MigrainePhase 4RIMNCT07301008
Rimegepant as Preemptive Treatment for Predictable Trigger-Induced Migraine in Adult Patients in the US
A Phase 4 study testing Rimegepant 75 MG in people with Migraine and Trigger Induced Migraine, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
Single-center, open label, prospective study conducted at Medstar Georgetown Headache Center. Men and woman ≥ 18 years old that are diagnosed with migraine with or without aura for at least 1 year, who report a reliable migraine trigger. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, Trigger Induced Migraine
- What is being tested?
- Rimegepant 75 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2025to Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Patients with at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders-3 (ICHD-3)
- Men and women ≥ 18 years old .
- Average of 2-8 migraine attacks of moderate or severe intensity per month within the last 3 months prior to the screening visit
- Headache/migraine onset before age 50 years
- Migraine attacks, on average, lasting 4-72 hours if untreated
- At least 48 hours between migraine attacks
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- Ability to distinguish migraine attacks from tension or cluster headaches
- Particpants on SOC treatment should be on stable regimen for at least 3 months prior to enrollment and should not change their regimen during the course of the study
- Participant may have been on treatment with Botox or mAbs for the last 6 months
- Participants experience migraine ≥75% of the time following exposure to a trigger during the run-in period. Acceptable triggers include exercise, alcohol ( less than one drink per day for woman and less than two drinks per day for men), air travel that lasts no more than 12 hours, sexual activity, fasting that lasts no more than 24 hours, stress or weekend/ let-down
Who cannot join
- Using gepants as preventive treatment (atogepant once daily (QD) or rimegepant every other day (EOD)), or using zavegepant or ubrogepant as an acute treatment
- History of use of narcotic or barbiturate containing medications, including opioids (e.g., morphine, codeine, oxycodone, and hydrocodone) on ≥5 days per month on a regular basis for ≥3 months prior to screening
- Current evidence of uncontrolled, unstable, or recently diagnosed cardiovascular disease, uncontrolled hypertension, or uncontrolled diabetes.
- Current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder.
- Women must not be pregnant, lactating or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MedStar Health: Neurology at McLean
McLean, Virginia, 22101
Yemisrach Tadesse, 3015708508, yemisrach.g.tadesse@medstar.net
Jessica Ailani, MD
About this study
Single-center, open label, prospective study conducted at Medstar Georgetown Headache Center. Men and woman ≥ 18 years old that are diagnosed with migraine with or without aura for at least 1 year, who report a reliable migraine trigger. Acceptable triggers for the study will include exercise, alcohol (less than one drink per day for woman and less than two drinks per day for men), air travel that lasts no more than 12 hours, sexual activity, fasting that lasts no more than 24 hours, stress or stress let-down headache.
- Conditions
- Migraine, Trigger Induced Migraine
- Being tested
- Rimegepant 75 MG
- Keywords
- Trigger- induced migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rimegepant 75 MGDrug
The interventional product is rimegepant ODT 75 mg. Rimegepant 75mg ODT will be given 2 hours prior to a trigger exposure for exercise, alcohol (less than one drink per day for woman and less than two drinks per day for men), air travel that lasts no more than 12 hours, sexual activity, fasting that lasts no more than 24 hours rimegepant will be dosed 2 hours prior to trigger exposure. For weekend or let down headache and changes in sleep pattern, rimegepant will be dosed the night before. The maximum dose in a 24-hour period is 75mg.
| Study group | Role | What they receive |
|---|---|---|
| Rimegepant 75 MG | Experimental | Not described Receives: Drug: Rimegepant 75 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of preemptive treatments with rimegepant in which migraine with a moderate to severe headache intensity
Percentage of preemptive treatments with rimegepant in which migraine with a moderate to severe headache intensity occurs within 24 hours
Measured: 24 hour post dose
Secondary outcomes (3)
Percentage of preemptive treatments with rimegepant
Percentage of preemptive treatments with rimegepant in which migraine occurs within 24 hours
- Percentage of preemptive treatments with rimegepant that require rescue medication within 24 hours
- Percentage of preemptive treatments with rimegepant that result in acute medication use within 48 hours of treatment
Measured: 24 hour, 48 hour post dose
Patient satisfaction with preemptive treatment with rimegepant
Patient satisfaction with preemptive rimegepant treatment will be assessed in the case report form using a Likert scale
Measured: At the end of the study completion( 2 month after enrollment)
The effect of preemptive treatment with rimegepant on Patient Global Impression of Change (PGIC)
The effect of preemptive treatment with rimegepant on Patient Global Impression of Change (PGIC) using a graded scale of 1-7.
Measured: At the end of study completion( 2 months after enrollement)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start9 Sep 2025
- Primary completionSep 2026 (estimated)
- Study completionJan 2027 (estimated)
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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Jessica Ailani, MD, Principal investigator, MedStar's Georgetown University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301008
- Sponsor's protocol ID
- STUDY00008797
- Acronym
- RIM
- Status last verified
- Dec 2025
- First submitted
- 20 Oct 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rimegepant as Preemptive Treatment for Predictable Trigger-Induced Migraine in Adult Patients in the US
- ClinicalTrials.gov ID
- NCT07301008
- Acronym / sponsor ID
- RIM / STUDY00008797
- Conditions
- Migraine, Trigger Induced Migraine
- Keywords
- Trigger- induced migraine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 24 Dec 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.
Single-center, open label, prospective study conducted at Medstar Georgetown Headache Center. Men and woman ≥ 18 years old that are diagnosed with migraine with or without aura for at least 1 year, who report a reliable migraine trigger. Acceptable triggers for the study will include exercise, alcohol (less than one drink per day for woman and less than two drinks per day for men), air travel that lasts no more than 12 hours, sexual activity, fasting that lasts no more than 24 hours, stress or stress let-down headache.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rimegepant 75 MG | Experimental | Drug: Rimegepant 75 MG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders-3 (ICHD-3)
- Men and women ≥ 18 years old .
- Average of 2-8 migraine attacks of moderate or severe intensity per month within the last 3 months prior to the screening visit
- Headache/migraine onset before age 50 years
- Migraine attacks, on average, lasting 4-72 hours if untreated
Key exclusion criteria (5 listed)
- Using gepants as preventive treatment (atogepant once daily (QD) or rimegepant every other day (EOD)), or using zavegepant or ubrogepant as an acute treatment
- History of use of narcotic or barbiturate containing medications, including opioids (e.g., morphine, codeine, oxycodone, and hydrocodone) on ≥5 days per month on a regular basis for ≥3 months prior to screening
- Current evidence of uncontrolled, unstable, or recently diagnosed cardiovascular disease, uncontrolled hypertension, or uncontrolled diabetes.
- Current diagnosis of major depressive disorder requiring treatment with atypical antipsychotics, schizophrenia, bipolar disorder, or borderline personality disorder.
- Women must not be pregnant, lactating or breastfeeding
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 |
|---|---|---|
| Rimegepant 75 MGThe interventional product is rimegepant ODT 75 mg. Rimegepant 75mg ODT will be given 2 hours prior to a trigger exposure for exercise, alcohol (less than one drink per day for woman and less than two drinks per day for men), air travel that lasts no more than 12 hours, sexual activity, fasting that lasts no more than 24 hours rimegepant will be dosed 2 hours prior to trigger exposure. For weekend or let down headache and changes in sleep pattern, rimegepant will be dosed the night before. The maximum dose in a 24-hour period is 75mg. | Drug | Rimegepant 75 MG |
Primary outcome
Percentage of preemptive treatments with rimegepant in which migraine with a moderate to severe headache intensity
Time frame: 24 hour post dose
Percentage of preemptive treatments with rimegepant in which migraine with a moderate to severe headache intensity occurs within 24 hours
3 secondary outcomes
Percentage of preemptive treatments with rimegepant
Time frame: 24 hour, 48 hour post dose
Patient satisfaction with preemptive treatment with rimegepant
Time frame: At the end of the study completion( 2 month after enrollment)
The effect of preemptive treatment with rimegepant on Patient Global Impression of Change (PGIC)
Time frame: At the end of study completion( 2 months after enrollement)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- 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.
Jessica Ailani, MD principal investigator
MedStar's Georgetown University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rimegepant 75 MG in people with Migraine and Trigger Induced Migraine, run by Medstar Health Research Institute at 1 site 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 10 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yemisrach Tadesse (3015708508, yemisrach.g.tadesse@medstar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of preemptive treatments with rimegepant in which migraine with a moderate to severe headache intensity (time frame: 24 hour post dose). 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 24 Dec 2025.