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NCT06728553 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy Trial of MTX101 2mg for the Acute Treatment of Migraine in Adults
A Phase 2 study of Migraine, sponsored by Manistee Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
- 7
- Study locations
NCT06728553: Completed Phase 2 study of Migraine, sponsored by Manistee Therapeutics.
NCT06728553 is a Phase 2 study of Migraine that has completed, run by Manistee Therapeutics. The registered enrollment target is 78 participants, below the 357-participant average among 102 other Migraine trials with a reported enrollment target (78% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06728553, a Phase 2 study of Migraine, has completed, sponsored by Manistee Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
- 7
- Study locations
Study Summary
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.
Primary Outcome
To assess the tolerability and safety of MTX101. This objective will be measured by assessing the number of unique subjects with deaths, serious adverse events, and moderate and severe adverse events.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG MTX101
Study Locations (7)
California
- Kaizen Brain Center - La Jolla
- Clinical Research Institute, LLC - Santa Monica
Florida
- Brainstorm Research - Miami
- Synergy Clinical Research/Emerald Coast Center for Neurological Disorders - Pensacola
Louisiana
- DelRicht Research - New Orleans
Michigan
- QUEST Research Institute - Farmington Hills
Utah
- Wasatch Clinical Research - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2025-02-24 |
| Est. Completion | 2025-07-28 |
| Phase | Phase 2 |
What the finished NCT06728553 record still lists
NCT06728553 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 357-participant average among 102 other Migraine trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Migraine appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06728553 lists 7 locations in 5 states (California, Florida, Louisiana).
Frequently Asked Questions
What is clinical trial NCT06728553 about?
NCT06728553 is a clinical study titled "Safety and Efficacy Trial of MTX101 2mg for the Acute Treatment of Migraine in Adults". 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 medica...
What is the current status of trial NCT06728553?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2025-02-24. Estimated completion is 2025-07-28.
What conditions does trial NCT06728553 study?
This clinical trial studies the following conditions: Migraine.
What interventions are being tested in trial NCT06728553?
The interventions under investigation include: Placebo (DRUG), MTX101 (DRUG).
Who is sponsoring clinical trial NCT06728553?
This trial is sponsored by Manistee Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06728553 being conducted?
This trial has 7 study locations across California, Florida, Louisiana, Michigan, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Migraine
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06728553's enrollment target sits among peer trials
78 67th of 102 higher than 36 of 102 other Migraine trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Migraine trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Migraine Manager (R01)
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Bilateral Middle Meningeal Artery Lidocaine Infusion for Chronic Debilitating Migraines
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A Study to Investigate the Safety and Efficacy of MEDI0618 Compared to Placebo in Adult Participants With Episodic Migraine
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A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments
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-
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COMPLETED · Phase 2
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