A single center, randomized, open-label, comparative study to assess efficacy and safety of piracetam 4.8g/d administered for 6 months as adjuvant to standard vestibular rehabilitation (VR) therapy utilizing Cooksey Cawthorne exercises to adults suffering from moderate to severe vertigo of peripheral origin lasting for at least 3 months.

• Conditions: moderate to severe vertigo of peripheral origin

• Registration Number: EUCTR2005-005460-80-GR
• Lead Sponsor: /A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified