NCT06728553

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Manistee Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	MTX101	One 2 mg sublingual tablet of MTX101
DRUG	Placebo	One sublingual tablet of placebo

Timeline

• Start date: 2025-02-24
• Primary completion: 2025-06-27
• Completion: 2025-07-28
• First posted: 2024-12-11
• Last updated: 2025-10-07

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study