Does Nerve Block + Oral Dexamethasone Reduce Recurrence of Headache Within 72 Hrs?

NCT06016465 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: E23081
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

For some patients who come to the emergency department for treatment of a migraine headache, peripheral headache nerve blocks (PHNB) have proven to be an efficient and effective treatment for headache relief. Previous studies have demonstrated that adding steroids as an adjunct treatment to standard migraine treatment can reduce recurrence of headaches in the subsequent few days.

Conditions

Migraine

Keywords

migraine headache; peripheral nerve block; dexamethasone; steroid treatment

Outcome Measures

Primary Outcomes (1)

• Recurrence of headache

  Subjects will be contacted 72 hrs post treatment to determine if migraine headache has recurred

  72-96 hours post treatment

Secondary Outcomes (2)

• Early recurrence headache and timing

  72-96hrs post treatment

• side effects of dexamethasone identified if any

  72-96 hrs post treatment

Study Arms (2)

Dexamethasone

EXPERIMENTAL

single oral dose of dexamethasone (8mg)

Drug: Dexamethasone Oral

Placebo

PLACEBO COMPARATOR

Single oral dose of placebo pill

Drug: Placebo

Interventions

Dexamethasone Oral DRUG

Two 4mg pills

Also known as: Decadron

Dexamethasone

Placebo DRUG

2 placebo pills

Also known as: Dextrose methyl cellulose

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet ICHD-3 Migraine Headache Criteria
• Had a minimum 5-point reduction in headache intensity after nerve block(s) or post- block pain score of 0 to 2
• Nerve block performed with bupivacaine 0.5%

You may not qualify if:

• Head trauma
• Suspicion of secondary headache (i.e. stroke, known tumor, glaucoma)
• Headache in the setting of viral syndrome
• Chronically on steroids
• Known allergy to dexamethasone
• Unable to reach the patient by phone or text for follow-up
• Gestational diabetes or other uncontrolled diabetes
• Known to be immunocompromised

Sponsors & Collaborators

• Texas Tech University Health Sciences Center, El Paso: lead

Study Sites (1)

University Medical Center of El Paso

El Paso, Texas, 79905, United States

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Interventions

Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Susan Watts, PhD.

  Texas Tech University Health Sciences Center, Department of Emergency Medicine

  STUDY DIRECTOR

• Diluma Kariyawasam, MPH

  Texas Tech University Health Sciences Center, El Paso

  STUDY DIRECTOR

Central Study Contacts

Edward Michelson, MD

CONTACT

915 215 4600; edward.michelson@ttuhsc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: study drug pills (dexamethasone or placebo) will be placed in identical colored capsules and then into numbered packets. Only pharmacist will be unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair Dept of Emergency Medicine

Model Details: Randomized 1:1 for study drug vs placebo

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 29, 2023
• Study Start: September 15, 2023
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)