Efficacy and Safety of Rimegepant for Acute Dizziness

Sponsor
Shi Tianming
Study ID
NCT07435090
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Dizziness

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Rimegepant 75mg Orally Disintegrating Tablets (ODT) — DRUG
    A single dose of Rimegepant orally disintegrating tablets (75 mg) combined with betahistine mesylate (12 mg) administered orally.
  • Betahistine Mesylate tablet — DRUG
    A single dose of betahistine mesylate (12 mg) administered orally.

Study Details

This study aims to explore the efficacy and safety of rimegepant for acute dizziness, including vestibular migraine (VM) and benign recurrent vertigo (BRV), through a multicenter, randomized controlled clinical trial. This study addresses the urgent clinical need for effective therapies for acute dizziness. Additionally, we will dynamically observe the changes in calcitonin gene-related peptide (CGRP) levels before and after treatment and explore the predictive value of CGRP levels for treatment efficacy and the prognosis of recurrence in patients. This study aims to provide a scientific basis to improve clinical management strategies for acute dizziness.

Key Dates

Start date
Mar 20, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
370 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rimegepant group
  • Active Comparator: Control group

Primary Outcome Measure

The proportion of patients whose dizziness symptoms decreased from moderate or severe to none or mild after 1 hour of administration. [ Time Frame: 1 hour after drug administration. ]

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