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

NCT06728553 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2025-10-07

No results posted yet for this 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.

Conditions

Interventions

DRUG

MTX101

One 2 mg sublingual tablet of MTX101

DRUG

Placebo

One sublingual tablet of placebo

Sponsors & Collaborators

  • Manistee Therapeutics

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-24
Primary Completion
2025-06-27
Completion
2025-07-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06728553 on ClinicalTrials.gov