E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with cognitive and behavioural disorders following severe TBI and other severe acquired brain injury Glasgow Coma Scale GCS lower or equal 8 |
|
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 | 10057668 |
E.1.2 | Term | Cognitive disorder |
|
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 |
Evaluation of the rivastigmine tolerability in a population of young adult patients not suffering from a degenerative illness i. e. Alzheimer Disease, in which this drug is already utilized |
|
E.2.2 | Secondary objectives of the trial |
Attentional, mnesic and behavioural improvement |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Age between 18 and 55 years. Pathological performances in at least one test of the neuropsycological battery. 12 months minimum from traumatic brain injury. 12 weeks minimum between the last neuropsychological evaluation before the present study and the first experimental evaluation, in order to avoid learning effects |
|
E.4 | Principal exclusion criteria |
Severe upper limbs motor impairment which hampers the possibility of the neuropsychological evaluation Severe speech impairment which hampers the possibility of the neuropsychological evaluation Mini Mental State Examination MMSE lower than 14 Token Test score age and school corrected equal to 0 Previous traumatic brain injury Previous or in progress uncontrolled diabetes mellitus Previous or in progress chronic ostructive broncopneumopathology Delay in electric cardiac conduction Peptic ulcera in progress Positive family or personal anamnesis for glaucoma Positive personal anamnesis for alcoholism Positive personal anamnesis for drug use or abuse Uncontrolled epilepsy presence of crisis in the last 6 months Pregnancy Psychiatric pathology in Axis I of the DSM IV-R major psychiatric disorders Known cholinesterase inhibitors ipersensibility Actual assumption of anticholinergic, neuroleptics or benzodiazepine drugs Chronic post-traumatic amnesia PTA Galveston Orientation Amnesia Test lower or equal to 75 Patient inability to give his own informed consent. Pharmacologically uncontrolled severe arterious hypertention |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Effects of rivastigmine in terms of family, social and work re-entry on patient with traumatic brain injury |
|
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 | No |
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 5 |