Efficacy and Safety of Rimegepant for Acute Dizziness

Официальное название

A Multicenter Randomized Controlled Trial on the Efficacy and Safety of Rimegepant in the Treatment of Acute Dizziness

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

• Age between 18 and 65 years;
• Spontaneous dizziness without cochlear symptoms, with moderate or severe symptom intensity. The severity of dizziness is assessed based on the Vertigo or Dizziness Visual Analog Scale (VAS) score, and this study included patients with dizziness exceeding 4 points on the VAS score;
• The patient has experienced at least 3 similar dizziness attacks in the past, with each attack lasting more than 2 hours;
• The accompanying symptoms or related medical history during the attack period meet any of the following criteria: 1) Migraine-like headache (unilateral, pulsatile, moderate to severe, aggravated by activity; at least 2 items); 2) Photophobia and phonophobia; 3) Nausea or vomiting; 4) Visual aura; 5) Nystagmus; 6) The patient has a personal history of migraine; 7) Severe kinetosis; 8) Family history of migraine; 9) Typical triggering factors for migraine (menstrual period, alcohol consumption, sleep disturbances);
• The patient has completed emergency laboratory examination and imaging evaluation to preliminarily rule out dizziness attacks caused by other reasons;
• The patient can sign an informed consent form.

Критерии исключения

• New focal neurological signs;
• History of previous stroke or transient ischemic attack;
• ABCD2 score ≥ 4 points;
• Presence of other vestibular peripheral vertigo disorders, such as benign paroxysmal positional vertigo, Meniere's disease, vestibular neuritis, sudden deafness, etc.;
• Unexplained hearing abnormalities;
• History of serious internal medical or mental illnesses, such as coronary heart disease (acute coronary syndrome), severe heart failure (New York Heart Association Functional Classification class II or above), severe arrhythmia (such as severe bradycardia, third-degree atrioventricular block, ventricular tachycardia, etc.), severe liver dysfunction (alanine aminotransferase or aspartate aminotransferase exceeding three times the upper limit of normal), severe renal dysfunction (serum creatinine level exceeding twice the upper limit of normal), uncontrolled severe hypertension (blood pressure above 180/120 mmHg), active malignant tumors, and uncontrolled mental illness;
• Pregnant or breastfeeding women;
• Self-administered vestibular inhibitors or CGRP drugs after the dizziness attack;
• History of intolerance or allergy to rimegepant use;
• Anticipated inability to comply with research requirements.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07435090 · RECOVER

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗