NCT06321341招募中4 期
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.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Change in Mean vertigo score (MVS) at Visit 1-3 of the Initial Treatment Phase relative to baseline at Visit 1-1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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-
- •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.
- 另有 19 项未显示
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Vespireit (Drug)
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.
干预措施: Arlevert (Drug)
结局指标
主要结局
Change in Mean vertigo score (MVS) at Visit 1-3 of the Initial Treatment Phase relative to baseline at Visit 1-1
时间窗: 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)
次要结局
- 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))
- 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.(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.(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.(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.(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)).(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.(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.(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.(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.(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.(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.(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.(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.(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)).(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.(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.(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.(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.(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)(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)(From Day 1 to the end of the study)
- Clinically significant abnormalities on physical and/or neurologic examination(Day 1 - Day 28±1 (primary treatment period), Day 1 - Day 42 ±1 (retreatment period))
- Adverse events (AEs)(Day 1 - Day 28±1 (primary treatment period), Day 1 - Day 42 ±1 (retreatment period))
- Serious adverse events (SAEs)(Day 1 - Day 28±1 (primary treatment period), Day 1 - Day 42 ±1 (retreatment period))
- Adverse reactions(Day 1 - Day 28±1 (primary treatment period), Day 1 - Day 42 ±1 (retreatment period))
- Рatients with at least one AE(Day 1 - Day 28±1 (primary treatment period), Day 1 - Day 42 ±1 (retreatment period))
- Patients discontinued due to AE(Day 1 - Day 28±1 (primary treatment period), Day 1 - Day 42 ±1 (retreatment period))
研究者
研究点 (4)
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