E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postural disturbances in the elderly |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049848 |
E.1.2 | Term | Balance disorder |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the effects of TANGANIL on postural disturbances related to vestibular disorder without vertigo in the elderly.
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E.2.2 | Secondary objectives of the trial |
- to assess the effects of TANGANIL on patient's self-perceived handicap of dizziness, - to assess the systemic tolerability of TANGANIL. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of study is the date of the last visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |