Safety and Efficacy Trial of MTX101 2mg for the Acute Treatment of Migraine in Adults
Public ClinicalTrials.gov record NCT06728553. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06728553
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 78 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 24, 2025 (Actual)
- Primary completion
- Jun 27, 2025 (Actual)
- Completion
- Jul 28, 2025 (Actual)
- Last update posted
- Oct 7, 2025
2025
United States locations
- U.S. sites
- 7
- U.S. states
- 5
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kaizen Brain Center | La Jolla | California | 92037 | — |
| Clinical Research Institute, LLC | Santa Monica | California | 90048 | — |
| Brainstorm Research | Miami | Florida | 33176 | — |
| Synergy Clinical Research/Emerald Coast Center for Neurological Disorders | Pensacola | Florida | 32504 | — |
| DelRicht Research | New Orleans | Louisiana | 70115 | — |
| QUEST Research Institute | Farmington Hills | Michigan | 48334 | — |
| Wasatch Clinical Research | Salt Lake City | Utah | 84107 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06728553, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 7, 2025 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06728553 live on ClinicalTrials.gov.