Chronic Migraine HeadacheNCT06862674
Clinical Exploration of NEUROMARK System in Participants With Chronic Migraine
A study testing NEUROMARK System in people with Chronic Migraine Headache, run by Neurent Medical at 7 sites in United States.
Trial summary
Clinical exploration of NEUROMARK System in Participants with Chronic Migraine Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Migraine Headache
- What is being tested?
- NEUROMARK System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 7 sitesUnited States
- Study dates
- 6 Sep 2024to 21 Jan 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant Must:
- Be ≥18 years of age.
- Have Chronic Migraine
- Be willing and able to comply with all study elements, as indicated by written informed consent.
Who cannot join
- Participant Must Not:
- Have diagnosis or history of complicated migraine, basilar migraine, ophthalmoplegic migraine, hemiplegic migraine, or migrainous infarction.
- Progressive neurologic disorder other than migraine.
- Have clinically significant anatomic obstruction that in the investigator's opinion limit access to the posterior nose, including but not limited to severe septal deviation or perforation, nasal polyps, and/or sinonasal tumor.
- Have plans to (or otherwise anticipates the need to) undergo an ENT procedure concurrently or during study.
- Have had previous sinus or nasal surgery within 6 months of study enrollment.
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- Have previously undergone radiofrequency, cryotherapy, or other surgical interventions for rhinitis.
- Have started a new migraine medication regimen within 3 months of study enrollment that, according to the manufacturer's labeling, has not yet stabilized.
- Have an acute nasal or sinus infection.
- Have nasal mucosal erosion/ulceration.
- Be on prescribed anticoagulants (eg, warfarin, Plavix) or 325 mg aspirin that cannot be held for an appropriate time before the procedure.
- Have hemophilia.
- Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.
- Have numbness of the soft palate, excessive dry eye, excessive dry nose, or other indication of neuro/nerve compromise in the sinonasal cavity.
- Have had previous head and/or neck irradiation.
- Be pregnant.
- Have a physical, neurological, medical, psychiatric condition or situation that, in the investigator's opinion, puts the participant at risk, could confound the study results, or may interfere significantly with the participant's participation in the study.
- Be participating in another clinical research study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Ascension St. Vincent
Anderson, Indiana, 46016
Specialty Physician Associates
Bethlehem, Pennsylvania, 18017
ExcelENT
Birmingham, Alabama, 36801
Sensa Health
Los Angeles, California, 90006
East Alabama ENT
Opelika, Alabama, 36801
Sacramento ENT
Sacramento, California, 95661
Senta Clinic
San Diego, California, 92108
About this study
Clinical exploration of NEUROMARK System in Participants with Chronic Migraine
- Conditions
- Chronic Migraine Headache
- Being tested
- NEUROMARK System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEUROMARK SystemDevice
NEUROMARK System for Chronic Migraine
| Study group | Role | What they receive |
|---|---|---|
| Single-arm Treatment | Experimental | Participants that provide informed consent and meet study eligibility requirements will receive treatment. Participants will have the NEUROMARK System applied to both nostrils during a single session. Receives: Device: NEUROMARK System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from Baseline in Monthly Migraine Headache Days
Monthly headache logs were used to record headache frequency, intensity, duration, and pain. Mean change from baseline in number of migraine headache days per month was assessed over 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start6 Sep 2024
- Primary completion21 Jan 2026
- Study completion21 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Migraine HeadacheStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurent Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862674
- Sponsor's protocol ID
- CIP-0011
- Status last verified
- Sep 2026
- First submitted
- 23 Jan 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Exploration of NEUROMARK System in Participants With Chronic Migraine
- ClinicalTrials.gov ID
- NCT06862674
- Acronym / sponsor ID
- CIP-0011
- Conditions
- Chronic Migraine Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Neurent MedicalIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2024 (actual)
- Primary completion
- 21 Jan 2026 (actual)
- Study completion
- 21 Jan 2026 (actual)
- First posted
- 6 Mar 2025 (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.
Clinical exploration of NEUROMARK System in Participants with Chronic Migraine
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm Treatment | Experimental | Device: NEUROMARK SystemParticipants that provide informed consent and meet study eligibility requirements will receive treatment. Participants will have the NEUROMARK System applied to both nostrils during a single session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be ≥18 years of age.
- Have Chronic Migraine
- Be willing and able to comply with all study elements, as indicated by written informed consent.
Key exclusion criteria (18 listed)
- Have diagnosis or history of complicated migraine, basilar migraine, ophthalmoplegic migraine, hemiplegic migraine, or migrainous infarction.
- Progressive neurologic disorder other than migraine.
- Have clinically significant anatomic obstruction that in the investigator's opinion limit access to the posterior nose, including but not limited to severe septal deviation or perforation, nasal polyps, and/or sinonasal tumor.
- Have plans to (or otherwise anticipates the need to) undergo an ENT procedure concurrently or during study.
- Have had previous sinus or nasal surgery within 6 months of study enrollment.
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 |
|---|---|---|
| NEUROMARK SystemNEUROMARK System for Chronic Migraine | Device | Single-arm Treatment |
Primary outcome
Mean Change from Baseline in Monthly Migraine Headache Days
Time frame: 6 months
Monthly headache logs were used to record headache frequency, intensity, duration, and pain. Mean change from baseline in number of migraine headache days per month was assessed over 6 months.
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 16 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEUROMARK System in people with Chronic Migraine Headache, run by Neurent Medical 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 4 inclusion and 18 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 16 Sep 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Mean Change from Baseline in Monthly Migraine Headache Days (time frame: 6 months). 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 16 Sep 2026.