moderate to severe vertigo of peripheral origin
Conditions
Interventions
Product Name: Nootrop
Pharmaceutical Form: Granules for oral solution
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age range 20-65 years, males/females 2. Diagnosis of unilateral peripheral vestibular disorder based on: • History of recurrent vertigo attacks lasting for at least 3 months • Audiometric tests showing normal hearing, and absence of VIII nerve lesion or brainstem dysfunction. • Unilateral canal paresis on standard Fitzgerald-Hallpike caloric testing as measured by the duration parameter using the Jongkees formula of >15% in the absence of optic fixation. • Direct current electonystagmography (ENG) that demonstrated no abnormality, or the presence of unidirectional spontaneous nystagmus on gaze testing with enhancement of the response on removal of optic fixation. 3. Severe vertigo cases as assessed by CGI (physician administered) severity score equal or greater than 4 or/and V.S.S. score above 25 at initial visit. 4. Giving informed consent. 5. Withdrawal from any anti-vertigo medication received prior to study initiation. 6. Absence of piracetam taking at least 1 month prior to study initiation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Presence of central vestibular disorder. 2. Progressive of fluctuating vestibular pathology such as Meniere’s syndrome, migrainous vertigo, BPPV. 3. Bilateral vestibular failure. 4. Central nervous system space occupying or degenerative diseases and any musculoskeletal, visual or psychiatric disorders. 5. Genetic hearing loss 6. Known hypersensitivity to piracetam, pyrrolidone derivatives and any of the medication form contents 7. Female patients during pregnancy and lactation 8. Medication taking including CNS acting, psychostimulants and peripheral vasoacting drugs. 9. Any blood related diseases identified. 10. Abnormal coagulation function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To ascertain whether adding piracetam to vestibular rehabilitation (VR) contributes to the improvement of abnormal neuro-otological findings including ENG at the end of the 180-day treatment period compared to baseline;Secondary Objective: To assess the contribution of adding piracetam to VR at relief of patients’ symptomatology assessed by V.S.S. (Vertigo Symptom Scale short-form) and the three subscales of the D.H.I. (Dizziness Handicap Inventory) assigned at each reassessment visit. To assess time-to-relief from vertigo symptoms by adding piracetam to VR. To compare frequency, duration and severity of vertigo relapses during the first and second 90-day treatment period in the treatment groups, as assessed by utilizing patient diaries. To assess type, incidence and severity of adverse events by adding 4,8g daily piracetam to standard VR in patients experiencing chronic vertigo of peripheral origin. ;Primary end point(s): Contribution of piracetam to the relief of the patients’ symptomatology assessed by incorporation of validated scales namely Vertigo symptoms Scale-short form -V.S.S and Dizziness Handicap Inventory -D.H.I. subscales. | — |
Countries
Greece
Outcome results
None listed