NCT06321341

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

Open-label, Multicenter, Randomized Controlled Phase 4 Trial Evaluating the Efficacy and Safety of Vespireit, Prolonged-release Tablets (Valenta Pharm JSC, Russia) Versus Arlevert, Tablets (Menarini International Operations Luxembourg S.A., Luxembourg) in Patients With Autonomic Dysfunction Syndrome Accompanied by Functional Vertigo.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Valenta Pharm JSC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy and safety of Vespireit, prolonged-release tablets, 15 mg (Valenta Pharm JSC, Russia) in comparison with Arlevert, tablets, 40 mg + 20 mg (Menarini International Operations Luxembourg S.A., Luxembourg) in patients with autonomic dysfunction syndrome accompanied by functional vertigo.

Conditions

• Vertigo
• Autonomic Dysfunction

Interventions

Type	Name	Description
DRUG	Vespireit	Buspirone
DRUG	Arlevert	Dimenhydrinate + Cinnarizine

Timeline

• Start date: 2024-01-24
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-03-20
• Last updated: 2025-06-15

Locations

4 sites across 1 country: Russia