Safety and Efficacy Trial of MTX101 2mg for the Acute Treatment of Migraine in Adults (NCT06728553) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy Trial of MTX101 2mg for the Acute Treatment of Migraine in Adults
United States78 participantsStarted 2025-02-24
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male or female aged 18 to 65 years at the time of consent.
✓. Onset of migraine headache before age 50.
✓. History of episodic migraine headache starting at least 1-year ago with or without aura.
✓. Has a minimum of 4 monthly migraine days and not more than 10 migraine days per month.
✓. Able to distinguish pain related to migraine attacks from tension-type and cluster headache attacks.
✓. Able to understand and provide signed informed consent.
✓. Willing and able to comply with all scheduled visits, treatment plan, and other study procedures.
Exclusion criteria
✕. No more than a total of 15 headache days per month.
✕. Use of more than 2 migraine preventive medications.
✕. Current diagnosis of glaucoma.
What they're measuring
1
Safety assessment (occurrence of adverse events, treatment emergent adverse events and serious adverse events).
Timeframe: Treatment emergent adverse event safety assessments will be limited to the first 48 hours after a treated attack.
✕. Use of opioids or barbiturates more than 4 days/month, triptans or ergots 10 or more days/month, or simple analgesics (e.g., aspirin, NSAIDs, acetaminophen) 15 or more days/month in the 3 months prior to Visit 1.
✕. Current diagnosis of any post-traumatic headaches, medication overuse headaches, new daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), painful cranial neuropathy or daily headaches.
✕. Vaccination within less than 7 days from the Screening or plans to get a vaccine during the study or within a week after final study dose.