Actively Recruiting
Open-label, Randomized Trial of Vespireit Prolonged-release Tablets Versus Arlevert Tablets in Adults With Autonomic Dysfunction Syndrome and Functional Vertigo
Led by Valenta Pharm JSC · Updated on 2025-06-15
160
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of Vespireit prolonged-release tablets compared to Arlevert tablets in adults aged 18 to 65 with autonomic dysfunction syndrome accompanied by functional vertigo. This phase 4, open-label, randomized controlled trial investigates how these treatments impact symptoms related to vertigo and autonomic dysfunction. Participants will be randomly assigned to receive either Vespireit, 15 mg once daily in the morning with food, or Arlevert, 40 mg plus 20 mg three times daily with food. Both treatments are taken orally as whole tablets for 28 days. The study includes an initial treatment phase and a retreatment period, with careful monitoring throughout. During the study, participants will have multiple visits to assess changes in vertigo symptoms using the Mean Vertigo Score and Dizziness Handicap Inventory, as well as quality of life and anxiety levels. Researchers will track adverse events and therapy effectiveness through patient and physician evaluations. The study duration includes the initial 28-day treatment with follow-up visits extending through a retreatment period lasting up to 42 days.
CONDITIONS
Brief Title
Efficacy and Safety of Vespireit, Prolonged-release Tablets, in Patients With Autonomic Dysfunction Syndrome Accompanied by Functional Vertigo
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient signed and dated the Informed Consent Form.
- Male or female aged 18 to 65 years at consent.
- Clinical diagnosis of autonomic nervous system disorder (G90.8 or G90.9).
- Diagnosed chronic functional vertigo with a total DHI score of 31 or higher and mean MVS score of 1.5 or higher.
- Women of childbearing potential must have a negative pregnancy test and agree to authorized contraception during the study and for 3 weeks after.
- Men must agree to use authorized contraception during the study and for 3 weeks after.
- Postmenopausal women or surgically sterile women and men with documented infertility or vasectomy are also eligible.
You will not qualify if you...
- Known or suspected allergy to study drugs or their ingredients.
- Lactose intolerance or related digestive disorders.
- High suicide risk (score > 2 on Suicide Risk Assessment Scale).
- Severe heart failure (NYHA class III-IV) or severe angina.
- Uncompensated vestibular disorders or recent exacerbation of vestibular diseases.
- Meniere's disease or bilateral vestibular insufficiency.
- Syncope or presyncope at screening.
- Recent acute cardiovascular events or surgeries within 6 months.
- Significant heart rhythm or conduction problems, pacemaker.
- Liver failure or abnormal liver tests.
- Kidney failure or low creatinine clearance.
- Pyloroduodenal obstruction, prostatic hyperplasia, thyroid disorders.
- Parkinson's disease, severe ischemic heart disease.
- Uncontrolled high or low blood pressure.
- Uncontrolled diabetes.
- Myasthenia gravis.
- Closed-angle glaucoma or suspected high eye pressure.
- Autoimmune or connective tissue diseases.
- History or suspicion of elevated intracranial pressure.
- Urinary retention due to prostate or urethral disease.
- Planned surgery or endovascular treatment in next 15 months.
- Epilepsy or seizures.
- Recent history of substance abuse or dependence.
- History of serious psychiatric disorders.
- Infectious diseases like tuberculosis, hepatitis B or C, HIV, syphilis.
- Recent surgery within 6 months.
- Recent therapy for cognitive or balance disorders within 21 days.
- Recent use of certain medications including SSRIs, cinnarizine, dimenhydrinate, MAO inhibitors.
- History of cancer except certain cured skin cancers.
- Decompensated somatic or neuropsychiatric diseases affecting study compliance.
- Pregnancy, breastfeeding, or planning pregnancy within 15 months.
- Use of prohibited medications.
- Participation in another clinical trial within last 3 months.
- Unwillingness or inability to comply with study procedures.
- Current or recent COVID-19 infection or symptoms.
- Decision to discontinue participation or investigator's judgment.
- Poor cooperation or communication.
- Missed study drug doses beyond allowed limits.
- Adverse events requiring withdrawal.
- Ineffective therapy based on symptom scores.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants receive either Vespireit or Arlevert tablets for autonomic dysfunction syndrome accompanied by functional vertigo.
3 visits during the initial 28-day treatment period
Duration - 42 days
Participants may receive additional treatment during the retreatment period to manage symptoms.
4 visits during the 42-day retreatment period
Duration - From Day 1 to end of study
Participants are monitored for disease exacerbation, remission duration, and safety outcomes after treatment.
Visits occur at the end of study participation as scheduled
Trial Site Locations
Total: 4 locations
1
Central Clinic LLC
Bryansk, Russia, 241050
Actively Recruiting
2
Federal State Budgetary Educational Institution of Higher Education "Kirov State Medical University" of the Ministry of Healthcare of the Russian Federation
Kirov, Russia, 610027
Actively Recruiting
3
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, Russia, 109263
Actively Recruiting
4
Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of the city of Smolensk"
Smolensk, Russia, 214025
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here