MigraineEarly Phase 1NCT06016465
Does Nerve Block + Oral Dexamethasone Reduce Recurrence of Headache Within 72 Hrs?
A Early Phase 1 study testing Dexamethasone Oral in people with Migraine, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Migraine
- What is being tested?
- Dexamethasone Oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2023to 30 Jan 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Medical Center of El Paso
El Paso, Texas, 79905
Leann Rodriguez, (915) 215-4976, rod72863@ttuhsc.edu
Edward A Michelson, MD
About this study
Official title: Does Nerve Block Plus Oral Dexamethasone Reduce Recurrence of Headache Within 72 Hours Better Than Nerve Block Alone?
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.
- Conditions
- Migraine
- Being tested
- Dexamethasone Oral, Placebo
- Keywords
- migraine headache, peripheral nerve block, dexamethasone, steroid treatment
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone OralDrug
Also called Decadron
Two 4mg pills
PlaceboDrug
Also called Dextrose methyl cellulose
2 placebo pills
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | single oral dose of dexamethasone (8mg) Receives: Drug: Dexamethasone Oral |
| Placebo | Placebo comparator | Single oral dose of placebo pill Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of headache
Subjects will be contacted 72 hrs post treatment to determine if migraine headache has recurred
Measured: 72-96 hours post treatment
Secondary outcomes (2)
Early recurrence headache and timing
HA severity, location, time since enrollment enrollment,medications
Measured: 72-96hrs post treatment
side effects of dexamethasone identified if any
elevation in glucose level, other symptoms associated with corticosteroids
Measured: 72-96 hrs post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start15 Sep 2023
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized 1:1 for study drug vs placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center, El Paso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Michelson, MD, Texas Tech University Health Sciences Center, El Paso
- Investigators
- Susan Watts, PhD., Study director, Texas Tech University Health Sciences Center, Department of Emergency MedicineDiluma Kariyawasam, MPH, Study director, Texas Tech University Health Sciences Center, El Paso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016465
- Sponsor's protocol ID
- E23081
- Status last verified
- Apr 2026
- First submitted
- 21 Aug 2023
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Nerve Block Plus Oral Dexamethasone Reduce Recurrence of Headache Within 72 Hours Better Than Nerve Block Alone?
- ClinicalTrials.gov ID
- NCT06016465
- Acronym / sponsor ID
- E23081
- Conditions
- Migraine
- Keywords
- migraine headache, peripheral nerve block, dexamethasone, steroid treatment
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Texas Tech University Health Sciences Center, El PasoUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized 1:1 for study drug vs placebo
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: Dexamethasone Oralsingle oral dose of dexamethasone (8mg) |
| Placebo | Placebo comparator | Drug: PlaceboSingle oral dose of placebo pill |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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%
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone OralAlso: DecadronTwo 4mg pills | Drug | Dexamethasone |
| PlaceboAlso: Dextrose methyl cellulose2 placebo pills | Drug | Placebo |
Primary outcome
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
2 secondary outcomes
Early recurrence headache and timing
Time frame: 72-96hrs post treatment
side effects of dexamethasone identified if any
Time frame: 72-96 hrs post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dexamethasone Oral in people with Migraine, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edward Michelson, MD (915 215 4600, edward.michelson@ttuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of headache (time frame: 72-96 hours post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.