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Tests treatment safety and results for Vertigo
Official title Efficacy and Safety of Vespireit, Prolonged-release Tablets, in Patients With Autonomic Dysfunction Syndrome Accompanied by Functional Vertigo
ClinicalTrials.gov ID: NCT06321341
What this study is testing
What is Vespireit?
Vespireit is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for vertigo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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...
You likely can't join 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.
- 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...
- Diagnosis of acute (vestibular neuronitis, acute labyrinthitis, traumatic vestibulopathy, stroke with lesions of central and peripheral vestibular...
- Skipping taking the study drug (3 consecutive tablets or more than 6 tablets for each period of therapy).
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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...
- 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...
- 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 how well it works...
- 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...
- 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...
What rules you out
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bryansk, Russia
- Kirov, Russia
- Moscow, Russia
- Smolensk, Russia
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bryansk, Russia; Kirov, Russia; Moscow, Russia; Smolensk, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.