NONE MedDRA version: 9.1 Level: SOC Classification code 10013993
Conditions
Interventions
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: PSICCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
Concentration unit: mg milligram(s)
Concentration type: equal
Co
Sponsors
FONDAZIONE IRCCS OSPEDALE MAGGIORE POLICLINICO MANGIAGALLI E REGINA ELENA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: o diagnosis and start of the treatment within 72 hours from onset of the symptoms o age>18 years o patients without severe systemic disease 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: o onset of the symptoms more than 72 hours o age<18 years o claustrophobia o psychosis o acute otitis o pregnancy (first-quarter) o hypertension without therapy o epilepsy o ischemic or congestive cardiac failure o severe pulmonary disease o glaucoma o detachment of the retina o pneumothorax or emphysema o tubaric dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation the number of patients that have: oa full retrieval of hearing (return to previous or to normal auditory threshold) after the therapy oan improvement of auditory threshold (>50%) after the therapy oa failure of the therapy (<50%);Secondary Objective: None;Primary end point(s): Healing of the patients | — |
Countries
Italy
Outcome results
None listed