Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Manistee Therapeutics
Subjects enrolled in the study will be randomized to receive investigational product (MTX101 2mg or placebo), to be taken as soon as they have a migraine headache that reaches moderate to severe intensity. Subjects will take a single dose of either active or placebo to treat one migraine headache. Rescue medication should not be taken until at least 2 hours post study medication dose.
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.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
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.
You may not be if
1. No more than a total of 15 headache days per month.
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.
Clareo Health | Safety and Efficacy Trial of MTX101 2mg for the Acute Treatment of Migraine in Adults
