Vertigo Ear, Nose and Throat Other peripheral vertigo
Conditions
Interventions
2x120 mg Ginkgo biloba extract EGb 761® or 2x16 mg betahistine per day for 12 weeks
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of vertiginous syndrome not otherwise specified (ICD-10, H 81.9) or peripheral vertigo not otherwise specified (ICD-10, H81.3). (This excludes specific disorders of vestibular function such as Ménière's disease, benign paroxysmal vertigo, vestibular neuronitis, Lermoyez syndrome and central positional nystagmus as well as acute dysfunction of the inner ear) 2. Symptoms of vertigo for at least 3 months 3. At least moderate severity of vertigo, i.e. a score of = 3 on the Numeric Analogue Scale (NAS) at screening 4. Male or female outpatients aged = 45 years 5. Signed Informed consent in accordance with the legal requirements 6. Sufficient language skills, readiness and ability on the part of the patient to comply with the physician?s instructions, respond to all interview questions, and to fill in the self-assessment scales without evident difficulties and without the assistance of an interpreter 7. Negative pregnancy test at screening visit in females of childbearing potential (non-childbearing potential is defined as post-menopause for at least one year or surgical sterilization or hysterectomy at least three months before study start) 8. Use of adequate contraception by female with childbearing potential (hormonal: oral, implants, hormonal intrauterine contraceptive device (IUCD); or intrauterine contraception devices)
Exclusion criteria
Exclusion criteria: 1. Participation in another experimental drug trial at the same time or within the past 12 weeks before enrolment 2. Treament in the last 12 weeks with Ginkgo-biloba preparations or in the last 8 weeks with any cerebral blood circulation enhancing medications or antiemetics, anti-vertigo agents or antidementia drugs 3. More than 2 years present therapy-resistant vertigo 4. Morbus Ménière or Lermoyez syndrome 5. Current hospitalization of the patient 6. Contraindication for the treatment with betahistine: pheochromocytoma or bronchial asthma 7. History or evidence of alcohol and/or substance abuse or dependence within the last 5 years 8. Unacceptability to discontinue or likelihood to need medication during the study that is prohibited as concomitant treatment. The following medication is not allowed during the study: 8.1. Any psychotropic drugs including CNS stimulants, tranquilizers / hypnotics (e.g. benzodiazepines, non-benzodiazepine tranquilizers/anyiolytics like zopiclone or zolpidem, barbiturates), neuroleptics / antipsychotics, antidepressants, antiepileptics, antihistaminics and nootropics 8.2. Treatments for neuro-degenerative diseases (e. g. tacrine, donepezil, rivastigmin, metrifonate, galanthamin or any other cholinesterase inhibitor or cholinergic agonist, N-Methyl-D-Aspartate (NMDA)-antagonists (e.g. memantine), nimodipine, vasodilators and haemorheological agents with cerebral activity (e. g. bencyclane, buflomedil, hydergine), other cognition enhancers (e. g. piracetam) 8.3. Anticholinergic and anti-Parkinson drugs (e.g. oxybutynin, tolterodine, trospium chloride, propiverin, l-dopa, selegilin, amantadine, biperiden, benzatropin, metixen etc) 8.4. Anticonvulsants (carbamazepin, phenytoin) 8.5. Antiemetics, anti-vertigo agents 8.6. Aminoglycoside antibiotics 8.7. Long-term therapy with salycilates (> 100mg per day) 8.8. Loop diuretics: furosemide, bumetanide 8.9. Antineoplastics (cisplatin, carboplatin) 8.10. Quinine 9. Clinically significant abnormality of ECG and/or laboratory value(s) 10. Severe, uncontrolled cardiovascular disease, especially: 10.1. Severe (stage IV acc. to the Canadian Cardiovascular Society) or unstable angina pectoris 10.2. Decompensated congestive heart failure [New York Heart Association (NYHA) stage IV] 10.3. Myocardial infarction within the last 6 months 10.4. Uncontrolled hypertension (systolic pressure >180 mmHg, diastolic pressure >115 mmHg) 10.5. Known clinically significant cardiac arrhythmias 10.6. Atrial fibrillation with known or suspected left ventricular myocardial dysfunction. 11. Any severe 11.1. Hepatic, renal disorders [serum creatinine or serum aspartate amino transferase (ASAT), alanine amino transferase (ALAT) or Gamma-glytamyl transpeptidase (Gamma GT)] above 3 times the upper limit of the reference range 11.2. Insulin dependent diabetes mellitus 11.3. Respiratory diseases 11.4. Metabolic disorder or progressive diseases, such as cancer (exception: prostate cancer T1N0M0 which does not require treatment within the next 7 months except hormone therapy) 11.5. Haematologic diseases 11.6. Neurological diseases (epilepsy or a history of seizure disorder or treatment with anticonvulsants for epilepsy or seizures, Parkinson?s disease, multiple sclerosis, injury with residual neurologic deficits) 12. Severe head trauma, brain tumor, apoplexy 13. Neuritis vestibularis, herpes zoster oticus 14. Vertigo due to specific somatic diseases, e.g. orthostatic hypotension, hypertension, hemat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. 11-point Numeric Analogue Scale (NAS), measurement of subjectively perceived severity of vertigo 2. Short form of the Vertigo Symptom Scale (VSS-SF), subjectively perceived severity of vertigo symptoms 3. Sheehan Disability Scale (SDS), assessment of the impairment of daily living 4. Clinical Global Impression (CGI), physician rated, for changes from baseline as well as as for the assessment of the tolerability Measured at screening, baseline (Day 0), Week 4, Week 8 and the final visit Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Physical examination 2. Neuro-otological examination 3. Electrocardiogram (ECG) 4. Vital signs 5. Adverse events 5. Laboratory tests Measured at baseline and end of trial | — |
Countries
Ukraine
Outcome results
None listed