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| Name | Class |
|---|---|
| Society of Vascular and Interventional Neurology | UNKNOWN |
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The goal of this clinical trial is to test whether injecting lidocaine and steroids into two blood vessels of the brain can help treat chronic headaches (migraines).
The main questions this study aims to answer: is this treatment safe for chronic migraine patients?
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Cohort | Experimental | Intra-arterial 80mg lidocaine and 40mg methylprednisolone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine hydrochloride | Drug | Intra-arterial injection of 40mg lidocaine per middle meningeal artery (total 2 arteries) administered one time |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | Reported adverse events classified using MedDRA and CTCAE, including all events, treatment-related events, and any serious adverse event | From treatment to 12-week follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel A Tonetti, MD | The Cooper Health System | Principal Investigator |
| Manisha Koneru, MD | The Cooper Health System | Study Chair |
| Hamza A Shaikh, MD | The Cooper Health System | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cooper University Health Care | Camden | New Jersey | 08103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41608705 | Result | Koneru M, Shaikh HA, Khalife J, Syrow L, Santucci J, Ballout AA, Patel PD, Thomas AJ, Jovin TG, Tonetti DA. Localized Injection of Lidocaine and Glucocorticoid for Refractory Headache Treatment (LIGHT): A Phase 1 Clinical Trial for Safety. Stroke Vasc Interv Neurol. 2025 Oct 29;5(6):e001966. doi: 10.1161/SVIN.125.001966. eCollection 2025 Nov. No abstract available. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 21, 2025 | Jun 6, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 21, 2024 | Jun 6, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D008776 | Methylprednisolone Hemisuccinate |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Methylprednisolone sodium succinate | Drug | Intra-arterial injection of 20mg methylprednisolone per middle meningeal artery (total 2 arteries) administered one time |
|
|
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |