MTX101 for Migraine
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if MTX101, a new potential drug, can effectively reduce headache pain during acute migraine attacks and decrease the need for additional medication. Researchers compare MTX101 to a placebo, which resembles the real drug but lacks active ingredients, to assess its effectiveness and safety. Participants will take either MTX101 or the placebo for one migraine attack and will track their symptoms and any extra medication used. This trial may suit individuals who have experienced episodic migraines for at least a year, have 4 to 10 migraines a month, and can distinguish between migraine pain and other headaches. As a Phase 2 trial, this research measures MTX101's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does limit the use of certain migraine medications. You cannot use opioids or barbiturates more than 4 days a month, triptans or ergots 10 or more days a month, or simple pain relievers like aspirin more than 15 days a month before starting the trial.
Is there any evidence suggesting that MTX101 is likely to be safe for humans?
Research shows that MTX101 is generally safe for people. Earlier studies found that patients taking MTX101 experienced mild to moderate side effects, while serious side effects were rare. MTX101 is now in a Phase 2 trial, indicating it has already passed initial safety tests in earlier trials. This is promising, but more information from ongoing trials will provide a clearer understanding of its safety.12345
Why do researchers think this study treatment might be promising for migraine?
Unlike most migraine treatments that often use oral pills or injections, MTX101 is unique because it is a sublingual tablet, meaning it dissolves under the tongue for quick absorption. This new delivery method could potentially offer faster relief from migraine symptoms. Researchers are excited about MTX101 because it targets migraines at a moderate to severe intensity level, which can be challenging for current treatments to address effectively. This quick, targeted approach might offer new hope to those who struggle with frequent and debilitating migraines.
What evidence suggests that MTX101 might be an effective treatment for migraines?
Research shows that MTX101, which participants in this trial may receive, might help reduce headache pain in people with sudden migraines. The drug connects to specific parts of immune cells, potentially controlling the swelling that causes migraine pain. Earlier studies suggest MTX101 could lessen the need for additional medications when the first treatment fails. Although more research is needed, initial results are promising for those seeking new ways to manage migraines.35678
Who Is on the Research Team?
Chief Medical Officer
Principal Investigator
Sponsor GmbH
Are You a Good Fit for This Trial?
This trial is for adults who experience acute migraine attacks. Participants must be willing to take MTX101 or a placebo during one migraine attack, visit the clinic twice, have one phone call checkup over four weeks, and keep a diary of symptoms and rescue medication use.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants take a single dose of MTX101 or placebo to treat a migraine attack
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MTX101
Find a Clinic Near You
Who Is Running the Clinical Trial?
Manistee Therapeutics
Lead Sponsor