaine reduces headache severity in patients with aneurysmal subarachnoid hemorrhage (SAH). Adult patients with SAH undergoing endovascular aneurysm treatment are randomized to receive either bilateral MMA lidocaine infusion or placebo immediately after successful aneurysm securement.
SAH-related headaches are frequently severe, persistent, and difficult to control with current analgesic strategies, which often rely on opioids. Preliminary case series have suggested that MMA lidocaine infusion may reduce headache severity with few adverse effects, but randomized clinical trials to support this is currently lacking. This trial aims to provide robust data on the efficacy and safety of this novel treatment approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MMA lidocaine | Experimental | Drug: Lidocaine hydrochlorideThe participants will receive 50 mg of lidocaine in each middle meningeal artery |
| MMA isotonic saline | Placebo comparator | Drug: Isotonic salineThe participants will receive isotonic saline in each middle meningeal artery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Imaging showing a SAH and intracranial aneurysm
- Undergo endovascular therapy within 72 hours*
- Glasgow coma scale (GCS) score of 14-15
- Maximum headache severity of NRS score ≥ 4 at a time > 1 hour after ictus or the ad-ministration of opioids due to headache
Key exclusion criteria (10 listed)
- The patient is unable to understand information provided in the national language or English
- Known allergies to amide-type local anesthetics or iodinated contrast media
- Pregnancy or lactation
- Severe hepatic impairment
- History of epilepsy
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 |
|---|---|---|
| Lidocaine hydrochlorideParticipants will receive lidocaine hydrochloride at a dose of 50 mg per side (10 mg/mL; 5 mL). The infusion is delivered into each MMA over 5 minutes by manual injection, resulting in a total injection time of approximately 10 minutes and a total lidocaine hydrochloride dose of 100 mg. The trial intervention is performed only during the endovascular treatment session. There is no repeated dosing of trial medication. | Drug | MMA lidocaine |
| Isotonic salineParticipants will receive 5 mL of isotonic saline per side. The infusion is delivered into each MMA over 5 minutes by manual injection, resulting in a total injection time of approximately 10 minutes. The trial intervention is performed only during the endovascular treatment session. There is no repeated dosing of trial medication. | Drug | MMA isotonic saline |
Primary outcome
Headache Severity
Time frame: From 0 to 72 hours postprocedure
Daily maximum headache severity over the first 72 hours following the trial intervention
4 secondary outcomes
Headache relief
Time frame: From baseline to 2 hours postprocedure
Opioid consumption
Time frame: From 0-72 hours postprocedure
Patient global assessment
Time frame: From 0 to 72 hours postprocedure
Adverse Events Related to Intraarterial Lidocaine Injection
Time frame: From 0 to 24 hours postprocedure
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 11 Sep 2026.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine hydrochloride and Isotonic saline in people with Headaches Associated With Subarachnoid Hemorrhage (SAH), run by Copenhagen University Hospital, Rigshospitalet.
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 10 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: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Rasmus H Dahl (35456491 ext. 0045, rasmus.holmboe.dahl@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Severity (time frame: From 0 to 72 hours postprocedure). 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 11 Sep 2026.