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

Description

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.

Conditions

Migraine

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Study Overview

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Study Details

Study overview

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.

A Pilot, Phase 2a, Randomized, Double-blind, Placebo-controlled, Cross-over Clinical Study to Evaluate Safety and Efficacy of Sublingual MTX101 for the Acute Treatment of Migraine Headaches in Adults

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

Condition
Migraine
Intervention / Treatment

-

Contacts and Locations

La Jolla

Kaizen Brain Center, La Jolla, California, United States, 92037

Santa Monica

Clinical Research Institute, LLC, Santa Monica, California, United States, 90048

Miami

Brainstorm Research, Miami, Florida, United States, 33176

Pensacola

Synergy Clinical Research/Emerald Coast Center for Neurological Disorders, Pensacola, Florida, United States, 32504

Farmington Hills

QUEST Research Institute, Farmington Hills, Michigan, United States, 48334

Salt Lake City

Wasatch Clinical Research, Salt Lake City, Utah, United States, 84107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Manistee Therapeutics,

Chief Medical Officer, STUDY_DIRECTOR, Sponsor GmbH

Study Record Dates

2025-06