Painful Neuropathies MedDRA version: 9.1 Level: PT Classification code 10012680 Term: Diabetic neuropathy
Conditions
Interventions
Trade Name: FLEBOGAMMA 5%
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Immunoglobulins, normal human, for intravascular adm.
Concentration unit: g/l gram(s)/litre
Concentration type
Sponsors
AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA' GRANDA (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with painful neuropathy treatment resistent 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: Patients with psychiatric disorders, or with other kinds of pain (not neuropathic)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy of IVIg in treatment resistent painful neuropathies;Secondary Objective: To evaluate tollerability of IVIg;Primary end point(s): pain intensity evaluated using VAS | — |
Countries
Italy
Outcome results
None listed