VertigoPhase 3NCT05430217
Efficacy and Safety of Buspirone, Sustained-release Tablets, 15 mg in Patients With Autonomic Dysfunction Syndrome Accompanied by Vertigo
A Phase 3 study testing Buspirone in people with Vertigo and Autonomic Dysfunction, run by Valenta Pharm JSC at 8 sites in Russia.
Trial summary
Study to evaluate the efficacy and safety of Buspirone, sustained-release tablets, 15 mg in patients with autonomic dysfunction syndrome accompanied by vertigo Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vertigo, Autonomic Dysfunction
- What is being tested?
- Buspirone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 268 participants
- Where
- 8 sitesRussia
- Study dates
- 28 Jan 2022to 9 May 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 48Show fewer
- 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).
- 12. Glomerular filtration rate (GFR) ≤ 60 mL/min, calculated using the CKD-EPI equation, based on serum creatinine levels at screening.
- 13. Diabetes mellitus of moderate and severe severity, as well as mild subcompensation and decompensation.
- 14. Myasthenia gravis. 15. Glaucoma. 16. Systemic connective tissue diseases. 17. Autoimmune diseases. 18. The need for surgical and/or endovascular treatment in the next 3 months. 19. Epilepsy or seizures of unclear etiology, including a history of seizures. 20. Alcoholism, drug addiction, substance abuse in the history and/or at the time of screening (alcoholism - use of more than 30 ml of ethyl alcohol per day within the last 6 months; drug addiction - use of any narcotic substances in any dose within the last 6 months; substance abuse - use of any psychoactive substances in any dose within the last 6 months).
- 21. Schizophrenia, schizoaffective disorder, history of bipolar disorder. 22. Tuberculosis, hepatitis B and C, HIV, syphilis, history or screening results.
- 23. Conditions after surgical operations, if less than 6 months have passed since the operation.
- 24. Therapy for cognitive impairment, balance disorders, and dizziness 21 days or less before the date of Visit 1.
- 25. Use of an irreversible MAO inhibitor within 14 days or a reversible MAO inhibitor within 1 day before Visit 1.
- 26. Therapy with the following drugs and groups of drugs: 7 days or less before screening:
- Selective serotonin reuptake inhibitors (SSRIs) and selective serotonin and noradrenaline reuptake inhibitors (SSNs);
- Betahistine preparations;
- Cytochrome P450 3A4 (CYP3A4) inhibitors and inducers: erythromycin, itraconazole, nefazodone, diltiazem, verapamil, etc;
- Cimetidine, warfarin, phenytoin, propranolol.
- Monoamine oxidase inhibitors (MAOIs):
- Do not use MAO inhibitors concomitantly or take the drug earlier than 14 days after withdrawal of an irreversible MAO inhibitor, or less than 1 day after withdrawal of a reversible MAO inhibitor.
- 27. History of malignancy, except for patients who have not had the disease within the last 5 years, patients with fully cured basal cell carcinoma of the skin, or fully cured carcinoma in situ.
- 28. Decompensated somatic diseases that, in the opinion of the investigator, would prevent the patient from following the regimen prescribed by the study protocol, or would not allow evaluation of therapy and compliance in accordance with the protocol, or could distort the results of the study.
- 29. Decompensated neuropsychiatric conditions, including multiple sclerosis, Parkinson's disease, endogenous depression or other conditions that, in the opinion of the investigator, will not permit the patient to follow the regimen prescribed by the research protocol or will not permit an evaluation of treatment effectiveness and compliance in accordance with the protocol, or may skew the results of the study.
- 30. Women who are pregnant or lactating; women planning to become pregnant within the next 2 months.
- 31. Patient using or planning to use hormonal contraception during the study 32. Patients who need concomitant therapy prohibited in this study. 33. Participation in another clinical trial within the last 3 months prior to the screening visit date.
- 34. Acute intoxication caused by alcohol, sleeping pills, analgesics, antipsychotics.
- 35. Patient's unwillingness or inability to comply with protocol procedures (in the opinion of the study physician).
- 36. Other conditions that, in the opinion of the Researcher, prevent the patient from being included in the study.
- 37. Patient is diagnosed with COVID-19 disease at the time of screening; or has symptoms of SARS or COVID-19 within 14 days prior to screening and has a positive rapid test for COVID-19 at screening.
- Withdrawal Criteria:
- Patient's desire to stop participating in the study.
- Researcher's decision that continued participation in the study is contrary to the patient's best interests.
- Patient's inclusion in the study in violation of the inclusion and non-inclusion criteria.
- Researcher's decision to exclude the patient from the study because the patient did not cooperate adequately with the researcher during the study.
- Skipping 3 or more consecutive study drug/placebo tablets or skipping 6 or more study drug/placebo tablets.
- Unwanted event requiring withdrawal of study therapy or limiting protocol procedures.
- Need to prescribe a patient medication from the Prohibited Companion Therapies section.
- Loss of communication with the patient.
- Pregnancy of the patient.
- For each research visit: patient diagnosed with COVID-19 disease at the time of the visit; or presence of symptoms of ARI or COVID-19 within 7 days prior to the research visit and a positive rapid test for COVID-19 at the research visit.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Russia8 sites
Regional budgetary health care institution "Ivanovo Regional Clinical Hospital"
Saint Petersburg, 152040
Limited Liability Company "Research Center Eco-Security"
Saint Petersburg, 191119
Limited Liability Company "X7 Clinical Research"
Saint Petersburg, 194156
Limited Liability Company "Research Center Eco-Safety"
Saint Petersburg, 196143
Limited Liability Company "MK-Med"
Saint Petersburg, 197372
Saint Petersburg State Budgetary Institution of Healthcare "City Hospital No. 40 of Kurortny District"
Saint Petersburg, 197706
St. Petersburg State Budgetary Health Institution "City Polyclinic No. 106"
Saint Petersburg, 198328
Limited Liability Company "MART"
Saint Petersburg, 199178
About this study
Official title: Double-blind Placebo-controlled Multicenter Randomized Clinical Trial to Evaluate the Efficacy and Safety of Buspirone, Sustained-release Tablets, 15 mg (JSC Valenta Pharm, Russia) in Patients With Autonomic Dysfunction Syndrome Accompanied by Vertigo
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
- Being tested
- Buspirone, Placebo
- Medical subject headings
- Vertigo, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuspironeDrug
1 tablet (15 mg) once per day for 28 days
PlaceboDrug
1 placebo tablet once per day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Buspirone, sustained-release tablets, 15 mg | Experimental | 15 mg/day Receives: Drug: Buspirone |
| Placebo | Placebo comparator | 1 placebo tablet/day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Visit 5 (day 28±1)
Secondary outcomes (9)
Frequency of response to therapy at Visits 2, 3, and 4.
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
Measured: 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.
Total Dizziness Handicap Inventory (DHI) score (25-item self-report questionnaire with total score from 0 to 100; higher scores mean a worse outcome)
Measured: 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
The difference between 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) on Visit 2-5 and Visit 1
Measured: 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
A number (%) of patients with reduction of ≥30% 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
Measured: 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
Time (days) elapsed before a ≥50% decrease in Dizziness Handicap Inventory (DHI) score (25-item self-report questionnaire with total score from 0 to 100; higher scores mean a worse outcome)
Measured: Day 1 - Day 28±1
Time elapsed before the total DHI score decreased by 30% or more from baseline
Time (days) elapsed before a ≥30% decrease in Dizziness Handicap Inventory (DHI) score (25-item self-report questionnaire with total score from 0 to 100; higher scores mean a worse outcome)
Measured: Day 1 - Day 28±1
Change in digital rating scale (DRS) score from Visit 1 to Visits 2, 3, 4, 5
The difference between the total DRS score (from minimum of 0 to maximum of 10 points; higher scores mean a worse outcome) on Visit 2-5 and Visit 1
Measured: Visit 2 (day 7±1), Visit 3 (day 14±1), Visit 4 (day 21±1), Visit 5 (day 28±1)
Ddigital rating scale (DRS) score on Visit 2, 3, 4, and 5
DRS score (from minimum of 0 to maximum of 10 points; higher scores mean a worse outcome) on the Visit
Measured: Visit 2 (day 7±1), Visit 3 (day 14±1), Visit 4 (day 21±1), Visit 5 (day 28±1)
The response on the Likert scale at Visits 2, 3, 4, and 5
Percentage of patients with complete response, significant relief, moderate relief, minor relief, and no response on the Likert scale at Visits 2, 3, 4, and 5.
Measured: Visit 2 (day 7±1), Visit 3 (day 14±1), Visit 4 (day 21±1), Visit 5 (day 28±1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start28 Jan 2022
- Primary completion9 May 2022
- Study completion9 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VertigoStudies of the same condition, open and under way.
- More trials run by Valenta Pharm JSCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valenta Pharm JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430217
- Sponsor's protocol ID
- BUSP-03-03-2021
- Status last verified
- Jun 2022
- First submitted
- 14 Jun 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Placebo-controlled Multicenter Randomized Clinical Trial to Evaluate the Efficacy and Safety of Buspirone, Sustained-release Tablets, 15 mg (JSC Valenta Pharm, Russia) in Patients With Autonomic Dysfunction Syndrome Accompanied by Vertigo
- ClinicalTrials.gov ID
- NCT05430217
- Acronym / sponsor ID
- BUSP-03-03-2021
- Conditions
- Vertigo, Autonomic Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Valenta Pharm JSCIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2022 (actual)
- Primary completion
- 9 May 2022 (actual)
- Study completion
- 9 May 2022 (actual)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to evaluate the efficacy and safety of Buspirone, sustained-release tablets, 15 mg in patients with autonomic dysfunction syndrome accompanied by vertigo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buspirone, sustained-release tablets, 15 mg | Experimental | Drug: Buspirone15 mg/day |
| Placebo | Placebo comparator | Drug: Placebo1 placebo tablet/day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (48 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buspirone1 tablet (15 mg) once per day for 28 days | Drug | Buspirone, sustained-release tablets, 15 mg |
| Placebo1 placebo tablet once per day for 28 days | Drug | Placebo |
Primary outcome
Frequency of response to therapy at Visit 5
Time frame: Visit 5 (day 28±1)
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
9 secondary outcomes
Frequency of response to therapy at Visits 2, 3, and 4.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 1 - Day 28±1
Time elapsed before the total DHI score decreased by 30% or more from baseline
Time frame: Day 1 - Day 28±1
Change in digital rating scale (DRS) score from Visit 1 to Visits 2, 3, 4, 5
Time frame: Visit 2 (day 7±1), Visit 3 (day 14±1), Visit 4 (day 21±1), Visit 5 (day 28±1)
Ddigital rating scale (DRS) score on Visit 2, 3, 4, and 5
Time frame: Visit 2 (day 7±1), Visit 3 (day 14±1), Visit 4 (day 21±1), Visit 5 (day 28±1)
The response on the Likert scale at Visits 2, 3, 4, and 5
Time frame: Visit 2 (day 7±1), Visit 3 (day 14±1), Visit 4 (day 21±1), Visit 5 (day 28±1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Buspirone in people with Vertigo and Autonomic Dysfunction, run by Valenta Pharm JSC at 8 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 48 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of response to therapy at Visit 5 (time frame: Visit 5 (day 28±1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.