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.
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.
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.
Parallel
Vespireit
DrugBuspirone
Arlevert
DrugDimenhydrinate + Cinnarizine
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)
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)
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)
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)
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)
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