ClinicalTrials.gg
RecruitingNCT06016465Updated May 6, 2026

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

An Early Phase 1 interventional study of Dexamethasone Oral and Placebo in Migraine, sponsored by Texas Tech University Health Sciences Center, El Paso. Recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by Texas Tech University Health Sciences Center, El Paso · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years 1 month later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 696 studies in Migraine Disorders with a site in United States — 93 open to participants now, 115 under way, 27 of them phase 3. Migraine Disorders · United States.

Planned enrollment
292nd of 609
84 · median 78
Started
2023
with 37 others
Phase 1
58 of 696
6 open now
Primary completion
2027-12
later than 66 of 114 live
Registered
578th of 696
by date

Among the 696 studies in Migraine Disorders with a site in United States, this one is the 292nd largest by planned enrollment of the 609 interventional ones that give a count, is one of 38 that started in 2023, is one of 58 in phase 1, reaches primary completion later than 66 of the 114 other live ones, and was the 578th registered.

Migraine Disorders

1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.

Browse Migraine Disorders studies →

Open to participants now

93 of the 696 studies in Migraine Disorders with a site in United States are open now. Recruiting first, the newest first:

88 more — sign in →

All 93 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 216 Migraine Disorders studies recruiting now, 65 (30%) set no upper age limit and 136 (63%) stop at 75 or younger; 44 take children under 18; 36 take healthy volunteers.

This study: 18 Years to 85 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 696 studies in Migraine Disorders with a site in United States, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Migraine

Browse trials for

Keywords

  • migraine headache
  • peripheral nerve block
  • dexamethasone
  • steroid treatment
04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Head trauma
  • Suspicion of secondary headache (i.e. stroke, known tumor, glaucoma)
  • Headache in the setting of viral syndrome
  • Chronically on
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
84 participants (estimated)

Study arms

  • Experimental
    Dexamethasone

    single oral dose of dexamethasone (8mg)

    Drug: Dexamethasone Oral

  • Placebo comparator
    Placebo

    Single oral dose of placebo pill

    Drug: Placebo

Interventions

  • Two 4mg pills

    Also known as: Decadron

  • DrugPlacebo

    2 placebo pills

    Also known as: Dextrose methyl cellulose

06

What researchers measure

Primary outcomes

  1. Recurrence of headache

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

    Time frame: 72-96 hours post treatment

Secondary outcomes

  1. Early recurrence headache and timing

    HA severity, location, time since enrollment enrollment,medications

    Time frame: 72-96hrs post treatment

  2. side effects of dexamethasone identified if any

    elevation in glucose level, other symptoms associated with corticosteroids

    Time frame: 72-96 hrs post treatment

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2023 (actual). Primary completion is estimated for Dec 2027, 51 months after the start.

Of 53 phase 1 interventional studies under Migraine Disorders, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 19. This study's planned 51 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 21, 2023
First posted
Aug 29, 2023
StartActual
Sep 15, 2023
Primary completionEst.
Dec 30, 2027
CompletionEst.
Jan 30, 2028
Last update
May 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06016465
Lead sponsor
Texas Tech University Health Sciences Center, El Paso
Responsible party
Edward Michelson, MD (Professor and Chair Dept of Emergency Medicine, Texas Tech University Health Sciences Center, El Paso) — Principal investigator
First posted
Aug 29, 2023
Start date
Sep 15, 2023
Primary completion
Dec 30, 2027 (estimated)
Completion
Jan 30, 2028 (estimated)
Last update
May 6, 2026

Study contacts

Edward Michelson, MD
Contact
edward.michelson@ttuhsc.edu
915 215 4600
Susan Watts, PhD.
study director · Texas Tech University Health Sciences Center, Department of Emergency Medicine
Diluma Kariyawasam, MPH
study director · Texas Tech University Health Sciences Center, El Paso

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Dexamethasone

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