MTX101 for Migraine

Recruiting at 6 trial locations

Overseen By Chief Medical Officer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Manistee Therapeutics

Must not be taking: Opioids, Barbiturates, Triptans, Ergots

Disqualifiers: Glaucoma, Daily headaches, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

How does the drug MTX101 for migraine differ from other treatments?

The research does not provide specific information about MTX101, but it highlights that recent migraine treatments focus on non-vascular targets, like Lasmiditan, which is a 5-HT1F receptor agonist that avoids vasoconstriction, making it safer for patients with cardiovascular issues. This suggests that MTX101 might also be targeting novel pathways or mechanisms distinct from traditional treatments like triptans. ^{1 2 3 4 5}

What data supports the effectiveness of the drug MTX101 for treating migraines?

Methotrexate (MTX), a component of MTX101, has shown effectiveness in treating certain brain tumors and conditions involving the central nervous system, suggesting it may have potential benefits for migraines, which also involve the nervous system. ^{6 7 8 9 10}

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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take a single dose of MTX101 or placebo to treat a migraine attack

4 weeks

2 visits (in-person), 1 phone call

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 phone call

What Are the Treatments Tested in This Trial?

Interventions

• MTX101

Trial Overview The study tests if MTX101 can reduce headache pain and lessen the need for additional rescue medication in treating acute migraines compared to a placebo. It involves taking the treatment once per migraine attack with follow-up visits and calls.

How Is the Trial Designed?

Group I: Active Experimental Treatment 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Manistee Therapeutics

Lead Sponsor

Trials

1

Recruited

70+

Published Research Related to This Trial

In a study of 57 patients treated with high-dose methotrexate-based chemotherapy, the overall median survival was 51 months, with particularly favorable outcomes for patients younger than 60, where 74% were alive at last follow-up.

Seventeen patients experienced treatment-related neurotoxicity, mostly among those who received whole brain radiotherapy, suggesting that for older patients, it may be safer to avoid this treatment to reduce neurotoxic risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up of high-dose methotrexate-based therapy with and without whole brain irradiation for newly diagnosed primary CNS lymphoma. Gavrilovic, IT., Hormigo, A., Yahalom, J., et al.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Ventriculolumbar perfusion chemotherapy with methotrexate for treating leptomeningeal carcinomatosis: a Phase II Study. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Preradiation high-dose intravenous methotrexate with leucovorin rescue for untreated primary childhood brain tumors. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

The results of surgery, with or without radiotherapy, for primary spinal myxopapillary ependymoma: a retrospective study from the rare cancer network. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Breast cancer leptomeningeal metastasis--the role of multimodality treatment. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Long-term follow-up of high-dose methotrexate-based therapy with and without whole brain irradiation for newly diagnosed primary CNS lymphoma. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Lasmiditan for the treatment of acute migraine: a review and potential role in clinical practice. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Recent developments in 5-HT(1D) agonists. [2005]

8. United States pubmed.ncbi.nlm.nih.gov

Prevention of Migraine. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Therapeutic novelties in migraine: new drugs, new hope? [2022]

10. India pubmed.ncbi.nlm.nih.gov

Optimal Dosing of Lasmiditan in the Management of Acute Migraine Attack: A Systematic Review and Meta-analysis. [2022]