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

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

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.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: Placebo; Drug: MTX101

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Kaizen Brain Center
    • Santa Monica, California, United States, 90048
      • Clinical Research Institute, LLC
  • Florida
    • Miami, Florida, United States, 33176
      • Brainstorm Research
    • Pensacola, Florida, United States, 32504
      • Synergy Clinical Research/Emerald Coast Center for Neurological Disorders
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • DelRicht Research
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Quest Research Institute
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Subjects will be given one sublingual tablet of matching placebo and instructed to take the tablet after the onset of a migraine of moderate to severe intensity.	Drug: Placebo; One sublingual tablet of placebo
Experimental: Active; Subjects will be given one 2 mg sublingual tablet of the investigational product (MTX101) and instructed to take the tablet after onset of a migraine of moderate to severe intensity.	Drug: MTX101; One 2 mg sublingual tablet of MTX101

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessment (occurrence of adverse events, treatment emergent adverse events and serious adverse events).	To assess the tolerability and safety of MTX101. This objective will be measured by assessing the number of unique subjects with deaths, serious adverse events, and moderate and severe adverse events.	Treatment emergent adverse event safety assessments will be limited to the first 48 hours after a treated attack.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in migraine headache pain score, using an 11-point Numerical Rating Scale, (0=no pain, 10=worst possible pain).	This objective will be measured by change in migraine headache pain score, using an 11-point Numerical Rating Scale, (0=no pain, 10=worst possible pain), from the time of dosing (t=0 hour) to 2 hours post-dose as recorded on the subject's Diary.	From the time of dosing (t=0 hour) to 2 hours post-dose.

Collaborators and Investigators

• Sponsor: Manistee Therapeutics
• Investigators: Study Director: Chief Medical Officer, Sponsor GmbH

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2025
• Primary Completion (Actual): June 27, 2025
• Study Completion (Actual): July 28, 2025

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Actual): December 11, 2024

Study Record Updates

• Last Update Posted (Estimated): October 7, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: nervous system diseases; headache; brain diseases; central nervous system diseases; migraine with or without aura; acute treatment of migraine
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Migraine Disorders; Headache; Brain Diseases; Nervous System Diseases; Central Nervous System Diseases
• Other Study ID Numbers: MTX101-0202 / Pro00082158

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No