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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorValenta Pharm JSC

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Vespireit
  • Arlevert

Treatment groups

160 Participants
are divided into 2 treatment groups

Sponsors and collaborators