Migraine study: Rimegepant
Official title Rimegepant as Preemptive Treatment for Predictable Trigger-Induced Migraine in Adult Patients in the US
ClinicalTrials.gov ID: NCT07301008
What this study is testing
What is Rimegepant 75 mg ODT?
an investigational oral tablet being studied as a potential treatment to prevent migraine attacks triggered by specific activities or conditions. is designed to block the CGRP receptor, which is involved in migraine pathways.
Also referred to as Nurtec ODT.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if taking rimegepant before a predictable trigger can prevent a migraine attack.
- Who it's for
- Adults 18 or older who have migraine for at least one year and can identify a reliable trigger such as exercise, alcohol, travel, or stress.
- What's involved
- Participants will take rimegepant before their trigger and then report on migraine symptoms. They will visit the Medstar Georgetown Headache Center for study visits and may have tests or questionnaires.
- Time commitment
- The study lasts until the participant has used rimegepant for several trigger events, with visits scheduled at the headache center as needed.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with at least 1 year history of episodic migraine (with or without aura) consistent with a diagnosis according to the International...
- 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
You likely can't join if
- Using gepants as preventive treatment (atogepant once daily (QD) or rimegepant every other day (EOD)), or using zavegepant or ubrogepant as an acute...
- History of use of narcotic or barbiturate containing medications, including opioids (e.g., morphine, codeine, oxycodone, and hydrocodone) on ≥5 days...
- 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...
- Women must not be pregnant, lactating or breastfeeding
See the full eligibility criteria
- 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
- 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.
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- McLean, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at McLean, Virginia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.