Testing MTX101 for treating acute migraine attacks in adults
A Pilot, Phase 2a, Randomized, Double-blind, Placebo-controlled, Cross-over Clinical Study to Evaluate Safety and Efficacy of Sublingual MTX101 for the Acute Treatment of Migraine Headaches in Adults
This study is testing if a new drug called MTX101 can help adults with migraine attacks feel better and need less medication during their headaches.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Manistee Therapeutics Industry-sponsored |
| Locations | 7 sites (La Jolla, California and 6 other locations) |
| Trial ID | NCT06728553 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of MTX101, a drug designed for the acute treatment of migraine attacks in adults. Participants will be randomly assigned to receive either MTX101 or a placebo during a migraine episode, and their headache pain levels and need for rescue medication will be monitored. The study involves two clinic visits and a follow-up phone call over a four-week period, during which participants will also maintain a diary of their symptoms. The primary focus is to determine if MTX101 effectively reduces headache pain compared to a placebo.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a history of episodic migraines and a minimum of 4 migraine days per month.
Not a fit: Patients with chronic migraine conditions or those using multiple preventive medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for adults suffering from acute migraine attacks.
How similar studies have performed: Other studies have shown promise in treating migraines with similar approaches, but the specific efficacy of MTX101 remains to be established.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: 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. Key Exclusion Criteria: 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.
Where this trial is running
La Jolla, California and 6 other locations
- Kaizen Brain Center — La Jolla, California, United States (Recruiting)
- Clinical Research Institute, LLC — Santa Monica, California, United States (Recruiting)
- Brainstorm Research — Miami, Florida, United States (Recruiting)
- Synergy Clinical Research/Emerald Coast Center for Neurological Disorders — Pensacola, Florida, United States (Not_yet_recruiting)
- DelRicht Research — New Orleans, Louisiana, United States (Recruiting)
- QUEST Research Institute — Farmington Hills, Michigan, United States (Recruiting)
- Wasatch Clinical Research — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Chief Medical Officer
- Email: info@manisteetx.com
- Phone: 1-866-716-2811
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.