Phase 4 Trial Comparing Vespireit and Arlevert Tablets for Treating Autonomic Dysfunction Syndrome with Functional Vertigo

What this Trial Is About

Researchers are evaluating the effectiveness and safety of Vespireit prolonged-release tablets compared to Arlevert tablets in adults aged 18 to 65 with autonomic dysfunction syndrome accompanied by functional vertigo. This phase 4, open-label, randomized controlled trial investigates how these treatments impact symptoms related to vertigo and autonomic dysfunction. Participants will be randomly assigned to receive either Vespireit, 15 mg once daily in the morning with food, or Arlevert, 40 mg plus 20 mg three times daily with food. Both treatments are taken orally as whole tablets for 28 days. The study includes an initial treatment phase and a retreatment period, with careful monitoring throughout. During the study, participants will have multiple visits to assess changes in vertigo symptoms using the Mean Vertigo Score and Dizziness Handicap Inventory, as well as quality of life and anxiety levels. Researchers will track adverse events and therapy effectiveness through patient and physician evaluations. The study duration includes the initial 28-day treatment with follow-up visits extending through a retreatment period lasting up to 42 days.

Efficacy and Safety of Vespireit, Prolonged-release Tablets, in Patients With Autonomic Dysfunction Syndrome Accompanied by Functional Vertigo