Effects of TANGANIL (three 500 mg tablets twice daily) on postural disturbances in the elderly.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000562-21-FR

Enrollment

Registered

2007-07-23

Start date

2007-09-19

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postural disturbances in the elderly MedDRA version: 9.1 Level: LLT Classification code 10049848 Term: Balance disorder

Interventions

Trade Name: TANGANIL Pharmaceutical Form: Tablet INN or Proposed INN: Acetyl-D,L-leucine Current Sponsor code: L0014 CP Concentration un

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - out-patients aged over 60 years complaining of postural dusturbances, - postural disturbances reported as dizziness, dysequilibrium, unsteadiness, - postural disturbances with an abnormal Tinetti's test, - ability to perform activities of daily living independently with a Katz's index of independence in Activities of Daily Living (ADL) score at 6, - patient with a normal neurological examination, - patient with a vestibular disorder without vertigo confirmed by a caloric test and a computerized dynamic posturography, - with a nomal corrected visual acuity. 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) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Criteria related to pathologies: - genuine vertigo, ataxia, - extra-pyramidal or cerebellar disease, - mild to moderate dementia, - sequela of stroke, - foot disease interfering with balance, - locomotor disorders related to lower limb myopathy, disabling sarcopenia, osteoarthritis (hip, knee), peripheral neuropathy, - postural or postprandial hypotension, vasovagal syndrome, carotid sinus sensitivity, - chronic documented anaemia, - post-fall syndrome. Criteria related to the way of life: - heavy intake of alcohol (more than 3 glasses each day), - need for a gait aid (cane, walker). Criteria related to treatments: - sedative benzodiazepine drugs, - antidepressant drugs, - myorelaxant drugs, - neuroleptic drugs - antivertigo drugs, - patient with hypersensitivity to acetylleucine, - patient with gluten intolerance.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effects of TANGANIL on postural disturbances related to vestibular disorder without vertigo in the elderly. ; Secondary Objective: - to assess the effects of TANGANIL on patient's self-perceived handicap of dizziness, - to assess the systemic tolerability of TANGANIL. ; Primary end point(s): - Measure of subjective complaints of dizziness with a visual analogic scale, - Vestibular score during computerized dynamic posturography, - Time measure during the "timed get up and go" test, - Tinetti's score, - DHI (Dizziness Handicap Inventory) score.	—

Measure

Time frame

Main Objective: To assess the effects of TANGANIL on postural disturbances related to vestibular disorder without vertigo in the elderly. ; Secondary Objective: - to assess the effects of TANGANIL on patient's self-perceived handicap of dizziness, - to assess the systemic tolerability of TANGANIL. ; Primary end point(s): - Measure of subjective complaints of dizziness with a visual analogic scale, - Vestibular score during computerized dynamic posturography, - Time measure during the "timed get up and go" test, - Tinetti's score, - DHI (Dizziness Handicap Inventory) score.

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Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026