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RecruitingNCT06321341Updated Jun 15, 2025

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

A Phase 4 interventional study of Vespireit and Arlevert in Vertigo and Autonomic Dysfunction, sponsored by Valenta Pharm JSC. Recruiting at 4 sites in Russian Federation. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-06-15.

Sponsored by Valenta Pharm JSC · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 9 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Vertigo
  • Autonomic Dysfunction

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03

In context

Vertigo

187 studies on the registry are indexed under Vertigo; 27 are open to participants now.

This study's planned enrollment of 160 is above the median of 73 across 138 interventional studies indexed under Vertigo.

Browse Vertigo studies →

Lead sponsor

Valenta Pharm JSC is the lead sponsor of 40 studies on the registry; 18 are open to participants now.

Browse Valenta Pharm JSC studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patient signed and dated the Form.
  2. Males and females ≥18 to ≤ 65 years of age inclusive at the time of signing the Informed Consent Form.
  3. Clinical diagnosis: G90.8 Other disorders of autonomic nervous system or G90.9 Disorder of autonomic nervous system, unspecified.
  4. Diagnosed chronic functional vertigo per Barani Society criteria: total DHI score ≥ 31 points; mean MVS score ≥ 1.5 points.
  5. For women of , a negative pregnancy test and consent to use an authorized method of throughout the entire period of study participation, starting from Visit 0, and for 3 weeks after the end of the study; for men, consent to use an authorized method of contraception throughout the entire period of study participation and for 3 weeks after the end of the study.

The authorized contraceptive methods in this study are: intrauterine device, barrier method, or dual barrier method (condom or occlusive cap (diaphragm or cervical/vaginal cap) plus spermicide)). Hormonal contraception was not permitted due to insufficient data on drug interactions of buspirone.

women (≥2 years of amenorrhea) or women who are surgically sterile (hysterectomy, bilateral ovariectomy, tubal ligation)) and men with documented infertility or vasectomy will also be eligible for the study.

Non-inclusion Criteria:

  1. Known or suspected to the active substance or any of the of the drugs.
  2. Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
  3. A cumulative score > 2 on the Suicide Risk Assessment Scale (SRAS).
  4. Chronic heart failure III-IV functional classes according to the (NYHA) classification, angina pectoris III-IV functional classes.
  5. Presence of uncompensated peripheral vestibular hyporeflexia due to previous vestibular neuronitis, labyrinthitis, labyrinth trauma.
  6. Presence at the time of screening of exacerbation of vestibular diseases with episodic vestibular syndrome.
  7. Meniere's disease.
  8. Established diagnosis of bilateral vestibular insufficiency.
  9. Syncopal and presyncopal conditions at the time of screening.
  10. Acute cardiovascular disease or surgical interventions (myocardial infarction, angioplasty, aortocoronary/mammary coronary heart bypass, unstable angina, and others) less than 6 months prior to the date of the Screening Visit.
  11. Acute cerebral circulatory disorders and/or less than 6 months prior to the date of the Screening Visit.
  12. Hemodynamically significant cardiac rhythm and conduction abnormalities, including a history of cardiac rhythm and conduction abnormalities.
  13. An installed artificial pacemaker.
  14. abnormalities;
  15. Established diagnosis of liver failure, including history and/or altered laboratory values: increase in aspartateaminotransferase (), alanineaminotransferase (ALT) more than 2.5 times relative to the , increase in total more than 1.5 times above the upper limit of normal;
  16. Established diagnosis of renal failure of any severity and/or calculated by the Cockcroft-Gault formula at screening \< 80 ml/min in women and \< 90 ml/min in men.
  17. Pyloroduodenal obstruction based on history.
  18. Prostatic hyperplasia.
  19. Thyroid function disorder according to examination and clinical and laboratory tests.
  20. Parkinson's disease according to anamnesis.
  21. Severe ischemic heart disease.
  22. Uncontrolled hypertension with systolic blood pressure > 180 mm Hg and/or diastolic blood pressure > 110 mm Hg, or blood pressure (BP) at screening ≥140/90 or ≤ 100/60 mm Hg.
  23. Uncontrolled diabetes mellitus, diabetes mellitus in decompensation.
  24. Myasthenia gravis.
  25. Closed-angle glaucoma.
  26. Suspicion of elevated intraocular pressure at the time of screening.
  27. Systemic connective tissue diseases.
  28. diseases.
  29. History or suspected elevated intracranial pressure.
  30. Urinary retention due to a history of urethral and/or prostate disease.
  31. Need for surgical and/or endovascular treatment in the next 15 months.
  32. Epilepsy or convulsive seizures, including history of seizures.
  33. Alcoholism, drug dependence, substance abuse in the history and/or at the time of screening (alcoholism - use of more than 30 ml of ethyl alcohol per day during the last 6 months; drug dependence - use of any narcotic substances in any doses during the last 6 months; substance abuse - use of any psychoactive substances in any doses during the last 6 months).
  34. History of schizophrenia, schizoaffective disorder, bipolar disorder.
  35. Tuberculosis, and C, infection, syphilis, history or by screening.
  36. Conditions after surgical procedures, if less than 6 months have passed since the intervention.
  37. Therapy for cognitive impairment, balance disorders, and dizziness 21 days or less prior to Visit 1-1 date.
  38. Use of an irreversible MAO inhibitor within 14 days or a reversible MAO inhibitor within 1 day prior to Visit 1-1.
  39. Therapy with the following drugs and drug groups: 7 days or less before screening: Selective serotonin reuptake inhibitors (SSRIs) and selective serotonin and norepinephrine reuptake inhibitors (SSRIs); Cinnarizine and/or dimenhydrinate preparations; Cytochrome P450 3A4 (Cytochrome P450 3A4, ) inhibitors and inducers: Erythromycin, itraconazole, nefazodone, diltiazem, verapamil, etc.; Cimetidine, warfarin, phenytoin, propranolol. Monoamine oxidase inhibitors (MAOIs): concomitant use of MAO inhibitors is prohibited, as well as taking 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.
  40. Presence of a history of malignant neoplasm, except in patients who have had no disease in the past 5 years, patients with completely cured basal cell skin cancer, or completely cured carcinoma in situ.
  41. Decompensated somatic diseases that, in the opinion of the investigator, would prevent the patient from complying with the regimen prescribed by the study protocol, or would prevent assessment of the efficacy of therapy and compliance according to the protocol, or could skew the results of the study.
  42. Decompensated neuropsychiatric diseases, including multiple sclerosis, Parkinson's disease, endogenous depression, and others, which in the opinion of the investigator would prevent the patient from complying with the regimen prescribed by the study protocol, or would prevent assessment of therapy efficacy and compliance according to the protocol, or could skew the results of the study.
  43. Female patients who are pregnant or breastfeeding or planning pregnancy within the next 15 months.
  44. Patients requiring prohibited concomitant medications.
  45. Participation in another clinical trial within the last 3 months prior to the date of the Screening Visit.
  46. Patient's unwillingness or inability to comply with protocol procedures (in the opinion of the investigator).
  47. Other conditions that, in the judgment of the investigator, preclude the patient's inclusion in the study.
  48. The patient is diagnosed with COVID-19 disease at the time of screening or Randomization Visit; or the presence of symptoms of acute respiratory infections or COVID-19 within 14 days prior to screening and a positive rapid test for COVID-19 at screening.

Exclusion criteria

Exclusion criteria:

  1. The patient's decision to discontinue participation in the study.
  2. A decision by the investigator that continued participation in the study is contrary to the patient's best interests.
  3. The patient is included in the study in violation of the inclusion and non-inclusion criteria.
  4. 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.
  5. Diagnosis of acute (vestibular neuronitis, acute labyrinthitis, traumatic vestibulopathy, stroke with lesions of central and peripheral vestibular structures and others) and/or episodic vestibular syndromes (benign positional paroxysmal vertigo, Meniere's disease, vestibular migraine and others), bilateral vestibulopathy.
  6. Skipping taking the study drug (3 consecutive tablets or more than 6 tablets for each period of therapy).
  7. Omission of the active comparator (9 consecutive tablets or more than 17 tablets per therapy period).
  8. An adverse event requiring withdrawal of therapy or limiting protocol procedures.
  9. The need to prescribe to the patient drugs from the "Prohibited Concomitant Therapies" section.
  10. Loss of communication with the patient.
  11. Pregnancy.
  12. Ineffectiveness of therapy (increase from baseline or no decrease in DHI total score and MVS mean score by 25% or more from baseline after another course of therapy).
  13. The patient was diagnosed with COVID-19 disease during the periods of primary and repeated therapy.
Terms in these criteria, in plain language(19)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    Vespireit, prolonged-release tablets, 15 mg

    Dosage regimen: 1 tablet once a day at approximately the same time in the morning under fed conditions for 28 days. The drug is taken orally, whole, without breaking and not chewing.

    Drug: Vespireit

  • Active comparator
    Arlevert, tablets, 40 mg + 20 mg

    Dosage regimen: 1 tablet 3 times a day at approximately the same time under fed conditions for 28 days. The drug is taken orally, whole, without breaking and not chewing.

    Drug: Arlevert

Interventions

  • DrugVespireit

    Buspirone

  • DrugArlevert

    Dimenhydrinate + Cinnarizine

06

What researchers measure

Primary outcomes

  1. Change in Mean vertigo score (MVS) at Visit 1-3 of the Initial Treatment Phase relative to baseline at Visit 1-1

    Difference in MVS assessed on Visit 1-3 and 1-1 (12-item scale with score from 0 to 4 for each item; higher scores mean a worse outcome)

    Time frame: Day 1 - Day 28±1

Secondary outcomes

  1. Change in mean MVS score at Visit 1-2 of the Initial Treatment Phase relative to baseline at Visit 1-1.

    Assessment performed using MVS (12-item scale with score from 0 to 4 for each item; higher scores mean a worse outcome)

    Time frame: Day 1 - Day 28±1

  2. Change in mean MVS score at Visits 2-2, 2-3, and 2-4 of the Retreatment Period compared with Visit 2-1.

    Assessment performed using MVS (12-item scale with score from 0 to 4 for each item; higher scores mean a worse outcome)

    Time frame: Day 1 - Day 42 ±1 (retreatment period)

  3. 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)).

    Assessment performed using MVS (12-item scale with score from 0 to 4 for each item; higher scores mean a worse outcome)

    Time frame: Day 1 - Day 28±1

  4. Percentage of patients with a ≥50% reduction in total DHI score on Visit 1-3 of the Initial Treatment Phase relative to Visit 1-1.

    Assessment performed using DHI (25-item self-report questionnaire with total score from 0 to 100; higher scores mean a worse outcome)

    Time frame: Day 1 - Day 28±1

  5. 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.

    Assessment performed using DHI (25-item self-report questionnaire with total score from 0 to 100; higher scores mean a worse outcome)

    Time frame: Day 1 - Day 42 ±1 (retreatment period)

  6. Percentage of patients with a ≥25% reduction in total DHI score on Visit 1-3 of the Initial Treatment Phase relative to Visit 1-1.

    Assessment performed using DHI (25-item self-report questionnaire with total score from 0 to 100; higher scores mean a worse outcome)

    Time frame: Day 1 - Day 28±1

  7. 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.

    Assessment performed using DHI (25-item self-report questionnaire with total score from 0 to 100; higher scores mean a worse outcome)

    Time frame: Day 1 - Day 42 ±1 (retreatment period)

  8. Change in total score on the DHI at Visit 1-3 of the Initial Treatment Phase compared with Visit 1-1.

    Assessment performed using DHI (25-item self-report questionnaire with total score from 0 to 100; higher scores mean a worse outcome)

    Time frame: Day 1 - Day 28±1

  9. Change in total score on the DHI at Visits 2-3 and 2-4 of the Retreatment Period compared with Visit 2-1.

    Assessment performed using DHI (25-item self-report questionnaire with total score from 0 to 100; higher scores mean a worse outcome)

    Time frame: Day 1 - Day 42 ±1 (retreatment period)

  10. Change in total score on the DHI at the end-of-study visit compared to the score at Visit 1-1 in patients who completed the study according to the protocol (PP(response)).

    Assessment performed using DHI (25-item self-report questionnaire with total score from 0 to 100; higher scores mean a worse outcome)

    Time frame: Day 1 - Day 28±1

  11. Change in digital rating scalescore from Visit 1-1 to Visits 1-2 and 1-3 in the Primary Treatment Period.

    Assessment performed using digital rating scale (from minimum of 0 to maximum of 10 points; higher scores mean a worse outcome)

    Time frame: Day 1 - Day 28±1

  12. Change in digital rating scale score from Visit 2-1 to Visits 2-2, 2-3, and 2-4 in the Retreatment Period.

    Assessment performed using digital rating scale (from minimum of 0 to maximum of 10 points; higher scores mean a worse outcome)

    Time frame: Day 1 - Day 42 ±1 (retreatment period)

  13. 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 Initial Treatment Phase.

    Assessment performed using EQ-5D questionnaire (5-item self-report questionnaire with total score from 0 to 100; higher scores mean a better outcome)

    Time frame: Day 1 - Day 28±1

  14. 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.

    Assessment performed using EQ-5D questionnaire (5-item self-report questionnaire with total score from 0 to 100; higher scores mean a better outcome)

    Time frame: Day 1 - Day 42 ±1 (retreatment period)

  15. 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.

    Assessment performed using HARS (21-item scale with total score from 0 to 56; higher scores mean a worse outcome)

    Time frame: Day 1 - Day 28±1

  16. 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.

    Assessment performed using HARS (21-item scale with total score from 0 to 56; higher scores mean a worse outcome)

    Time frame: Day 1 - Day 42 ±1 (retreatment period)

  17. Change in VSS-SF total score at Visit 1-3 of the Initial Treatment Phase relative to baseline at Visit 1-1.

    Assessment performed using VSS-SF score (15-item scale with score from 0 to 4 for each item; higher scores mean a worse outcome)

    Time frame: Day 1 - Day 28±1

  18. Change in VSS-SF total score at Visits 2- 3 and 2-4 of the Retreatment Period compared with Visit 2-1.

    Assessment performed using VSS-SF score (15-item scale with score from 0 to 4 for each item; higher scores mean a worse outcome)

    Time frame: Day 1 - Day 42 ±1 (retreatment period)

  19. Change in VSS-SF total score at the end-of-study visit compared with the score at Visit 1-1 in patients who completed the study according to protocol (PP(response)).

    Assessment performed using VSS-SF score (15-item scale with score from 0 to 4 for each item; higher scores mean a worse outcome)

    Time frame: From Day 1 to the end of the study

  20. Evaluation of therapy efficacy on the CGI-i scale by the patient at Visits 1-2 and 1-3 in the Initial Treatment Phase.

    Assessment performed using CGI-i scale (scale from 0 to 7; higher scores mean a worse outcome)

    Time frame: Day 1 - Day 28±1

  21. Evaluation of therapy efficacy on the CGI-i scale by the physician at Visits 1-2 and 1-3 in the Primary Therapy Period.

    Assessment performed using CGI-i scale (scale from 0 to 7; higher scores mean a worse outcome)

    Time frame: Day 1 - Day 28±1

  22. 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.

    Assessment performed using CGI-i scale (scale from 0 to 7; higher scores mean a worse outcome)

    Time frame: Day 1 - Day 42 ±1 (retreatment period)

  23. 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.

    Assessment performed using CGI-i scale (scale from 0 to 7; higher scores mean a worse outcome)

    Time frame: Day 1 - Day 42 ±1 (retreatment period)

  24. 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)

    An exacerbation (relapse) is defined as a total DHI score ≥ 31 points

    Time frame: From Day 1 to the end of the study

  25. Duration of remission period after treatment in the Initial Treatment Phase. Remission means absence of episodes of exacerbations (relapses)

    The duration of the remission period is the time from the day of completion of primary therapy to the day of the visit confirming an exacerbation (relapse) or to the day of completion of the study (if there is no exacerbation (relapse))

    Time frame: From Day 1 to the end of the study

  26. Clinically significant abnormalities on physical and/or neurologic examination

    Number and percentage of patients with clinically significant abnormalities found during physical and/or neurologic examination

    Time frame: Day 1 - Day 28±1 (primary treatment period), Day 1 - Day 42 ±1 (retreatment period)

  27. Adverse events (AEs)

    Frequency of AEs for all treatment periods stratified by severity and frequency

    Time frame: Day 1 - Day 28±1 (primary treatment period), Day 1 - Day 42 ±1 (retreatment period)

  28. Serious adverse events (SAEs)

    Frequency of SAEs

    Time frame: Day 1 - Day 28±1 (primary treatment period), Day 1 - Day 42 ±1 (retreatment period)

  29. Adverse reactions

    Frequency of AEs and SAEs associated with the use of investigational drugs

    Time frame: Day 1 - Day 28±1 (primary treatment period), Day 1 - Day 42 ±1 (retreatment period)

  30. Рatients with at least one AE

    Proportion of patients with at least one AE registered

    Time frame: Day 1 - Day 28±1 (primary treatment period), Day 1 - Day 42 ±1 (retreatment period)

  31. Patients discontinued due to AE

    Percentage of patients who discontinued treatment due to the occurrence of AE

    Time frame: Day 1 - Day 28±1 (primary treatment period), Day 1 - Day 42 ±1 (retreatment period)

07

Study locations

4 of 4 sites recruiting
  • Central Clinic LLC
    Bryansk, 241050, Russian Federation
    Recruiting
  • Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Healthcare of the Russian Federation
    Kirov, 610027, Russian Federation
    Recruiting
  • 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"
    Moscow, 109263, Russian Federation
    Recruiting
  • Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of the city of Smolensk"
    Smolensk, 214025, Russian Federation
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2024 (actual). Primary completion is estimated for Dec 2026, 35 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 13, 2024
First posted
Mar 20, 2024
StartActual
Jan 24, 2024
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Jun 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06321341
Lead sponsor
Valenta Pharm JSC
Responsible party
Sponsor
First posted
Mar 20, 2024
Start date
Jan 24, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jun 15, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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