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

• ClinicalTrials.gov Identifier: NCT06016465
• Recruitment Status: Recruiting
• First Posted: August 29, 2023
• Last Update Posted: September 28, 2023
• Sponsor: Texas Tech University Health Sciences Center, El Paso
• Information provided by (Responsible Party): Edward Michelson, MD, Texas Tech University Health Sciences Center, El Paso

Tracking Information

• First Submitted Date: August 21, 2023
• First Posted Date: August 29, 2023
• Last Update Posted Date: September 28, 2023
• Actual Study Start Date: September 15, 2023
• Estimated Primary Completion Date: August 30, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 24, 2023)

Recurrence of headache [ Time Frame: 72-96 hours post treatment ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 24, 2023)

• Early recurrence headache and timing [ Time Frame: 72-96hrs post treatment ]
  HA severity, location, time since enrollment enrollment,medications
• side effects of dexamethasone identified if any [ Time Frame: 72-96 hrs post treatment ]
  elevation in glucose level, other symptoms associated with corticosteroids

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Does Nerve Block + Oral Dexamethasone Reduce Recurrence of Headache Within 72 Hrs?
• Official Title: Does Nerve Block Plus Oral Dexamethasone Reduce Recurrence of Headache Within 72 Hours Better Than Nerve Block Alone?
• 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.

Detailed Description

Previous studies have provided evidence that administering steroids in addition to standard migraine headache treatment in the emergency department may reduce the recurrence of the headache within 24-72 hours. The standard migraine treatments in previous studies have been varied and include 5-HT receptor agonists, dopamine antagonists, dihydroergotamine, NSAIDS, and opioid analgesics. The steroids added to the standard treatment have been prednisone and dexamethasone (both IV and oral).

This is the first study to examine the combination of peripheral nerve block as the primary treatment of migraine followed by oral dexamethasone to prevent recurrence.

• Study Type: Interventional
• Study Phase: Early Phase 1

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized 1:1 for study drug vs placebo

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

study drug pills (dexamethasone or placebo) will be placed in identical colored capsules and then into numbered packets. Only pharmacist will be unblinded.

Primary Purpose: Treatment

• Condition: Migraine

Intervention

• Drug: Dexamethasone Oral
  Two 4mg pills
  Other Name: Decadron
• Drug: Placebo
  2 placebo pills
  Other Name: Dextrose methyl cellulose

Study Arms

• Experimental: Dexamethasone
  single oral dose of dexamethasone (8mg)
  Intervention: Drug: Dexamethasone Oral
• Placebo Comparator: Placebo
  Single oral dose of placebo pill
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 24, 2023): 84
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 10, 2024
• Estimated Primary Completion Date: August 30, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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%

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Edward Michelson, MD; 915 215 4600; edward.michelson@ttuhsc.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06016465
• Other Study ID Numbers: E23081
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Edward Michelson, MD, Texas Tech University Health Sciences Center, El Paso
• Original Responsible Party: Same as current
• Current Study Sponsor: Texas Tech University Health Sciences Center, El Paso
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Susan Watts, PhD.; Texas Tech University Health Sciences Center, Department of Emergency Medicine

• PRS Account: Texas Tech University Health Sciences Center, El Paso
• Verification Date: September 2023