Nerve Block + Dexamethasone for Migraine

Recruiting at 1 trial location

Overseen By Edward Michelson, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Texas Tech University Health Sciences Center, El Paso

Must not be taking: Steroids

Disqualifiers: Head trauma, Secondary headache, Diabetes, others

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: 73

Duration: 1 day

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding dexamethasone, a steroid, to standard nerve block treatment can reduce migraine headaches and prevent their quick return. Participants will receive either dexamethasone or a placebo to determine which is more effective. The researchers seek individuals who have experienced significant migraine pain reduction after a nerve block to join the study. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to contribute to groundbreaking migraine research.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are chronically on steroids, you cannot participate in the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that dexamethasone is generally a safe option for treating migraines. Studies have found it more effective than a placebo in reducing the likelihood of a migraine returning, resulting in fewer headaches after the initial treatment.

Most people tolerate dexamethasone well, though it can have side effects like any medication. These side effects are usually mild and may include an upset stomach or trouble sleeping.

This trial uses a single dose of 8 mg dexamethasone, considered low. Previous research with various doses has not reported serious side effects, indicating that this treatment is well-tolerated at this dose.

Overall, the evidence supports dexamethasone's safety in preventing migraines from recurring. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for migraine?

Researchers are excited about the use of dexamethasone for migraines because, unlike most current treatments that focus on relieving pain through vasoconstriction or reducing inflammation, dexamethasone is a corticosteroid that reduces inflammation through a different pathway. It is administered orally and may offer a new option for those who don't respond well to typical migraine medications like triptans or NSAIDs. Additionally, the combination of dexamethasone with nerve block techniques could provide a more comprehensive approach to migraine relief, potentially leading to longer-lasting effects.

What evidence suggests that this trial's treatments could be effective for migraine?

Research has shown that dexamethasone, which participants in this trial may receive, can help reduce migraine recurrence. One study found that people who took dexamethasone had a 26% lower chance of their migraine returning compared to those who didn't take it. Another study reported that about 34% of patients experienced significant headache relief with dexamethasone. In some severe cases, it improved pain for 80% of patients. These findings suggest that dexamethasone may help manage migraines and reduce their frequency. ^{3 5 6 7 8}

Who Is on the Research Team?

Susan Watts, PhD.

Principal Investigator

Texas Tech University Health Sciences Center, Department of Emergency Medicine

Are You a Good Fit for This Trial?

This trial is for individuals who meet the criteria for migraine headaches and have experienced significant relief after a nerve block treatment. They must not have head trauma, suspicion of secondary headache causes like stroke or tumors, be chronically on steroids, have allergies to dexamethasone, uncontrolled diabetes, or compromised immune systems.

Inclusion Criteria

I have had a nerve block with a specific medication.

My headache pain decreased significantly after a nerve block.

I have been diagnosed with migraines according to ICHD-3 standards.

Exclusion Criteria

You are allergic to dexamethasone.

Known to be immunocompromised

I have headaches with symptoms of a viral infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive a peripheral nerve block followed by a single oral dose of dexamethasone or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for recurrence of headache and side effects of dexamethasone

1 week

Contact at 72-96 hours post treatment

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone
• Placebo

Trial Overview The study tests if adding oral dexamethasone to a peripheral headache nerve block can prevent the recurrence of migraines within 72 hours post-treatment. Participants will either receive dexamethasone or a placebo alongside their usual migraine management.

How Is the Trial Designed?

Group I: Dexamethasone Experimental Treatment 1 Intervention

single oral dose of dexamethasone (8mg)

Group II: Placebo Placebo Group 1 Intervention

Single oral dose of placebo pill

Who Is Running the Clinical Trial?

Texas Tech University Health Sciences Center, El Paso

Lead Sponsor

Trials

51

Recruited

5,800+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10573135/

Randomized Trial Comparing Low- vs High-Dose IV ... We hypothesized that dexamethasone 16 mg IV would allow greater rates of sustained headache relief than 4 mg when coadministered with metoclopramide 10 mg IV.

2. thennt.com thennt.com/nnt/steroids-for-prevention-of-migraine-recurrence/

Steroids for Prevention of Migraine Recurrence Dexamethasone was more effective than placebo in reducing recurrence rates (relative risk 0.74, 95% confidence interval 0.60 to 0.90), despite ...

3. jwatch.org jwatch.org/na56605/2023/10/04/dexamethasone-dose-migraine-treatment-emergency-department

Dexamethasone Dose for Migraine Treatment in the ... Sustained headache relief, defined as residual headache intensity of “none” or “mild,” was achieved in 34% (35 of 102) of patients receiving 4 ...

4. neurology.org neurology.org/doi/10.1212/WNL.86.16_supplement.P1.160

Treatment of Status Migrainosus with Oral Dexamethasone ... Oral dexamethasone at 4 mg BID for four days showed significant improvement in pain levels in 80[percnt] of patients with status migrainosus treated in an ...

5. neurologyadvisor.com neurologyadvisor.com/news/can-high-dose-dexamethasone-improve-migraine-outcomes-after-ed-discharge/

Can High-Dose Dexamethasone Improve Migraine ... Sustained headache relief after discharge occurred in 35 of 102 (34%) patients in the low-dose dexamethasone group and 42 of 102 (41%) patients ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37604662/

vs High-Dose IV Dexamethasone for Patients With Moderate ... This study provides Class I evidence that 16 mg of IV dexamethasone is unlikely to provide greater rates of sustained headache relief than 4 ...

7. neurology.org neurology.org/doi/10.1212/WNL.0000000000207648

Randomized Trial Comparing Low- vs High-Dose IV ... This study provides Class I evidence that 16 mg of IV dexamethasone is unlikely to provide greater rates of sustained headache relief than 4 mg of IV ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10662276/

Steroids in Headache: A Comprehensive Review of Recent ... Nineteen studies (76%) showed favoring benefits of corticosteroid in outcome benefits; non-inferior outcomes with corticosteroids were shown in six (24%) ...