Efficacy and Safety of Buspirone, Sustained-release Tablets, 15 mg in Patients With Autonomic Dysfunction Syndrome Accompanied by Vertigo

NCT05430217 | Completed Phase 3

• 1 other identifier: BUSP-03-03-2021
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 8

Brief Summary

Study to evaluate the efficacy and safety of Buspirone, sustained-release tablets, 15 mg in patients with autonomic dysfunction syndrome accompanied by vertigo

Conditions

Vertigo; Autonomic Dysfunction

Outcome Measures

Primary Outcomes (1)

• Frequency of response to therapy at Visit 5

  A number (%) of patients with reduction of ≥50% in the total Dizziness Handicap Inventory (DHI) score (25-item self-report questionnaire with total score from 0 to 100; higher scores mean a worse outcome) compared to Visit 1

  Visit 5 (day 28±1)

Secondary Outcomes (9)

• Frequency of response to therapy at Visits 2, 3, and 4.

  Visit 2 (day 7±1), Visit 3 (day 14±1), Visit 4 (day 21±1)

• Total score on the DHI Scale at Visits 2, 3, 4, and 5.

  Visit 2 (day 7±1), Visit 3 (day 14±1), Visit 4 (day 21±1), Visit 5 (day 28±1)

• Change in total DHI score on Visits 2, 3, 4, and 5 compared to Visit 1

  Visit 2 (day 7±1), Visit 3 (day 14±1), Visit 4 (day 21±1), Visit 5 (day 28±1)

• Proportion of patients with a 30% or greater reduction in DHI score compared to baseline by Visit 2, 3, 4, 5

  Visit 2 (day 7±1), Visit 3 (day 14±1), Visit 4 (day 21±1), Visit 5 (day 28±1)

• Time elapsed before the total DHI score decreased by 50% or more from baseline

  Day 1 - Day 28±1

Other Outcomes (42)

• Safety and Tolerability: adverse event (AE) number and frequency

  From the screening to Visit 6 (day 35±1)

• Safety and Tolerability: serious AEs (SAEs) number and frequency

  From the screening to Visit 6 (day 35±1)

• Safety and Tolerability: AE and SAE causal relationship

  From the screening to Visit 6 (day 35±1)

Study Arms (2)

Buspirone, sustained-release tablets, 15 mg

EXPERIMENTAL

15 mg/day

Drug: Buspirone

Placebo

PLACEBO COMPARATOR

1 placebo tablet/day

Drug: Placebo

Interventions

Buspirone DRUG

1 tablet (15 mg) once per day for 28 days

Buspirone, sustained-release tablets, 15 mg

Placebo DRUG

1 placebo tablet once per day for 28 days

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signing and dating the patient's Informed Consent Form.
• Women and men between the ages of 18 and 65, inclusive, at the time of signing the Informed Consent Form.
• Clinical diagnosis: G90.8 Other autonomic nervous system disorders or G90.9 Autonomic nervous system disorder not specified.
• Presence of dizziness, total DHI score from 36 to 52 points inclusive.
• For women of preserved reproductive potential, a negative pregnancy test and agreement to use approved contraceptive methods for the duration of study participation, beginning at visit 0, and for 3 weeks after study termination; for men, agreement to use approved contraceptive methods for the duration of study participation and for 3 weeks after study termination.
• Allowed contraceptive methods in this study are: intrauterine device, barrier method, or dual barrier method (condom or occlusion cap (diaphragm or cervical/vaulted cap) plus spermicide). Hormonal contraception is not permitted due to insufficient data on drug interactions of buspirone.
• Women with infertility (menopausal (defined as not menstruating for at least 2 years or more) or with documented surgical sterilization (hysterectomy, bilateral oophorectomy, fallopian tubal ligation) and men with documented infertility or vasectomy are also eligible for participation.

You may not qualify if:

• Known or suspected hypersensitivity to the active ingredient or any of the excipients of the study drug/placebo.
• Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
• Cumulative score \> 2 on the Suicide Risk Assessment Scale.
• Cumulative score \> 16 on the Hamilton Scale.
• Chronic heart failure New York Heart Association (NYHA) functional class III-IV, angina III-IV.
• Syncopal and presyncopal conditions, including a history.
• Acute cardiovascular disease or surgery (myocardial infarction, angioplasty, aortocoronary/mammary coronary artery bypass surgery, unstable angina, etc) less than 6 months before the screening visit.
• Acute cerebral circulation disorders and/or transient ischemic attacks less than 6 months before the screening visit date.
• Cardiac rhythm and conduction disorders, including a history. An established artificial pacemaker.
• Established diagnosis of liver failure, including a history and/or changes in liver enzyme activity:
• increased aspartate aminotransferase (AST), alanine aminotransferase (ALT) more than 2.5 times the upper limit of normal,
• increase in the level of total bilirubin more than 1.5 times above the upper limit of normal;
• Prothrombin time \>18 s.
• Chronic kidney disease history of stage IIIa-V (as defined by the National Kidney Foundation/Kidney Disease Outcomes Quality Initiative, NKF/KDOQI, 2006).
• \. Glomerular filtration rate (GFR) ≤ 60 mL/min, calculated using the CKD-EPI equation, based on serum creatinine levels at screening.

Sponsors & Collaborators

• Valenta Pharm JSC: lead

Study Sites (8)

Regional budgetary health care institution "Ivanovo Regional Clinical Hospital"

Saint Petersburg, 152040, Russia

Location

Limited Liability Company "Research Center Eco-Security"

Saint Petersburg, 191119, Russia

Location

Limited Liability Company "X7 Clinical Research"

Saint Petersburg, 194156, Russia

Location

Limited Liability Company "Research Center Eco-Safety"

Saint Petersburg, 196143, Russia

Location

Limited Liability Company "MK-Med"

Saint Petersburg, 197372, Russia

Location

Saint Petersburg State Budgetary Institution of Healthcare "City Hospital No. 40 of Kurortny District"

Saint Petersburg, 197706, Russia

Location

St. Petersburg State Budgetary Health Institution "City Polyclinic No. 106"

Saint Petersburg, 198328, Russia

Location

Limited Liability Company "MART"

Saint Petersburg, 199178, Russia

Location

MeSH Terms

Conditions

Vertigo; Primary Dysautonomias

Interventions

Buspirone

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Autonomic Nervous System Diseases

Intervention Hierarchy (Ancestors)

Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 24, 2022
• Study Start: January 28, 2022
• Primary Completion: May 9, 2022
• Study Completion: May 9, 2022
• Last Updated: June 24, 2022

Record last verified: 2022-06

Locations

RU (8)