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Nerve block or antidepressant? study tests two migraine treatments Head-to-Head

NCT ID NCT02090998

Symptom relief Sponsor: Rutgers, The State University of New Jersey Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two treatments for transformed migraine (chronic daily headache): a sphenopalatine ganglion nerve block using lidocaine gel applied inside the nose, versus daily oral amitriptyline (Elavil), an antidepressant often used for migraine prevention. Ten adults aged 18 to 90 with a formal migraine diagnosis are randomly assigned to one of the two groups. The goal is to see which approach better reduces the number and severity of daily headaches.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lidocaine gel and amitriptyline
What this could lead to
If one method proves more effective, it could offer a better option for managing chronic migraines with fewer side effects.
What could go wrong
This is a very small early-phase study with only 10 participants, so results may not apply widely. Both treatments have known side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

10 people

The number who actually took part.

Start date

May 2014

Finished

Mar 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male and female age 18-90 2. Subject have formal medical diagnosis of migraine headache 3. Subjects currently require treatment for headache 4. Subjects who have received optimal medical management from migraines including triptans (Imitrex, Amerge and Relpax) 5. Subjects who have recieved optimal medical management for migraines including anticonvulsants (Depakote, Lamictal, klonopin Exclusion Criteria: 1. Less than 18 years of age 2. Subjects will be excluded if they are already being treated with lidocaine (patch or other vehicle) for chronic pain 3. Untreated Heart Failure 4. Pregnancy 5. Individuals unwilling to comply with study procedures and follow-up

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Conditions

The condition(s) this trial relates to.

headache disorder migraine disorder temporal lobe epilepsy Vascular Headaches

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic daily headache Transformed migraine

Contacts and locations

Locations

  • Rutgers, Robert Wood Johnson Medical School , Pain Center of NJ

    New Brunswick, New Jersey, 08901, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.