nctId: NCT06321341 id: BUSP-04-04-2023 briefTitle: Efficacy and Safety of Vespireit, Sustained-release Tablets, in Patients With Autonomic Dysfunction Syndrome Accompanied by Functional Vertigo overallStatus: RECRUITING date: 2024-01-24 date: 2026-12-31 date: 2026-12-31 date: 2024-03-20 date: 2024-03-20 name: Valenta Pharm JSC class: INDUSTRY 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. conditions: Vertigo conditions: Autonomic Dysfunction studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 160 type: ESTIMATED name: Vespireit name: Arlevert measure: Change in Mean vertigo score (MVS) at Visit 1-3 of the Primary Therapy Period relative to baseline at Visit 1-1 measure: Change in mean MVS score at Visit 1-2 of the Primary Therapy Period relative to baseline at Visit 1-1. measure: Change in mean MVS score at Visits 2-2, 2-3, and 2-4 of the Retreatment Period compared with Visit 2-1. 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)). 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. 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. 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. 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. measure: Change in total score on the DHI at Visit 1-3 of the Primary Therapy Period compared with Visit 1-1. measure: Change in total score on the DHI at Visits 2-3 and 2-4 of the Retreatment Period compared with Visit 2-1. 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)). measure: Change in digital rating scalescore from Visit 1-1 to Visits 1-2 and 1-3 in the Primary Treatment Period. measure: Change in digital rating scale score from Visit 2-1 to Visits 2-2, 2-3, and 2-4 in the Retreatment Period. 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. 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. 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. 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. measure: Change in VSS-SF total score at Visit 1-3 of the Primary Therapy Period relative to baseline at Visit 1-1. measure: Change in VSS-SF total score at Visits 2- 3 and 2-4 of the Retreatment Period compared with Visit 2-1. 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)). 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. 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. 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. 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. 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) measure: Duration of remission period after treatment in the Primary Therapy Period. Remission means absence of episodes of exacerbations (relapses) measure: Clinically significant abnormalities on physical and/or neurologic examination measure: Adverse events (AEs) measure: Serious adverse events (SAEs) measure: Adverse reactions measure: Рatients with at least one AE measure: Patients discontinued due to AE sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Central Clinic LLC status: RECRUITING city: Bryansk zip: 241050 country: Russian Federation name: Marina A Agafonova, MD, PhD role: CONTACT phone: +7-4832-72-58-28 email: agafonova.marina.sm@mail.ru lat: 53.25209 lon: 34.37167 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 name: Nadezhda S Trushnikova, MD role: CONTACT phone: +7-8332-62-75-68 email: uddefola@mail.ru lat: 58.59665 lon: 49.66007 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 name: Kamila B Gadjialieva, MD role: CONTACT phone: +7-925-710-00-97 email: demikhovadzm@mail.ru lat: 55.75222 lon: 37.61556 facility: Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of the city of Smolensk" status: RECRUITING city: Smolensk zip: 214025 country: Russian Federation name: Natalia A Belyaeva, MD role: CONTACT phone: +7-4812-24-50-60 email: n.makar1973@mail.ru lat: 54.7818 lon: 32.0401 hasResults: False