Rimegepant as Preemptive Treatment for Predictable Trigger-Induced Migraine in Adult Patients in the US
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedstar Health Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Rimegepant 75 MG
DrugThe 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Rimegepant 75 MGExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
24 hour post doseSecondary outcomes
1
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
Time frame
24 hour, 48 hour post dose2
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
Time frame
At the end of the study completion( 2 month after enrollment)3
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.
Time frame
At the end of study completion( 2 months after enrollement)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Medstar Health Research Institute
Lead sponsor
Pfizer
Collaborator
Source ClinicalTrials.gov