Actively Recruiting
Efficacy and Safety of Vespireit, Prolonged-release Tablets, in Patients With Autonomic Dysfunction Syndrome Accompanied by Functional Vertigo
Led by Valenta Pharm JSC · Updated on 2025-06-15
160
Participants Needed
4
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Efficacy and Safety of Vespireit, Prolonged-release Tablets, in Patients With Autonomic Dysfunction Syndrome Accompanied by Functional Vertigo
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient signed and dated the Informed Consent Form.
- Males and females aged 18 to 65 years inclusive at the time of consent.
- Clinical diagnosis of other or unspecified autonomic nervous system disorders (G90.8 or G90.9).
- Diagnosed chronic functional vertigo per Barani Society criteria: total DHI score of 31 points or higher; mean MVS score of 1.5 points or higher.
- For women of childbearing potential, negative pregnancy test and consent to use authorized contraception during the study and for 3 weeks after.
- For men, consent to use authorized contraception during the study and for 3 weeks after.
- Postmenopausal women (2 or more years of amenorrhea) or surgically sterile women, and men with documented infertility or vasectomy are eligible.
You will not qualify if you...
- Known or suspected hypersensitivity to the study drugs or their components.
- Lactose intolerance, lactase deficiency, or glucose-galactose malabsorption.
- Suicide Risk Assessment Scale score greater than 2.
- Chronic heart failure class III-IV or angina pectoris class III-IV.
- Uncompensated peripheral vestibular hyporeflexia from previous vestibular illnesses.
- Exacerbation of vestibular diseases with episodic vestibular syndrome at screening.
- Meniere's disease or bilateral vestibular insufficiency.
- Syncopal or presyncopal conditions at screening.
- Acute cardiovascular events or surgeries within 6 months before screening.
- Acute cerebral circulatory disorders or transient ischemic attacks within 6 months before screening.
- Significant cardiac rhythm or conduction abnormalities, or artificial pacemaker.
- Clinically significant ECG abnormalities.
- Liver failure or elevated liver enzymes beyond specified limits.
- Renal failure or low creatinine clearance below thresholds.
- Pyloroduodenal obstruction or prostatic hyperplasia.
- Thyroid function disorders.
- Parkinson's disease.
- Severe ischemic heart disease.
- Uncontrolled hypertension or diabetes mellitus in decompensation.
- Myasthenia gravis.
- Closed-angle glaucoma or suspected elevated intraocular pressure.
- Systemic connective tissue or autoimmune diseases.
- History or suspicion of elevated intracranial pressure.
- Urinary retention due to urethral or prostate disease.
- Planned surgical or endovascular treatment within 15 months.
- Epilepsy or history of convulsive seizures.
- Alcohol, drug dependence, or substance abuse within last 6 months.
- History of schizophrenia, schizoaffective disorder, or bipolar disorder.
- Infectious diseases including tuberculosis, hepatitis B and C, HIV, or syphilis.
- Recent surgical procedures within 6 months.
- Recent therapy for cognitive impairment, balance disorders, or dizziness within 21 days before Visit 1-1.
- Use of certain medications including MAO inhibitors, SSRIs, cinnarizine, dimenhydrinate, CYP3A4 inhibitors/inducers, cimetidine, warfarin, phenytoin, propranolol within specified time frames.
- History of malignant neoplasm except certain cured cancers.
- Decompensated somatic or neuropsychiatric diseases affecting compliance or assessment.
- Pregnant or breastfeeding women or planning pregnancy within 15 months.
- Use of prohibited concomitant medications.
- Participation in another clinical trial within 3 months prior to screening.
- Unwillingness or inability to comply with protocol procedures.
- Other conditions judged by investigator as exclusionary.
- Diagnosis or symptoms of COVID-19 at screening or within 14 days prior with positive test.
- Patient decision to discontinue or investigator decision to exclude for best interests.
- Inclusion violations, poor cooperation, skipping study medication beyond allowed limits.
- Adverse events requiring withdrawal.
- Pregnancy during study.
- Ineffectiveness of therapy as defined by scoring criteria.
- COVID-19 diagnosis during therapy periods.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Central Clinic LLC
Bryansk, Russia, 241050
Actively Recruiting
2
Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Healthcare of the Russian Federation
Kirov, Russia, 610027
Actively Recruiting
3
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, 109263
Actively Recruiting
4
Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of the city of Smolensk"
Smolensk, Russia, 214025
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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