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

NCT06321341 | Recruiting Phase 4

• 1 other identifier: BUSP-04-04-2023
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Mean vertigo score (MVS) at Visit 1-3 of the Initial Treatment Phase relative to baseline at Visit 1-1

  Difference in MVS assessed on Visit 1-3 and 1-1 (12-item scale with score from 0 to 4 for each item; higher scores mean a worse outcome)

  Day 1 - Day 28±1

Secondary Outcomes (31)

• Change in mean MVS score at Visit 1-2 of the Initial Treatment Phase relative to baseline at Visit 1-1.

  Day 1 - Day 28±1

• Change in mean MVS score at Visits 2-2, 2-3, and 2-4 of the Retreatment Period compared with Visit 2-1.

  Day 1 - Day 42 ±1 (retreatment period)

• Change in mean MVS score at the visit of completion of study participation compared with the score at Visit 1-1 in patients who completed the study according to the protocol (PP(response)).

  Day 1 - Day 28±1

• Percentage of patients with a ≥50% reduction in total DHI score on Visit 1-3 of the Initial Treatment Phase relative to Visit 1-1.

  Day 1 - Day 28±1

• Percentage of patients with a ≥50% reduction in total DHI score on Visits 2-3 and 2-4 of the Retreatment Period relative to Visit 2-1.

  Day 1 - Day 42 ±1 (retreatment period)

Study Arms (2)

Vespireit, prolonged-release tablets, 15 mg

EXPERIMENTAL

Dosage regimen: 1 tablet once a day at approximately the same time in the morning under fed conditions for 28 days. The drug is taken orally, whole, without breaking and not chewing.

Drug: Vespireit

Arlevert, tablets, 40 mg + 20 mg

ACTIVE COMPARATOR

Dosage regimen: 1 tablet 3 times a day at approximately the same time under fed conditions for 28 days. The drug is taken orally, whole, without breaking and not chewing.

Drug: Arlevert

Interventions

Vespireit DRUG

Buspirone

Vespireit, prolonged-release tablets, 15 mg

Arlevert DRUG

Dimenhydrinate + Cinnarizine

Arlevert, tablets, 40 mg + 20 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient signed and dated the Informed Consent Form.
• Males and females ≥18 to ≤ 65 years of age inclusive at the time of signing the Informed Consent Form.
• Clinical diagnosis: G90.8 Other disorders of autonomic nervous system or G90.9 Disorder of autonomic nervous system, unspecified.
• Diagnosed chronic functional vertigo per Barani Society criteria: total DHI score ≥ 31 points; mean MVS score ≥ 1.5 points.
• For women of childbearing potential, a negative pregnancy test and consent to use an authorized method of contraception throughout the entire period of study participation, starting from Visit 0, and for 3 weeks after the end of the study; for men, consent to use an authorized method of contraception throughout the entire period of study participation and for 3 weeks after the end of the study.
• The authorized contraceptive methods in this study are: intrauterine device, barrier method, or dual barrier method (condom or occlusive cap (diaphragm or cervical/vaginal cap) plus spermicide)). Hormonal contraception was not permitted due to insufficient data on drug interactions of buspirone.
• Postmenopausal women (≥2 years of amenorrhea) or women who are surgically sterile (hysterectomy, bilateral ovariectomy, tubal ligation)) and men with documented infertility or vasectomy will also be eligible for the study.
• Known or suspected hypersensitivity to the active substance or any of the excipients of the investigational drugs.
• Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
• A cumulative score \> 2 on the Suicide Risk Assessment Scale (SRAS).
• Chronic heart failure III-IV functional classes according to the New York Heart Association (NYHA) classification, angina pectoris III-IV functional classes.
• Presence of uncompensated peripheral vestibular hyporeflexia due to previous vestibular neuronitis, labyrinthitis, labyrinth trauma.
• Presence at the time of screening of exacerbation of vestibular diseases with episodic vestibular syndrome.
• Meniere's disease.
• Established diagnosis of bilateral vestibular insufficiency.

You may not qualify if:

• The patient's decision to discontinue participation in the study.
• A decision by the investigator that continued participation in the study is contrary to the patient's best interests.
• A decision by the investigator's physician to exclude the patient from the study due to lack of adequate cooperation of the patient with the investigator's physician during the study.
• Diagnosis of acute (vestibular neuronitis, acute labyrinthitis, traumatic vestibulopathy, stroke with lesions of central and peripheral vestibular structures and others) and/or episodic vestibular syndromes (benign positional paroxysmal vertigo, Meniere's disease, vestibular migraine and others), bilateral vestibulopathy.
• Skipping taking the study drug (3 consecutive tablets or more than 6 tablets for each period of therapy).
• Omission of the active comparator (9 consecutive tablets or more than 17 tablets per therapy period).
• An adverse event requiring withdrawal of investigational therapy or limiting protocol procedures.
• The need to prescribe to the patient drugs from the "Prohibited Concomitant Therapies" section.
• Loss of communication with the patient.
• Pregnancy.
• Ineffectiveness of therapy (increase from baseline or no decrease in DHI total score and MVS mean score by 25% or more from baseline after another course of therapy).
• The patient was diagnosed with COVID-19 disease during the periods of primary and repeated therapy.

Sponsors & Collaborators

• Valenta Pharm JSC: lead

Study Sites (4)

Central Clinic LLC

Bryansk, 241050, Russia

RECRUITING

Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Healthcare of the Russian Federation

Kirov, 610027, Russia

RECRUITING

State Budgetary Institution of Healthcare of the City of Moscow "V.P. Demikhov City Clinical Hospital of the Department of Healthcare of the City of Moscow"

Moscow, 109263, Russia

RECRUITING

Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of the city of Smolensk"

Smolensk, 214025, Russia

RECRUITING

MeSH Terms

Conditions

Vertigo; Primary Dysautonomias

Interventions

cinnarizine, dimenhydrinate drug combination

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Autonomic Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: January 24, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

RU (4)