A Prospective, Open-Label Study Evaluating the Effectiveness of Gepants for Acute Treatment of Migraine in the Emergency Department

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT07667621
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Rimegepant — DRUG
    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.
  • Zavegepant — DRUG
    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

Study Details

Prospective, single-site, open-label, non-controlled pilot study consisting of two parallel trials. Participants will receive rimegepant or zavegepant for acute migraine treatment during a single Emergency Department visit, with post-discharge follow-up through 28 days. Participants will be allocated to either the rimegepant trial or the zavegepant trial. The study design does not include a placebo or active comparator control group, and the two gepant study drugs are not designed to function as active comparator groups. The objective in this investigation is to examine relief from either rimegepant or zavegepant in separate parallel trials.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Pain relief at 2 hours without rescue medication [ Time Frame: 2 hours post-study drug administration ]

Locations (1)

FacilityCityStateZIPSite coordinators
Tampa General Hospital Emergency RoomTampaFlorida33606
Stella Mensah, RN, BSN
[email protected]
813-844-7116
Ashley Bader, RN, BSN
[email protected]

Find similar trials in Tampa, FL

By condition
Migraine
By specialty
Neurology
By research site
Tampa General Hospital Emergency Room· Tampa, FL

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