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New migraine pill under the tongue shows promise in early trial

NCT ID NCT06728553

Symptom relief Sponsor: Manistee Therapeutics 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed Phase 2a trial tested whether a sublingual tablet called MTX101 can safely relieve migraine pain in adults. 78 participants took either the drug or a placebo during a migraine attack and tracked their symptoms. The study measured pain reduction and the need for rescue medication, along with any side effects.

What this could mean

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

Active substance
MTX101 (a sublingual tablet)
What this could lead to
If it works, this could provide a new, fast-acting option for treating migraine headaches as they happen.
What could go wrong
This is an early pilot study with only 78 people, so results may not apply to everyone. The drug may not work better than a placebo, and side effects are still being evaluated.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

78 people

The number who actually took part.

Started

Feb 2025

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 65 years

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.

Key Inclusion Criteria: 1. Male or female aged 18 to 65 years at the time of consent. 2. Onset of migraine headache before age 50. 3. History of episodic migraine headache starting at least 1-year ago with or without aura. 4. Has a minimum of 4 monthly migraine days and not more than 10 migraine days per month. 5. Able to distinguish pain related to migraine attacks from tension-type and cluster headache attacks. 6. Able to understand and provide signed informed consent. 7. Willing and able to comply with all scheduled visits, treatment plan, and other study procedures. Key Exclusion Criteria: 1. No more than a total of 15 headache days per month. 2. Use of more than 2 migraine preventive medications. 3. Current diagnosis of glaucoma. 4. Use of opioids or barbiturates more than 4 days/month, triptans or ergots 10 or more days/month, or simple analgesics (e.g., aspirin, NSAIDs, acetaminophen) 15 or more days/month in the 3 months prior to Visit 1. 5. Current diagnosis of any post-traumatic headaches, medication overuse headaches, new daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), painful cranial neuropathy or daily headaches. 6. Vaccination within less than 7 days from the Screening or plans to get a vaccine during the study or within a week after final study dose.

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Conditions

The condition(s) this trial relates to.

brain disorder central nervous system disorder Headache migraine disorder nervous system disorder

As listed by the trial registrant

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

Migraine

Contacts and locations

Locations

  • Brainstorm Research

    Miami, Florida, 33176, United States

  • Clinical Research Institute, LLC

    Santa Monica, California, 90048, United States

  • DelRicht Research

    New Orleans, Louisiana, 70115, United States

  • Kaizen Brain Center

    La Jolla, California, 92037, United States

  • QUEST Research Institute

    Farmington Hills, Michigan, 48334, United States

  • Synergy Clinical Research/Emerald Coast Center for Neurological Disorders

    Pensacola, Florida, 32504, United States

  • Wasatch Clinical Research

    Salt Lake City, Utah, 84107, United States

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