NCT07313800Withdrawn
EMBRACE Study: Enduring Migraine Benefit From Responsive Artery Coil Embolization
Enduring Migraine Benefit From Responsive Artery Coil Embolization (EMBRACE): A Single-Site, Non-Significant Risk Pilot Study of Middle Meningeal Artery Embolization Using FDA-Cleared Coils for Refractory Episodic Migraine
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Reason given: The study was not initiated. IRB review determined the study would require an investigational device exemption (IDE), and the sponsor elected not to proceed because resources were not available. No subjects were enrolled.
Brief summary (registry, in English)
This single-site, open-label pilot study evaluates the safety, feasibility, and potential durability of the TEMMA procedure (Targeted Embolization for Migraine Management), an endovascular treatment strategy targeting meningeal arterial contributors to migraine. Adults aged 18-60 with refractory migraine despite prior preventive therapies are eligible. The study assesses migraine outcomes over 12 months using patient-reported headache frequency, pain intensity, acute medication use, migraine-related disability (MIDAS), and quality-of-life measures (MSQ v2.1).
- Status (registry)
- Withdrawn
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 30 Dec 2025
- Start date
- 1 Mar 2028
- Primary completion date
- 1 Mar 2030
- Lead sponsor
- Cortex Neurovascular
- Diseases
- Migraine
- NCT number
- NCT07313800
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior MMA embolization
Other illness
- Secondary headache disorders
Other
- Contraindication to angiography or embolization
- Pregnancy
- Inability to comply with follow-up
Who the study is looking for
- Age 18-60 years
- Diagnosis of migraine (with or without aura)
- -≥8 headache days per month
- Failure of ≥2 preventive medication classes
- Ability to complete electronic headache diary and surveys
- Ability to provide informed consent
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cortex Neurovascular / TRA Union | Tacoma | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.