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

Phase 2

Waitlist Available

Research Sponsored by Manistee Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

1. Male or female aged 18 to 65 years at the time of consent.

2. Onset of migraine headache before age 50.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up treatment emergent adverse event safety assessments will be limited to the first 48 hours after a treated attack.

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Migraine

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ treatment emergent adverse event safety assessments will be limited to the first 48 hours after a treated attack.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~treatment emergent adverse event safety assessments will be limited to the first 48 hours after a treated attack.

This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment emergent adverse event safety assessments will be limited to the first 48 hours after a treated attack. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety assessment (occurrence of adverse events, treatment emergent adverse events and serious adverse events).

Secondary study objectives

The change in migraine headache pain score, using an 11-point Numerical Rating Scale, (0=no pain, 10=worst possible pain).

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 8Eligibility criteria met