NCT06728553CompletedPhase 2
Safety and Efficacy Trial of MTX101 2mg for the Acute Treatment of Migraine 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
Source: ClinicalTrials.gov · Last updated 7 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 78 (actual)
- First submitted
- 6 Dec 2024
- Start date
- 24 Feb 2025
- Primary completion date
- 27 Jun 2025
- Lead sponsor
- Manistee Therapeutics
- Diseases
- Migraine
- NCT number
- NCT06728553
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 78
- From 24 Feb 2025 to the primary completion date, 27 Jun 2025
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of more than 2 migraine preventive medications.
- 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.
- 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.
- 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.
Other
- No more than a total of 15 headache days per month.
- Current diagnosis of glaucoma.
Who the study is looking for
- Male or female aged 18 to 65 years at the time of consent.
- Onset of migraine headache before age 50.
- History of episodic migraine headache starting at least 1-year ago with or without aura.
- Has a minimum of 4 monthly migraine days and not more than 10 migraine days per month.
- Able to distinguish pain related to migraine attacks from tension-type and cluster headache attacks.
- Able to understand and provide signed informed consent.
- Willing and able to comply with all scheduled visits, treatment plan, and other study procedures.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| QUEST Research Institute Coordinator of this site? Confirm its status | Farmington Hills | United States | Unknown status |
| Kaizen Brain Center Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Brainstorm Research Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Delricht Research Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Synergy Clinical Research/Emerald Coast Center for Neurological Disorders Coordinator of this site? Confirm its status | Pensacola | United States | Unknown status |
| Wasatch Clinical Research Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Clinical Research Institute, LLC Coordinator of this site? Confirm its status | Santa Monica | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.