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

NCT06728553 | Completed Phase 2 FDA Drug

• 1 other identifier: MTX101-0202 / Pro00082158
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Migraine

Keywords

acute treatment of migraine; nervous system diseases; central nervous system diseases; brain diseases; headache; migraine with or without aura

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The 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.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Active

EXPERIMENTAL

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

Interventions

MTX101 DRUG

One 2 mg sublingual tablet of MTX101

Active

Placebo DRUG

One sublingual tablet of placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18 to 65 years at the time of consent.
• Onset of migraine headache before age 50.
• History of episodic migraine headache starting at least 1-year ago with or without aura.
• Has a minimum of 4 monthly migraine days and not more than 10 migraine days per month.
• Able to distinguish pain related to migraine attacks from tension-type and cluster headache attacks.
• Able to understand and provide signed informed consent.
• Willing and able to comply with all scheduled visits, treatment plan, and other study procedures.

You may not qualify if:

• No more than a total of 15 headache days per month.
• Use of more than 2 migraine preventive medications.
• Current diagnosis of glaucoma.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Manistee Therapeutics: lead

Study Sites (7)

Kaizen Brain Center

La Jolla, California, 92037, United States

Location

Clinical Research Institute, LLC

Santa Monica, California, 90048, United States

Location

Brainstorm Research

Miami, Florida, 33176, United States

Location

Synergy Clinical Research/Emerald Coast Center for Neurological Disorders

Pensacola, Florida, 32504, United States

Location

DelRicht Research

New Orleans, Louisiana, 70115, United States

Location

QUEST Research Institute

Farmington Hills, Michigan, 48334, United States

Location

Wasatch Clinical Research

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Nervous System Diseases; Central Nervous System Diseases; Brain Diseases; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chief Medical Officer

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 11, 2024
• Study Start: February 24, 2025
• Primary Completion: June 27, 2025
• Study Completion: July 28, 2025
• Last Updated: October 7, 2025

Record last verified: 2025-10

Locations

US (7)