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
Abstract
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.
Primary outcome: Safety assessment (occurrence of adverse events, treatment emergent adverse events and serious adverse events)..
Enrollment: 78 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 78 participants or records.
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