Safety and Efficacy Trial of MTX101 2mg for the Acute Treatment of Migraine in Adults
NCT ID: NCT06728553
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
78 participants
INTERVENTIONAL
2025-02-24
2025-07-28
Brief Summary
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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.
Detailed Description
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The subject will have a telephone check up within 72 to 120 hours after treatment of the first migraine headache.
The subject will treat a 2nd moderate to severe migraine at least 48 hours after the first treated migraine headache.
The subject will return to the clinic for re-evaluation within a 4 week period from the start of the study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Placebo
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.
Placebo
One sublingual tablet of placebo
Active
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.
MTX101
One 2 mg sublingual tablet of MTX101
Interventions
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MTX101
One 2 mg sublingual tablet of MTX101
Placebo
One sublingual tablet of placebo
Eligibility Criteria
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Inclusion Criteria
2. Onset of migraine headache before age 50.
3. History of episodic migraine headache starting at least 1-year ago with or without aura.
4. Has a minimum of 4 monthly migraine days and not more than 10 migraine days per month.
5. Able to distinguish pain related to migraine attacks from tension-type and cluster headache attacks.
6. Able to understand and provide signed informed consent.
7. Willing and able to comply with all scheduled visits, treatment plan, and other study procedures.
Exclusion Criteria
2. Use of more than 2 migraine preventive medications.
3. Current diagnosis of glaucoma.
4. 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.
5. 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.
6. 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.
18 Years
65 Years
ALL
No
Sponsors
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Manistee Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Medical Officer
Role: STUDY_DIRECTOR
Sponsor GmbH
Locations
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Kaizen Brain Center
La Jolla, California, United States
Clinical Research Institute, LLC
Santa Monica, California, United States
Brainstorm Research
Miami, Florida, United States
Synergy Clinical Research/Emerald Coast Center for Neurological Disorders
Pensacola, Florida, United States
DelRicht Research
New Orleans, Louisiana, United States
QUEST Research Institute
Farmington Hills, Michigan, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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MTX101-0202 / Pro00082158
Identifier Type: -
Identifier Source: org_study_id