protocolSection identificationModule nctId: NCT06321341, orgStudyIdInfo id: BUSP-04-04-2023, briefTitle: Efficacy and Safety of Vespireit, Sustained-release Tablets, in Patients With Autonomic Dysfunction Syndrome Accompanied by Functional Vertigo, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-24, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Valenta Pharm JSC, class: INDUSTRY, descriptionModule briefSummary: Study of 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., conditionsModule conditions: Vertigo, conditions: Autonomic Dysfunction, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Vespireit, interventions name: Arlevert, outcomesModule primaryOutcomes measure: Change in Mean vertigo score (MVS) at Visit 1-3 of the Primary Therapy Period relative to baseline at Visit 1-1, secondaryOutcomes measure: Change in mean MVS score at Visit 1-2 of the Primary Therapy Period relative to baseline at Visit 1-1., secondaryOutcomes measure: Change in mean MVS score at Visits 2-2, 2-3, and 2-4 of the Retreatment Period compared with Visit 2-1., secondaryOutcomes measure: 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))., secondaryOutcomes measure: Percentage of patients with a ≥50% reduction in total DHI score on Visit 1-3 of the Primary Therapy Period relative to Visit 1-1., secondaryOutcomes measure: 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., secondaryOutcomes measure: Percentage of patients with a ≥25% reduction in total DHI score on Visit 1-3 of the Primary Therapy Period relative to Visit 1-1., secondaryOutcomes measure: 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., secondaryOutcomes measure: Change in total score on the DHI at Visit 1-3 of the Primary Therapy Period compared with Visit 1-1., secondaryOutcomes measure: Change in total score on the DHI at Visits 2-3 and 2-4 of the Retreatment Period compared with Visit 2-1., secondaryOutcomes measure: Change in total score on the DHI at the study participation completion visit compared to the score at Visit 1-1 in patients who completed the study according to the protocol (PP(response))., secondaryOutcomes measure: Change in digital rating scalescore from Visit 1-1 to Visits 1-2 and 1-3 in the Primary Treatment Period., secondaryOutcomes measure: Change in digital rating scale score from Visit 2-1 to Visits 2-2, 2-3, and 2-4 in the Retreatment Period., secondaryOutcomes measure: 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 Primary Therapy Period., secondaryOutcomes measure: 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., secondaryOutcomes measure: 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., secondaryOutcomes measure: 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., secondaryOutcomes measure: Change in VSS-SF total score at Visit 1-3 of the Primary Therapy Period relative to baseline at Visit 1-1., secondaryOutcomes measure: Change in VSS-SF total score at Visits 2- 3 and 2-4 of the Retreatment Period compared with Visit 2-1., secondaryOutcomes measure: Change in VSS-SF total score at the study participation completion visit compared with the score at Visit 1-1 in patients who completed the study according to protocol (PP(response))., secondaryOutcomes measure: Evaluation of therapy efficacy on the CGI-i scale by the patient at Visits 1-2 and 1-3 in the Primary Therapy Period., secondaryOutcomes measure: Evaluation of therapy efficacy on the CGI-i scale by the physician at Visits 1-2 and 1-3 in the Primary Therapy Period., secondaryOutcomes measure: 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., secondaryOutcomes measure: 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., secondaryOutcomes measure: 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), secondaryOutcomes measure: Duration of remission period after treatment in the Primary Therapy Period. Remission means absence of episodes of exacerbations (relapses), secondaryOutcomes measure: Clinically significant abnormalities on physical and/or neurologic examination, secondaryOutcomes measure: Adverse events (AEs), secondaryOutcomes measure: Serious adverse events (SAEs), secondaryOutcomes measure: Adverse reactions, secondaryOutcomes measure: Рatients with at least one AE, secondaryOutcomes measure: Patients discontinued due to AE, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Central Clinic LLC, status: RECRUITING, city: Bryansk, zip: 241050, country: Russian Federation, contacts name: Marina A Agafonova, MD, PhD, role: CONTACT, phone: +7-4832-72-58-28, email: agafonova.marina.sm@mail.ru, geoPoint lat: 53.25209, lon: 34.37167, locations facility: Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Healthcare of the Russian Federation, status: RECRUITING, city: Kirov, zip: 610027, country: Russian Federation, contacts name: Nadezhda S Trushnikova, MD, role: CONTACT, phone: +7-8332-62-75-68, email: uddefola@mail.ru, geoPoint lat: 58.59665, lon: 49.66007, locations facility: 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", status: RECRUITING, city: Moscow, zip: 109263, country: Russian Federation, contacts name: Kamila B Gadjialieva, MD, role: CONTACT, phone: +7-925-710-00-97, email: demikhovadzm@mail.ru, geoPoint lat: 55.75222, lon: 37.61556, locations facility: Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of the city of Smolensk", status: RECRUITING, city: Smolensk, zip: 214025, country: Russian Federation, contacts name: Natalia A Belyaeva, MD, role: CONTACT, phone: +7-4812-24-50-60, email: n.makar1973@mail.ru, geoPoint lat: 54.7818, lon: 32.0401, hasResults: False