Rimegepant for the Prevention of Episodic Migraine in Adults with Prior Inadequate Response to Oral Preventatives: Results from a 12-week Open-label Extension Phase of a Randomized, Placebo-controlled Trial
Patricia Pozo-Rosich1, Jose Gien-Lopez2, Pawel Lisewski3, Ayşe Neslihan Aslan4, Harpreet Seehra5, Alexandra Thiry4, Lucy Abraham5, Luz Ramirez4, Robert Fountaine4, Terence Fullerton4
1Headache Unit, Neurology Department, Vall d'Hebron University Hospital, 2Star Medica Hospital, 3Tricals, 4Pfizer Inc., 5Pfizer R&D UK Ltd.
Objective:
Report findings from the open-label extension (OLE) phase of a multinational, randomized, placebo-controlled trial evaluating rimegepant for the prevention of episodic migraine in participants with a history of inadequate response to oral preventive medications (OPMs).
Background:
Many patients have found inadequate benefit from prior OPMs due to lack of efficacy, intolerance, or contraindication.
Design/Methods:
Participants with 4–14 monthly migraine days, <15 monthly headache days (<7 non-migraine), and documented history of inadequate response to 2–4 categories of OPM were enrolled. Following 12 weeks of randomized double-blind treatment (DBT) with rimegepant 75 mg orally disintegrating tablet (ODT) or placebo once every other day (EOD), participants entered an OLE phase to receive 12 weeks of rimegepant 75 mg EOD. Other preventive medications were not permitted.
Results:
At entry to the OLE phase, demographics and clinical characteristics were balanced across the 301 participants who previously received rimegepant and the 294 who received placebo as DBT. During the OLE phase, a mean of 14 ODTs were taken/month in both DBT groups. After 12 weeks of open-label (OL) rimegepant (Week 24 of the trial), change from baseline in patient-reported outcomes showed participants who received placebo as DBT achieved similar benefit as those on rimegepant since the start of the trial. During the OLE phase, 38.2% of participants had ≥1 adverse event (AE), including 6.6% related to rimegepant and 1.0% leading to rimegepant discontinuation. The three most common AEs were nasopharyngitis, influenza, and upper respiratory tract infection; the majority of AEs were mild or moderate in intensity. The safety profile of OL rimegepant was comparable across DBT groups and with previous trial findings.
Conclusions:
Rimegepant is well tolerated and reduces overall disease burden when taken for the prevention of migraine in participants with a documented history of prior inadequate response to OPMs. NCT05518123
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