MTX101 for Migraine

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Manistee Therapeutics

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Chief Medical Officer

Principal Investigator

Sponsor GmbH

Eligibility Criteria

This trial is for adults who experience acute migraine attacks. Participants must be willing to take MTX101 or a placebo during one migraine attack, visit the clinic twice, have one phone call checkup over four weeks, and keep a diary of symptoms and rescue medication use.

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.

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Treatment Details

Interventions

MTX101 (Anti-metabolites)

Trial OverviewThe study tests if MTX101 can reduce headache pain and lessen the need for additional rescue medication in treating acute migraines compared to a placebo. It involves taking the treatment once per migraine attack with follow-up visits and calls.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ActiveExperimental Treatment1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

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.