A Prospective, Open-Label Study Evaluating the Effectiveness of Gepants for Acute Treatment of Migraine in the Emergency Department
A Prospective, Open-Label Study Evaluating the Effectiveness of Rimegepant ODT or Zavegepant Nasal Spray for Acute Treatment of Migraine in the Emergency Department
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Florida
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Tampa, Florida, United States, 33606
- Tampa General Hospital Emergency Room
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Contact:
- Stella Mensah, RN, BSN
- Phone Number: 813-844-7116
- Email: smensah@tgh.org
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Contact:
- Ashley Bader, RN, BSN
- Email: abader@tgh.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• At least 18 years of age
- Capacity to provide informed consent (without a Representative)
- Emergency Department presentation for a headache consistent with migraine, based either on the treating clinical team's judgement, or fulfillment of International Classification of Headache Disorders (ICHD-3) criteria for migraine without aura or with typical aura, or for probable migraine without aura or with typical aura. It is acceptable if current headache duration is >72 hours. Must have been headache free for >48 hours prior to current attack.
- Willing to participate in post-discharge telephone assessments
- English and/or Spanish speaking patients
Exclusion Criteria:
• Use of intranasal decongestants within 1 hour prior to study drug administration, due to the potential to decrease absorption of intranasal zavegepant.
- Use of analgesics or abortive headache medications within 60 minutes of study medication administration
- Use of the following drug/food categories with potential for drug interactions within 7 days or 5 half-lives, whichever is longer: 1) CYP3A strong or moderate inducers, 2) CYP3A4 strong inhibitors, 3) P-glycoprotein (P-gp) inhibitors, 4) OATP1B3 transporter potent inhibitors/inducers, 5) NTCP transporter potent inhibitors/inducers
- History of ischemic cardiovascular disease, diabetes, or hypertension (diagnosed or likely based on multiple readings), that was recently diagnosed within 3 months of screening or is currently uncontrolled or unstable
- History of any stroke within 3 months, or any lifetime stroke and age ≥65 years
- History of significant peripheral vascular disease, as assessed by the investigator or qualified delegate
- History of Raynaud's Phenomenon (medically diagnosed, or non-medically diagnosed with affirmative responses to both unusual sensitivity and finger color change with cold exposure)
- History of severe hepatic impairment, as assessed by the investigator or qualified delegate
- History of kidney disease stage 4 (eGFR <30 mL/min/1.73 m2)
- History of hypersensitivity reaction to rimegepant, zavegepant, or to any included inactive ingredients
- Lifetime use of CGRP-targeting acute or preventive migraine medications
- In custody of law enforcement
Current pregnancy or lactation
- All individuals of childbearing potential must have a negative pregnancy test at screening (urine or serum).
- A person is considered to be of childbearing potential if possessing female reproductive organs at birth, post-menarchal, has not reached a post-menopausal state (≥12 continuous months of amenorrhea with no cause identified other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Rimegepant (Parallel Trial)
Participants receive a single oral dose of rimegepant 75 mg orally disintegrating tablet during an Emergency Department visit for the acute treatment of migraine. This arm represents one of two independent, parallel pilot trials evaluating the effectiveness and safety of gepant medications in the Emergency Department. This arm is not intended for comparison with the zavegepant arm. |
Rimegepant 75 mg orally disintegrating tablet administered as a single dose during an Emergency Department visit for the acute treatment of migraine.
The tablet is placed on or under the tongue and allowed to dissolve without water, consistent with FDA-approved labeling.
|
|
Experimental: Zavegepant (Parallel Trial)
Participants receive a single dose of zavegepant 10 mg administered as an intranasal spray during an Emergency Department visit for the acute treatment of migraine. This arm represents one of two independent, parallel pilot trials evaluating the effectiveness and safety of gepant medications in the Emergency Department. This arm is not intended for comparison with the rimegepant arm. |
Zavegepant 10 mg nasal spray administered as a single spray into one nostril during an Emergency Department visit for the acute treatment of migraine.
Administration is consistent with FDA-approved labeling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain relief at 2 hours without rescue medication
Time Frame: 2 hours post-study drug administration
|
Evaluate the effectiveness of rimegepant 75 mg ODT or zavegepant 10 mg nasal spray as acute migraine treatments administered during ED encounters • Percentage of participants with pain relief of "mild" or "none" on a 4-point scale (none, mild, moderate, severe) at 2 hours post-study drug administration, without rescue medication |
2 hours post-study drug administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain relief at 2 hours (with or without rescue medication)
Time Frame: 2 hours post-study drug administration
|
Evaluate the effectiveness of rimegepant 75 mg ODT or zavegepant 10 mg nasal spray as acute migraine treatments at 2 hours, with or without rescue medications • Percentage of participants with pain relief achieving "mild" or "none" on a 4-point scale at 2 hours post-study drug administration, analyzed in 2 groups: or 1) achieved pain relief with rimegepant or zavegepant plus rescue medication, or 2) did not achieve pain relief. |
2 hours post-study drug administration
|
|
Early pain relief at 60 minutes
Time Frame: 60 minutes post-study drug administration
|
Evaluate the effectiveness of rimegepant 75 mg ODT or zavegepant 10 mg nasal spray as acute migraine treatments at a timepoint earlier than 2 hours • Percentage of participants with pain relief achieving "mild" or "none" on a 4-point scale at 60 minutes post-study drug administration |
60 minutes post-study drug administration
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY009783
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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