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Headaches Associated With Subarachnoid Hemorrhage (SAH)Phase 2LIMSAHNCT07054801

IA Lidocaine and Methylprednisolone for Headache Associated With Subarachnoid Hemorrhage

A Phase 2 study testing Lidocaine hydrochloride and Methylprednisolone sodium succinate in people with Headaches Associated With Subarachnoid Hemorrhage (SAH), run by Daniel Raper, MBBS at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Subarachnoid hemorrhage (SAH) is a type of bleeding around the brain that can cause sudden and severe headaches. These headaches can be debilitating and persist for weeks, significantly impacting a patient's comfort and recovery. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lidocaine hydrochloride and Methylprednisolone sodium succinate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
23 Jun 2026to 1 Jun 2027
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

  • Adults aged ≥18 years with confirmed SAH via computed tomography or magnetic resonance imaging
  • Undergoing DSA as part of routine diagnostic or therapeutic care
  • Experiencing headaches with baseline severity assessable using Headache Impact Test (HIT-6) questionnaire and 11-point Numeric Rating Scale (NRS)
  • Conscious patients who can understand and sign informed consent form
  • Hemodynamically stable and suitable for intra-arterial procedures
  • 5) Willingness to comply with study procedures and follow-ups

Who cannot join

  • Known allergy or hypersensitivity to lidocaine or amide-type anesthetics
  • Known allergy or hypersensitivity to Intralipid® (intravenous fat emulsion) or any of its components, including egg phospholipids or soy-based products
  • Known allergy or hypersensitivity to methylprednisolone, corticosteroids, any component of the Solu-Medrol® formulation
  • Diagnostic abnormalities at baseline, including ECG abnormalities (e.g., prolonged PR/QTc intervals, heart block, arrhythmias)
  • Cardiac conditions including history of heart block, Stokes-Adams syndrome, Wolff-Parkinson-White syndrome, or use of antiarrhythmics
  • Steroid-induced psychiatric history; uncontrolled seizures; uncontrolled diabetes; glaucoma/ocular hypertension; current/recent high-dose systemic steroids.
Show all 18Show fewer
  • Previous IA lidocaine or methylprednisolone (or similar) therapy prior to enrollment
  • Alternative headache etiology (e.g., migraines, tension-type headache)
  • Unable to report pain reliably due to severe cognitive or communication deficits
  • Severe hemodynamic instability precluding safe DSA participation
  • Contraindications to IA catheterization or DSA (e.g., severe peripheral vascular disease, contrast allergies)
  • Severe renal impairment (eGFR <30 mL/min/1.73 m²)
  • Severe hepatic impairment (e.g., Child-Pugh Class C)
  • Active systemic infections
  • Severe comorbid conditions with life expectancy <30 days
  • Participants who are pregnant or breastfeeding
  • Conditions or concomitant medications listed in the USPI for study drugs that would compromise safety or data quality
  • Current participation in another clinical trial

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Daniel M S Raper, MBBS contact

408-347-4046

daniel.raper@ucsf.edu

Atakan Orscelik, MD contact

415-353-7500

atakan.orscelik@ucsf.edu

United States1 site, 1 recruiting
  • University of California, San Francisco

    San Francisco, California, 94143

    Daniel M S Raper, MBBS, 408-347-4046, daniel.raper@ucsf.edu

    Atakan Orscelik, MD, 415-353-7500, atakan.orscelik@ucsf.edu

    Recruiting

Other trials in United States

About this study

Official title: Intra-arterial Lidocaine and Methylprednisolone Injection Into the Middle Meningeal Artery For Treatment of Headache Associated With Subarachnoid Hemorrhage

Subarachnoid hemorrhage (SAH) is a type of bleeding around the brain that can cause sudden and severe headaches. These headaches can be debilitating and persist for weeks, significantly impacting a patient's comfort and recovery. Many patients require opioids for pain control, which can lead to side effects such as drowsiness, constipation, and dependency. There is a need for new treatment strategies to help relieve this pain while minimizing side effects.

This clinical study is designed to evaluate whether an injection of two medications (lidocaine and methylprednisolone) directly into the middle meningeal artery (MMA) can help reduce headache severity in patients who recently experienced a SAH. The medications will be given through a minimally invasive procedure performed during a routine angiogram, a type of imaging test already commonly used in SAH patients. The main goals of the study are to determine whether this treatment approach is safe, helps to reduce the severity of headaches, and decreases the need for opioid pain medications. Eligible patients will be those recently diagnosed with persistent headache symptoms and SAH who are undergoing routine cerebral angiogram, during which the medications are infused into the MMA. Participants will be monitored for pain levels using the Headache Impact Test (HIT-6) and 11-point Numeric Rating Scale (NRS), and for changes in their functional recovery using standard neurologic scales. The results of this study may provide early evidence to support new treatment options for patients suffering from difficult-to-control headaches after a SAH.

Read the detailed description

This is a single-center, prospective, single-arm, open-label clinical trial evaluating the safety and efficacy of intra-arterial administration of lidocaine and methylprednisolone sodium succinate via the MMA for the treatment of moderate or severe headaches associated with SAH. Eligible participants will include adult patients diagnosed with SAH who are undergoing diagnostic or therapeutic digital subtraction angiography (DSA). During the DSA procedure, following routine angiographic imaging, a microcatheter will be placed in the MMA, and a low dose of lidocaine and methylprednisolone will be slowly infused under fluoroscopic guidance.

The primary outcome will assess the change in headache severity and intensity using the HIT-6 score and 11-point NRS at baseline (pre-intervention), discharge, and at follow-up visits at days 1-10, Weeks 2, 4 and 12. Secondary outcomes will include reduction in opioid use, neurological outcome measured by the modified Rankin Scale at discharge and follow-up, and the incidence of any adverse events related to the procedure.

Being tested
Lidocaine hydrochloride, Methylprednisolone sodium succinate
Keywords
Headache, Subarachnoid hemorrhage, Lidocaine, Methylprednisolone, Intra-arterial, Middle meningeal artery, Digital subtraction angiography
Medical subject headings
Headache, Subarachnoid Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lidocaine hydrochlorideDrug

    Also called Xylocaine-MPF

    A total of 20 mg injected in 10 mg doses will be administered over 5 min into the frontal and parietal branches of each MMA, resulting in a cumulative dose of 40 mg per MMA. The injection will be performed bilaterally, yielding a total dose of 80 mg per patient.

  • Methylprednisolone sodium succinateDrug

    Also called Solu-MEDROL

    A total of 10 mg were injected over 5 min into the frontal and parietal branches of each MMA, resulting in a cumulative dose of 20 mg per MMA, yielding a total dose of 40 mg per patient.

Study groups in NCT07054801
Study groupRoleWhat they receive
Treatment CohortExperimentalIntra-arterial 80 mg lidocaine and 40 mg methylprednisolone
Receives: Drug: Lidocaine hydrochloride; Drug: Methylprednisolone sodium succinate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Headache Severity

    Headache Impact Test-6 (HIT-6) score from baseline (pre-intervention) to 12 weeks postoperatively. Scores range from 36 (no impact) to 78 (severe impact), with higher scores indicating a greater negative impact.

    Measured: From baseline to 12-week follow-up

Secondary outcomes (4)
  1. Headache intensity

    11-point Numeric Rating Scale (NRS) score from baseline (pre-intervention) to 12 weeks postoperatively. Scores range from 0 (no pain) to 10 (worst possible pain), with higher scores indicating a greater negative impact.

    Measured: From baseline to 12-week follow-up

  2. Opioid Use

    Total opioid use will be recorded during hospital stay and follow-up.

    Measured: From admission to 12-week follow-up

  3. Functional Outcome

    Functional status will be assessed using the modified Rankin Scale at discharge and follow-up. Scores range from 0 (no symptoms) to 6 (death), with lower scores indicating better outcomes.

    Measured: From discharge to 12-week follow-up

  4. Adverse Events Related to Intra-Arterial Injection

    All procedural and post-procedural complications will be monitored, including symptoms of lidocaine toxicity, new neurological deficits, worsening headache, hemodynamic instability, or allergic reactions. Events will be categorized by severity and attribution to the intervention.

    Measured: From discharge to 12-week follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2025
  2. Study start23 Jun 2026
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07054801
Sponsor's protocol ID
23-40755
Acronym
LIMSAH
Status last verified
Jul 2026
First submitted
27 Jun 2025
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Laemmel E, Segal N, Mirshahi M, Azzazene D, Le Marchand S, Wybier M, Vicaut E, Laredo JD. Deleterious Effects of Intra-arterial Administration of Particulate Steroids on Microvascular Perfusion in a Mouse Model. Radiology. 2016 Jun;279(3):731-40. doi: 10.1148/radiol.2015142746. Epub 2016 Jan 13.

    PubMed 26761719
  • Qureshi AI, Bains NK, Bhatti IA, Jani V, Suri MFK, Bhogal P. Intra-arterial lidocaine administration of lidocaine in middle meningeal artery for short-term treatment of subarachnoid hemorrhage-related headaches. Interv Neuroradiol. 2025 Jan 17:15910199241307049. doi: 10.1177/15910199241307049. Online ahead of print.

    PubMed 39819076
  • Diana F, Romoli M, Ricchetti F, Milonia L, Salcuni A, Cirelli C, Ruzza AD, Gaudino C, Iacobucci M, Biraschi F. Lidocaine for headache prevention during chronic subdural hematoma embolization. Interv Neuroradiol. 2026 Feb;32(1):100-103. doi: 10.1177/15910199231198909. Epub 2023 Aug 30.

    PubMed 37649347
  • Fakih R, Ranjini NJ, Gillani SA, Pfeiffer K, Gomez CR, Sirakov A, Suri MFK, Bhogal P, Qureshi AI. Middle Meningeal Artery Lidocaine Infusion for Refractory Migraine: Angiographic Dose Response and 3-Month Outcomes. J Neuroimaging. 2025 Nov-Dec;35(6):e70096. doi: 10.1111/jon.70096.

    PubMed 41185441
  • Qureshi AI, Pfeiffer K, Babar S, Huang W, Lobanova I, Ishfaq MF, French BR, Siddiq F, Gomez CR. Intra-arterial injection of lidocaine into middle meningeal artery to treat intractable headaches and severe migraine. J Neuroimaging. 2021 Nov;31(6):1126-1134. doi: 10.1111/jon.12918. Epub 2021 Aug 13.

    PubMed 34388298
  • Fiorella D, Arthur AS. Middle meningeal artery embolization for the management of chronic subdural hematoma. J Neurointerv Surg. 2019 Sep;11(9):912-915. doi: 10.1136/neurintsurg-2019-014730. Epub 2019 Feb 23.

    PubMed 30798265
  • Catapano JS, Karahalios K, Srinivasan VM, Baranoski JF, Rutledge C, Cole TS, Ducruet AF, Albuquerque FC, Jadhav AP. Chronic headaches and middle meningeal artery embolization. J Neurointerv Surg. 2022 Mar;14(3):301-303. doi: 10.1136/neurintsurg-2021-017602. Epub 2021 Apr 22.

    PubMed 33888570
  • Qureshi AI, Qureshi MH, Khan AA, Suri MF. Effect of intra-arterial injection of lidocaine and methyl-prednisolone into middle meningeal artery on intractable headaches. J Vasc Interv Neurol. 2014 Dec;7(5):69-72.

    PubMed 25566345

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lidocaine hydrochloride and Methylprednisolone sodium succinate in people with Headaches Associated With Subarachnoid Hemorrhage (SAH), run by Daniel Raper, MBBS at 1 site in United States.

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 6 inclusion and 18 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 8 Jul 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 United States. 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.

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 Daniel M S Raper, MBBS (408-347-4046, daniel.raper@ucsf.edu), 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 baseline to 12-week follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07054801, which also lists 8 linked publications.

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 8 Jul 2026.

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