MigrainePhase 2NCT06728553
Safety and Efficacy Trial of MTX101 2mg for the Acute Treatment of Migraine in Adults
A Phase 2 study testing MTX101 in people with Migraine, run by Manistee Therapeutics at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- MTX101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 7 sitesUnited States
- Study dates
- 24 Feb 2025to 28 Jul 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- No more than a total of 15 headache days per month.
- Use of more than 2 migraine preventive medications.
- Current diagnosis of glaucoma.
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
QUEST Research Institute
Farmington Hills, Michigan, 48334
Kaizen Brain Center
La Jolla, California, 92037
Brainstorm Research
Miami, Florida, 33176
DelRicht Research
New Orleans, Louisiana, 70115
Synergy Clinical Research/Emerald Coast Center for Neurological Disorders
Pensacola, Florida, 32504
Wasatch Clinical Research
Salt Lake City, Utah, 84107
Clinical Research Institute, LLC
Santa Monica, California, 90048
About this study
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
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.
Read more
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.
Read the detailed description
Subjects enrolled in the study will be randomized to receive investigational product (MTX101 2mg or placebo), to be taken as soon as they have a migraine headache that reaches moderate to severe intensity. Subjects will take a single dose of either active or placebo to treat one migraine headache. Rescue medication should not be taken until at least 2 hours post study medication dose.
The subject will have a telephone check up within 72 to 120 hours after treatment of the first migraine headache.
The subject will treat a 2nd moderate to severe migraine at least 48 hours after the first treated migraine headache.
The subject will return to the clinic for re-evaluation within a 4 week period from the start of the study.
- Conditions
- Migraine
- Being tested
- MTX101, Placebo
- Keywords
- acute treatment of migraine, nervous system diseases, central nervous system diseases, brain diseases, headache, migraine with or without aura
- Medical subject headings
- Migraine Disorders, Nervous System Diseases, Central Nervous System Diseases, Brain Diseases, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTX101Drug
One 2 mg sublingual tablet of MTX101
PlaceboDrug
One sublingual tablet of placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
| Active | Experimental | 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. Receives: Drug: MTX101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment (occurrence of adverse events, treatment emergent adverse events and serious adverse events).
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.
Measured: Treatment emergent adverse event safety assessments will be limited to the first 48 hours after a treated attack.
Secondary outcomes (1)
The change in migraine headache pain score, using an 11-point Numerical Rating Scale, (0=no pain, 10=worst possible pain).
This objective will be measured by change in migraine headache pain score, using an 11-point Numerical Rating Scale, (0=no pain, 10=worst possible pain), from the time of dosing (t=0 hour) to 2 hours post-dose as recorded on the subject's Diary.
Measured: From the time of dosing (t=0 hour) to 2 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start24 Feb 2025
- Primary completion27 Jun 2025
- Study completion28 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manistee Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728553
- Sponsor's protocol ID
- MTX101-0202 / Pro00082158
- Status last verified
- Oct 2025
- First submitted
- 6 Dec 2024
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06728553
- Acronym / sponsor ID
- MTX101-0202 / Pro00082158
- Conditions
- Migraine
- Keywords
- acute treatment of migraine, nervous system diseases, central nervous system diseases, brain diseases, headache, migraine with or without aura
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Manistee TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 28 Jul 2025 (actual)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subjects enrolled in the study will be randomized to receive investigational product (MTX101 2mg or placebo), to be taken as soon as they have a migraine headache that reaches moderate to severe intensity. Subjects will take a single dose of either active or placebo to treat one migraine headache. Rescue medication should not be taken until at least 2 hours post study medication dose.
The subject will have a telephone check up within 72 to 120 hours after treatment of the first migraine headache.
The subject will treat a 2nd moderate to severe migraine at least 48 hours after the first treated migraine headache.
The subject will return to the clinic for re-evaluation within a 4 week period from the start of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSubjects 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. |
| Active | Experimental | Drug: MTX101Subjects 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- No more than a total of 15 headache days per month.
- Use of more than 2 migraine preventive medications.
- Current diagnosis of glaucoma.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTX101One 2 mg sublingual tablet of MTX101 | Drug | Active |
| PlaceboOne sublingual tablet of placebo | Drug | Placebo |
Primary outcome
Safety assessment (occurrence of adverse events, treatment emergent adverse events and serious adverse events).
Time frame: Treatment emergent adverse event safety assessments will be limited to the first 48 hours after a treated attack.
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.
1 secondary outcome
The change in migraine headache pain score, using an 11-point Numerical Rating Scale, (0=no pain, 10=worst possible pain).
Time frame: From the time of dosing (t=0 hour) to 2 hours post-dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Medical Officer study director
Sponsor GmbH
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MTX101 in people with Migraine, run by Manistee Therapeutics at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessment (occurrence of adverse events, treatment emergent adverse events and serious adverse events). (time frame: Treatment emergent adverse event safety assessments will be limited to the first 48 hours after a treated attack.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.