Safety and Efficacy Trial of MTX101 2mg for the Acute Treatment of Migraine in Adults

Last updated: March 26, 2025
Sponsor: Manistee Therapeutics
Overall Status: Active - Recruiting

Phase

2

Condition

Oral Facial Pain

Pain

Pain (Pediatric)

Treatment

Placebo

MTX101

Clinical Study ID

NCT06728553
MTX101-0202 / Pro00082158
  • Ages 18-65
  • All Genders

Study Summary

The goal of this clinical trial is to learn if drug MTX101 works to treat acute migraine attacks in adults. It will also learn about the safety of the drug MTX101. The main questions it aims to answer are:

Does the drug MTX101 lower headache pain for participants and the need to use a rescue medication? What side effects, if any, do participants have when taking the drug MTX101? Researchers will compare the drug MTX101 to a placebo (a look-alike substance that contains no drug) to see if the drug MTX101 works to treat acute migraine attacks.

Participants will:

Take the drug MTX101 or a placebo to treat 1 migraine attack with each treatment.

Visit the clinic twice and have one phone call over a 4 week period for checkups and tests.

Keep a diary of their symptoms and the number of times they use a rescue medication.

Eligibility Criteria

Inclusion

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 withoutaura.

  4. Has a minimum of 4 monthly migraine days and not more than 10 migraine days permonth.

  5. Able to distinguish pain related to migraine attacks from tension-type and clusterheadache attacks.

  6. Able to understand and provide signed informed consent.

  7. Willing and able to comply with all scheduled visits, treatment plan, and otherstudy procedures.

Exclusion

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 moredays/month, or simple analgesics (e.g., aspirin, NSAIDs, acetaminophen) 15 or moredays/month in the 3 months prior to Visit 1.

  5. Current diagnosis of any post-traumatic headaches, medication overuse headaches, newdaily 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 vaccineduring the study or within a week after final study dose.

Study Design

Total Participants: 72
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
February 24, 2025
Estimated Completion Date:
June 30, 2025

Study Description

Subjects enrolled in the study will be randomized to receive investigational product (MTX101 2mg or placebo), to be taken as soon as they have a migraine headache that reaches moderate to severe intensity. Subjects will take a single dose of either active or placebo to treat one migraine headache. Rescue medication should not be taken until at least 2 hours post study medication dose.

The subject will have a telephone check up within 72 to 120 hours after treatment of the first migraine headache.

The subject will treat a 2nd moderate to severe migraine at least 48 hours after the first treated migraine headache.

The subject will return to the clinic for re-evaluation within a 4 week period from the start of the study.

Connect with a study center

  • Kaizen Brain Center

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Clinical Research Institute, LLC

    Santa Monica, California 90048
    United States

    Active - Recruiting

  • Brainstorm Research

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Synergy Clinical Research/Emerald Coast Center for Neurological Disorders

    Pensacola, Florida 32504
    United States

    Site Not Available

  • DelRicht Research

    New Orleans, Louisiana 70115
    United States

    Active - Recruiting

  • QUEST Research Institute

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

  • Wasatch Clinical Research

    Salt Lake City, Utah 84107
    United States

    Active - Recruiting

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