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Purpose

Acute treatments for migraine may not provide sufficient pain relief after an initial dose, and a second dose of a given medication may be needed to fully abort an attack. International Headache Society (IHS) global practice recommendations for the Acute Treatment of Migraine suggest a second dose of the same medication within the recommended dose limit in people with headache relapse after successful initial treatment of a migraine attack. The primary purpose of this study is to evaluate the safety and tolerability of redosing of rimegepant when taken for the acute treatment of a migraine attack, as it is possible that some patients may benefit from a second dose of rimegepant in this setting.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Criteria

Inclusion:

- Eligible participants include adult participants aged 18 years of age or older with
a minimum 1-year history of migraine (with or without aura) consistent with
International Classification of Headache Disorders, 3rd Edition

- Eligible participants must be currently using acute migraine treatment in accordance
with the local label and have all of the following on average across the 12 weeks
prior to the Screening Visit and, during the first 28 days of the observation phase
(OP): (1) 6-14 monthly migraine days (MMDs); (2) <15 monthly headache days (MHDs)
(migraine or non-migraine); and (3) <7 monthly non-migraine headache days.

Exclusion:

- Participants with headaches occurring ≥15 days per month (migraine or non-migraine)
on average across the 12 weeks prior to the Screening Visit and ≥7 non-migraine
headache days per month on average across the 12 weeks prior to the Screening Visit
would not be eligible.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Rimegepant 		Participants will receive rimegepant 75 mg ODT to administer for the acute treatment of migraine attacks of moderate or severe headache pain intensity. A second rimegepant 75 mg ODT should be taken in the event that participants are not pain free at approximately 2 hours post initial dose OR upon headache relapse after initial pain freedom. The second dose should be taken within 24 hours of the initial dose. Participants will receive rimegepant over a 24 week period during the OLT phase. Participants may redose with rimegepant up to a maximum of 10 times per month (28 days) during the OLT phase.
  • Drug: Rimegepant
    Rimegepant

Recruiting Locations

Neurology Offices of South Florida
Boca Raton, Florida 33428

More Details

Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Detailed Description

To evaluate the safety and tolerability of rimegepant 75 mg ODT when redosed due to residual pain or headache relapse

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.