NCT07044648

Brief Summary

The main goal of this study is to find out how well middle meningeal artery coil embolization works for patients with recurrent chronic migraines that are not resolved with medication.

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
15mo left

Started Feb 2026

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Feb 2026Aug 2027

First Submitted

Initial submission to the registry

June 23, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 1, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

February 6, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

June 23, 2025

Last Update Submit

February 4, 2026

Conditions

Keywords

chronic migrainedrug-resistant migraine

Outcome Measures

Primary Outcomes (12)

  • Migraine Disability Assessment (MIDAS)

    The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.

    Baseline

  • Migraine Disability Assessment (MIDAS)

    The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.

    1 Hour Post Procedure

  • Migraine Disability Assessment (MIDAS)

    The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.

    Day 15 Follow Up

  • Migraine Disability Assessment (MIDAS)

    The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.

    Month 3 Follow Up

  • Migraine Disability Assessment (MIDAS)

    The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.

    Month 6 Follow Up

  • Migraine Disability Assessment (MIDAS)

    The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.

    Month 12 Follow Up

  • Migraine Pain Scale

    Migraine pain scale range is 1-10 with a higher indicating severe level of pain.

    Baseline

  • Migraine Pain Scale

    Migraine pain scale range is 1-10 with a higher indicating severe level of pain.

    1 Hour Post Procedure

  • Migraine Pain Scale

    Migraine pain scale range is 1-10 with a higher indicating severe level of pain.

    Day 15 Follow Up

  • Migraine Pain Scale

    Migraine pain scale range is 1-10 with a higher indicating severe level of pain.

    Month 3 Follow Up

  • Migraine Pain Scale

    Migraine pain scale range is 1-10 with a higher indicating severe level of pain.

    Month 6 Follow Up

  • Migraine Pain Scale

    Migraine pain scale range is 1-10 with a higher indicating severe level of pain.

    Month 12 Follow Up

Secondary Outcomes (6)

  • Number of Pain Meds Used Post Procedure

    1 Hour Post Procedure

  • Number of Pain Meds Used Post Procedure

    6 Hours Post Procedure

  • Number of Pain Meds Used Post Procedure

    Day 15 Follow Up

  • Number of Pain Meds Used Post Procedure

    Month 3 Follow Up

  • Number of Pain Meds Used Post Procedure

    Month 6 Follow Up

  • +1 more secondary outcomes

Study Arms (1)

Middle Meningeal Artery Embolization

EXPERIMENTAL

Participants receive middle meningeal artery embolization

Procedure: Middle Meningeal Artery Embolization

Interventions

Middle meningeal artery embolization using particles or coils

Middle Meningeal Artery Embolization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with diagnosis of migraine with or without aura, chronic migraine, unilateral or bilateral, moderate to severe intensity, 4-72 hours, familiar or sporadic, status migrainosus, primary or secondary
  • Patient who failed pharmacologic treatment (at least 2 failed drugs treatment for more than 3 months) or have considerable side effects
  • Patient with diagnosis of migraine and preference for embolization treatment
  • Clinical follow up of at least 3 months

You may not qualify if:

  • Presence of patent middle meningeal artery homolateral to the side of migraine
  • Previous middle meningeal artery embolization for subdural hematoma
  • Previous craniotomy
  • Patients aged 17 years or younger.
  • Incomplete embolization of middle meningeal artery
  • Patient with baseline CTH or MR brain showing baseline intracranial pathology that can explain migraine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Hamad Farhat, MD

    advocate christ medical center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2025

First Posted

July 1, 2025

Study Start

February 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

February 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share