VertigoPhase 4NCT06321341

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

A Phase 4 study testing Vespireit and Arlevert in people with Vertigo and Autonomic Dysfunction, run by Valenta Pharm JSC at 4 sites in Russia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Vertigo, Autonomic Dysfunction
What is being tested?: Vespireit and Arlevert
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 4 sitesRussia
Study dates: 24 Jan 2024to 31 Dec 2026
Phase: Phase 4
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.
Non-inclusion Criteria:
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.
Syncopal and presyncopal conditions at the time of screening.
Acute cardiovascular disease or surgical interventions (myocardial infarction, angioplasty, aortocoronary/mammary coronary heart bypass, unstable angina, and others) less than 6 months prior to the date of the Screening Visit.
Acute cerebral circulatory disorders and/or transient ischemic attacks less than 6 months prior to the date of the Screening Visit.
Hemodynamically significant cardiac rhythm and conduction abnormalities, including a history of cardiac rhythm and conduction abnormalities.
An installed artificial pacemaker.
Clinically significant ECG abnormalities;
Established diagnosis of liver failure, including history and/or altered laboratory values: increase in aspartateaminotransferase (AST), alanineaminotransferase (ALT) more than 2.5 times relative to the upper limit of normal, increase in total bilirubin more than 1.5 times above the upper limit of normal;
Established diagnosis of renal failure of any severity and/or creatinine clearance calculated by the Cockcroft-Gault formula at screening < 80 ml/min in women and < 90 ml/min in men.
Pyloroduodenal obstruction based on history.
Prostatic hyperplasia.
Thyroid function disorder according to examination and clinical and laboratory tests.
Parkinson's disease according to anamnesis.
Severe ischemic heart disease.
Uncontrolled hypertension with systolic blood pressure > 180 mm Hg and/or diastolic blood pressure > 110 mm Hg, or blood pressure (BP) at screening ≥140/90 or ≤ 100/60 mm Hg.
Uncontrolled diabetes mellitus, diabetes mellitus in decompensation.
Myasthenia gravis.
Closed-angle glaucoma.
Suspicion of elevated intraocular pressure at the time of screening.
Systemic connective tissue diseases.
Autoimmune diseases.
History or suspected elevated intracranial pressure.
Urinary retention due to a history of urethral and/or prostate disease.
Need for surgical and/or endovascular treatment in the next 15 months.
Epilepsy or convulsive seizures, including history of seizures.
Alcoholism, drug dependence, substance abuse in the history and/or at the time of screening (alcoholism - use of more than 30 ml of ethyl alcohol per day during the last 6 months; drug dependence - use of any narcotic substances in any doses during the last 6 months; substance abuse - use of any psychoactive substances in any doses during the last 6 months).
History of schizophrenia, schizoaffective disorder, bipolar disorder.
Tuberculosis, hepatitis B and C, HIV infection, syphilis, history or by screening.
Conditions after surgical procedures, if less than 6 months have passed since the intervention.
Therapy for cognitive impairment, balance disorders, and dizziness 21 days or less prior to Visit 1-1 date.
Use of an irreversible MAO inhibitor within 14 days or a reversible MAO inhibitor within 1 day prior to Visit 1-1.
Therapy with the following drugs and drug groups: 7 days or less before screening: Selective serotonin reuptake inhibitors (SSRIs) and selective serotonin and norepinephrine reuptake inhibitors (SSRIs); Cinnarizine and/or dimenhydrinate preparations; Cytochrome P450 3A4 (Cytochrome P450 3A4, CYP3A4) inhibitors and inducers: Erythromycin, itraconazole, nefazodone, diltiazem, verapamil, etc.; Cimetidine, warfarin, phenytoin, propranolol. Monoamine oxidase inhibitors (MAOIs): concomitant use of MAO inhibitors is prohibited, as well as taking the drug earlier than 14 days after withdrawal of an irreversible MAO inhibitor, or less than 1 day after withdrawal of a reversible MAO inhibitor.
Presence of a history of malignant neoplasm, except in patients who have had no disease in the past 5 years, patients with completely cured basal cell skin cancer, or completely cured carcinoma in situ.
Decompensated somatic diseases that, in the opinion of the investigator, would prevent the patient from complying with the regimen prescribed by the study protocol, or would prevent assessment of the efficacy of therapy and compliance according to the protocol, or could skew the results of the study.
Decompensated neuropsychiatric diseases, including multiple sclerosis, Parkinson's disease, endogenous depression, and others, which in the opinion of the investigator would prevent the patient from complying with the regimen prescribed by the study protocol, or would prevent assessment of therapy efficacy and compliance according to the protocol, or could skew the results of the study.
Female patients who are pregnant or breastfeeding or planning pregnancy within the next 15 months.
Patients requiring prohibited concomitant medications.
Participation in another clinical trial within the last 3 months prior to the date of the Screening Visit.
Patient's unwillingness or inability to comply with protocol procedures (in the opinion of the investigator).
Other conditions that, in the judgment of the investigator, preclude the patient's inclusion in the study.
The patient is diagnosed with COVID-19 disease at the time of screening or Randomization Visit; or the presence of symptoms of acute respiratory infections or COVID-19 within 14 days prior to screening and a positive rapid test for COVID-19 at screening.

Who cannot join

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.
The patient is included in the study in violation of the inclusion and non-inclusion criteria.
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).

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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.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Russia4 sites, 4 recruiting

Central Clinic LLC
Bryansk, 241050
Marina A Agafonova, MD, PhD, +7-4832-72-58-28, agafonova.marina.sm@mail.ru
Recruiting
Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Healthcare of the Russian Federation
Kirov, 610027
Nadezhda S Trushnikova, MD, +7-8332-62-75-68, uddefola@mail.ru
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
Kamila B Gadjialieva, MD, +7-925-710-00-97, demikhovadzm@mail.ru
Recruiting
Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of the city of Smolensk"
Smolensk, 214025
Natalia A Belyaeva, MD, +7-4812-24-50-60, n.makar1973@mail.ru
Recruiting

Other trials in Russia

About this study

Official title: 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.

Conditions: Vertigo, Autonomic Dysfunction
Being tested: Vespireit, Arlevert
Medical subject headings: Vertigo, Primary Dysautonomias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VespireitDrug
Buspirone
ArlevertDrug
Dimenhydrinate + Cinnarizine

Study groups in NCT06321341
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Arlevert

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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.
Assessment performed using MVS (12-item scale with score from 0 to 4 for each item; higher scores mean a worse outcome)
Measured: 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.
Assessment performed using MVS (12-item scale with score from 0 to 4 for each item; higher scores mean a worse outcome)
Measured: 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)).
Assessment performed using MVS (12-item scale with score from 0 to 4 for each item; higher scores mean a worse outcome)
Measured: 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.
Assessment performed using DHI (25-item self-report questionnaire with total score from 0 to 100; higher scores mean a worse outcome)
Measured: 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.
Assessment performed using DHI (25-item self-report questionnaire with total score from 0 to 100; higher scores mean a worse outcome)
Measured: Day 1 - Day 42 ±1 (retreatment period)
Percentage of patients with a ≥25% reduction in total DHI score on Visit 1-3 of the Initial Treatment Phase relative to Visit 1-1.
Assessment performed using DHI (25-item self-report questionnaire with total score from 0 to 100; higher scores mean a worse outcome)
Measured: Day 1 - Day 28±1
Percentage of patients with a ≥25% reduction in total DHI score on Visits 2-3 and 2-4 of the Retreatment Period relative to Visit 2-1.
Assessment performed using DHI (25-item self-report questionnaire with total score from 0 to 100; higher scores mean a worse outcome)
Measured: Day 1 - Day 42 ±1 (retreatment period)
Change in total score on the DHI at Visit 1-3 of the Initial Treatment Phase compared with Visit 1-1.
Assessment performed using DHI (25-item self-report questionnaire with total score from 0 to 100; higher scores mean a worse outcome)
Measured: Day 1 - Day 28±1
Change in total score on the DHI at Visits 2-3 and 2-4 of the Retreatment Period compared with Visit 2-1.
Assessment performed using DHI (25-item self-report questionnaire with total score from 0 to 100; higher scores mean a worse outcome)
Measured: Day 1 - Day 42 ±1 (retreatment period)
Change in total score on the DHI at the end-of-study visit compared to the score at Visit 1-1 in patients who completed the study according to the protocol (PP(response)).
Assessment performed using DHI (25-item self-report questionnaire with total score from 0 to 100; higher scores mean a worse outcome)
Measured: Day 1 - Day 28±1
Change in digital rating scalescore from Visit 1-1 to Visits 1-2 and 1-3 in the Primary Treatment Period.
Assessment performed using digital rating scale (from minimum of 0 to maximum of 10 points; higher scores mean a worse outcome)
Measured: Day 1 - Day 28±1
Change in digital rating scale score from Visit 2-1 to Visits 2-2, 2-3, and 2-4 in the Retreatment Period.
Assessment performed using digital rating scale (from minimum of 0 to maximum of 10 points; higher scores mean a worse outcome)
Measured: Day 1 - Day 42 ±1 (retreatment period)
Assessment of quality of life in patients with autonomic dysfunction syndrome accompanied by functional vertigo using the EQ-5D questionnaire at Visit 1-3 of the Initial Treatment Phase.
Assessment performed using EQ-5D questionnaire (5-item self-report questionnaire with total score from 0 to 100; higher scores mean a better outcome)
Measured: Day 1 - Day 28±1
Assessment of quality of life in patients with autonomic dysfunction syndrome accompanied by functional vertigo using the EQ-5D questionnaire at Visits 2-3 and 2-4 of the Retreatment Period.
Assessment performed using EQ-5D questionnaire (5-item self-report questionnaire with total score from 0 to 100; higher scores mean a better outcome)
Measured: Day 1 - Day 42 ±1 (retreatment period)
Change in total score on the Hamilton Anxiety Rating Scale HARS at Visit 1-3 of the Primary Treatment Period compared with Visit 1-1.
Assessment performed using HARS (21-item scale with total score from 0 to 56; higher scores mean a worse outcome)
Measured: Day 1 - Day 28±1
Change in total score on the Hamilton Anxiety Rating Scale HARS at Visits 2-3 and 2-4 of the Retreatment Period compared with Visit 2-1.
Assessment performed using HARS (21-item scale with total score from 0 to 56; higher scores mean a worse outcome)
Measured: Day 1 - Day 42 ±1 (retreatment period)
Change in VSS-SF total score at Visit 1-3 of the Initial Treatment Phase relative to baseline at Visit 1-1.
Assessment performed using VSS-SF score (15-item scale with score from 0 to 4 for each item; higher scores mean a worse outcome)
Measured: Day 1 - Day 28±1
Change in VSS-SF total score at Visits 2- 3 and 2-4 of the Retreatment Period compared with Visit 2-1.
Assessment performed using VSS-SF score (15-item scale with score from 0 to 4 for each item; higher scores mean a worse outcome)
Measured: Day 1 - Day 42 ±1 (retreatment period)
Change in VSS-SF total score at the end-of-study visit compared with the score at Visit 1-1 in patients who completed the study according to protocol (PP(response)).
Assessment performed using VSS-SF score (15-item scale with score from 0 to 4 for each item; higher scores mean a worse outcome)
Measured: From Day 1 to the end of the study
Evaluation of therapy efficacy on the CGI-i scale by the patient at Visits 1-2 and 1-3 in the Initial Treatment Phase.
Assessment performed using CGI-i scale (scale from 0 to 7; higher scores mean a worse outcome)
Measured: Day 1 - Day 28±1
Evaluation of therapy efficacy on the CGI-i scale by the physician at Visits 1-2 and 1-3 in the Primary Therapy Period.
Assessment performed using CGI-i scale (scale from 0 to 7; higher scores mean a worse outcome)
Measured: Day 1 - Day 28±1
Evaluation of therapy efficacy on the CGI-i scale by the patient at Visits 2-2, 2-3, and 2-4 in the Retreatment Period.
Assessment performed using CGI-i scale (scale from 0 to 7; higher scores mean a worse outcome)
Measured: Day 1 - Day 42 ±1 (retreatment period)
Evaluation of the effectiveness of therapy on the CGI-i scale by the physician at Visits 2-2, 2-3, 2-4 in the Re-Treatment Period.
Assessment performed using CGI-i scale (scale from 0 to 7; higher scores mean a worse outcome)
Measured: Day 1 - Day 42 ±1 (retreatment period)
Proportion of patients with exacerbation (relapse) of the disease after treatment in the Primary Treatment Period during the entire follow-up period (until the visit of completion of participation in the study)
An exacerbation (relapse) is defined as a total DHI score ≥ 31 points
Measured: From Day 1 to the end of the study
Duration of remission period after treatment in the Initial Treatment Phase. Remission means absence of episodes of exacerbations (relapses)
The duration of the remission period is the time from the day of completion of primary therapy to the day of the visit confirming an exacerbation (relapse) or to the day of completion of the study (if there is no exacerbation (relapse))
Measured: From Day 1 to the end of the study
Clinically significant abnormalities on physical and/or neurologic examination
Number and percentage of patients with clinically significant abnormalities found during physical and/or neurologic examination
Measured: Day 1 - Day 28±1 (primary treatment period), Day 1 - Day 42 ±1 (retreatment period)
Adverse events (AEs)
Frequency of AEs for all treatment periods stratified by severity and frequency
Measured: Day 1 - Day 28±1 (primary treatment period), Day 1 - Day 42 ±1 (retreatment period)
Serious adverse events (SAEs)
Frequency of SAEs
Measured: Day 1 - Day 28±1 (primary treatment period), Day 1 - Day 42 ±1 (retreatment period)
Adverse reactions
Frequency of AEs and SAEs associated with the use of investigational drugs
Measured: Day 1 - Day 28±1 (primary treatment period), Day 1 - Day 42 ±1 (retreatment period)
Рatients with at least one AE
Proportion of patients with at least one AE registered
Measured: Day 1 - Day 28±1 (primary treatment period), Day 1 - Day 42 ±1 (retreatment period)
Patients discontinued due to AE
Percentage of patients who discontinued treatment due to the occurrence of AE
Measured: Day 1 - Day 28±1 (primary treatment period), Day 1 - Day 42 ±1 (retreatment period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jan 202431 Dec 2026

First posted20 Mar 2024
Study start24 Jan 2024
Primary completion31 Dec 2026 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for VertigoStudies of the same condition, open and under way.
More trials run by Valenta Pharm JSCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 160 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06321341
Sponsor's protocol ID: BUSP-04-04-2023
Status last verified: Jun 2025
First submitted: 13 Mar 2024
Last updated: 15 Jun 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Recruiting
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
Hearing Loss, Dizziness
Not yet recruiting
Epley Versus Semont-plus Maneuver for Benign Paroxysmal Positional Vertigo
Benign Paroxysmal Positional Vertigo (BPPV)
Active, not recruitingObservational study
China Dizziness and Vertigo Cohort Study （VERIDICAL STUDY）
Vertigo, Vestibular Diseases
Enrolling by invitationObservational study
Comparison of Two Mechanical Rotation Chairs With Diagnostics of Benign Paroxysmal Positional Vertigo.
Benign Paroxysmal Positional Vertigo (BPPV)
Not yet recruiting
The Effect of Chewing Gum on Dizziness in Patients Diagnosed With Posterior Canal Benign Paroxysmal Positional Vertigo in the Emergency Department
Vertigo Benign Positional, Dizziness

All Vertigo trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT06321341
Acronym / sponsor ID: BUSP-04-04-2023
Conditions: Vertigo, Autonomic Dysfunction
Phase: Phase 4
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 160 participants (estimated)
Lead sponsor: Valenta Pharm JSCIndustry (pharma, biotech, devices)
Study start: 24 Jan 2024 (actual)
Primary completion: 31 Dec 2026 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 20 Mar 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Vespireit, prolonged-release tablets, 15 mg	Experimental	Drug: VespireitDosage 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.
Arlevert, tablets, 40 mg + 20 mg	Active comparator	Drug: ArlevertDosage 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (56 listed)

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.

Key exclusion criteria (13 listed)

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.
The patient is included in the study in violation of the inclusion and non-inclusion criteria.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VespireitBuspirone	Drug	Vespireit, prolonged-release tablets, 15 mg
ArlevertDimenhydrinate + Cinnarizine	Drug	Arlevert, tablets, 40 mg + 20 mg

Primary outcome

Change in Mean vertigo score (MVS) at Visit 1-3 of the Initial Treatment Phase relative to baseline at Visit 1-1
Time frame: Day 1 - Day 28±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)

31 secondary outcomes

Change in mean MVS score at Visit 1-2 of the Initial Treatment Phase relative to baseline at Visit 1-1.
Time frame: 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.
Time frame: 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)).
Time frame: 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.
Time frame: 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.
Time frame: Day 1 - Day 42 ±1 (retreatment period)
Percentage of patients with a ≥25% reduction in total DHI score on Visit 1-3 of the Initial Treatment Phase relative to Visit 1-1.
Time frame: Day 1 - Day 28±1
Percentage of patients with a ≥25% reduction in total DHI score on Visits 2-3 and 2-4 of the Retreatment Period relative to Visit 2-1.
Time frame: Day 1 - Day 42 ±1 (retreatment period)
Change in total score on the DHI at Visit 1-3 of the Initial Treatment Phase compared with Visit 1-1.
Time frame: Day 1 - Day 28±1
Change in total score on the DHI at Visits 2-3 and 2-4 of the Retreatment Period compared with Visit 2-1.
Time frame: Day 1 - Day 42 ±1 (retreatment period)
Change in total score on the DHI at the end-of-study visit compared to the score at Visit 1-1 in patients who completed the study according to the protocol (PP(response)).
Time frame: Day 1 - Day 28±1
Change in digital rating scalescore from Visit 1-1 to Visits 1-2 and 1-3 in the Primary Treatment Period.
Time frame: Day 1 - Day 28±1
Change in digital rating scale score from Visit 2-1 to Visits 2-2, 2-3, and 2-4 in the Retreatment Period.
Time frame: Day 1 - Day 42 ±1 (retreatment period)
Assessment of quality of life in patients with autonomic dysfunction syndrome accompanied by functional vertigo using the EQ-5D questionnaire at Visit 1-3 of the Initial Treatment Phase.
Time frame: Day 1 - Day 28±1
Assessment of quality of life in patients with autonomic dysfunction syndrome accompanied by functional vertigo using the EQ-5D questionnaire at Visits 2-3 and 2-4 of the Retreatment Period.
Time frame: Day 1 - Day 42 ±1 (retreatment period)
Change in total score on the Hamilton Anxiety Rating Scale HARS at Visit 1-3 of the Primary Treatment Period compared with Visit 1-1.
Time frame: Day 1 - Day 28±1
Change in total score on the Hamilton Anxiety Rating Scale HARS at Visits 2-3 and 2-4 of the Retreatment Period compared with Visit 2-1.
Time frame: Day 1 - Day 42 ±1 (retreatment period)
Change in VSS-SF total score at Visit 1-3 of the Initial Treatment Phase relative to baseline at Visit 1-1.
Time frame: Day 1 - Day 28±1
Change in VSS-SF total score at Visits 2- 3 and 2-4 of the Retreatment Period compared with Visit 2-1.
Time frame: Day 1 - Day 42 ±1 (retreatment period)
Change in VSS-SF total score at the end-of-study visit compared with the score at Visit 1-1 in patients who completed the study according to protocol (PP(response)).
Time frame: From Day 1 to the end of the study
Evaluation of therapy efficacy on the CGI-i scale by the patient at Visits 1-2 and 1-3 in the Initial Treatment Phase.
Time frame: Day 1 - Day 28±1
Evaluation of therapy efficacy on the CGI-i scale by the physician at Visits 1-2 and 1-3 in the Primary Therapy Period.
Time frame: Day 1 - Day 28±1
Evaluation of therapy efficacy on the CGI-i scale by the patient at Visits 2-2, 2-3, and 2-4 in the Retreatment Period.
Time frame: Day 1 - Day 42 ±1 (retreatment period)
Evaluation of the effectiveness of therapy on the CGI-i scale by the physician at Visits 2-2, 2-3, 2-4 in the Re-Treatment Period.
Time frame: Day 1 - Day 42 ±1 (retreatment period)
Proportion of patients with exacerbation (relapse) of the disease after treatment in the Primary Treatment Period during the entire follow-up period (until the visit of completion of participation in the study)
Time frame: From Day 1 to the end of the study
Duration of remission period after treatment in the Initial Treatment Phase. Remission means absence of episodes of exacerbations (relapses)
Time frame: From Day 1 to the end of the study
Clinically significant abnormalities on physical and/or neurologic examination
Time frame: Day 1 - Day 28±1 (primary treatment period), Day 1 - Day 42 ±1 (retreatment period)
Adverse events (AEs)
Time frame: Day 1 - Day 28±1 (primary treatment period), Day 1 - Day 42 ±1 (retreatment period)
Serious adverse events (SAEs)
Time frame: Day 1 - Day 28±1 (primary treatment period), Day 1 - Day 42 ±1 (retreatment period)
Adverse reactions
Time frame: Day 1 - Day 28±1 (primary treatment period), Day 1 - Day 42 ±1 (retreatment period)
Рatients with at least one AE
Time frame: Day 1 - Day 28±1 (primary treatment period), Day 1 - Day 42 ±1 (retreatment period)
Patients discontinued due to AE
Time frame: Day 1 - Day 28±1 (primary treatment period), Day 1 - Day 42 ±1 (retreatment period)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Central Clinic LLC

Bryansk, Russia

+7-4832-72-58-28

agafonova.marina.sm@mail.ru

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

Kirov, Russia

+7-8332-62-75-68

uddefola@mail.ru

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, Russia

+7-925-710-00-97

demikhovadzm@mail.ru

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vespireit and Arlevert in people with Vertigo and Autonomic Dysfunction, run by Valenta Pharm JSC at 4 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 56 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Mean vertigo score (MVS) at Visit 1-3 of the Initial Treatment Phase relative to baseline at Visit 1-1 (time frame: Day 1 - Day 28±1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06321341.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.