painful diabetic polyneuropathy resistant to conventional therapies MedDRA version: 14.1 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: FLEBOGAMMA DIF
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN
CAS Number: NA
Current Sponsor code: NA
Other descriptive name: NA
Concentration
Sponsors
AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA' GRANDA (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients males and females, age> 18 years; Outpatients; Diagnosis of painful diabetic polyneuropathy for at least 6 months up to a maximum of 5 years, confirmed according to the criteria of the Expert Group Toronto Diabetic Neuropathy; intensity of pain > 60 units in the visual-analogue scale (VAS) at baseline; DN4 questionnaire to score = 4; Prior treatment with NSAIDs, tricyclic antidepressants and anticonvulsants, and unsatisfactory results despite the achievement of therapeutic doses (pain reduction less than 30% to rating scale) or who have failed to take prescribed treatments for intolerable side effects, patients who have given written informed consent. Second phase of inclusion: Average pain assessment = 60 mm in the VAS during the 7 days after baseline. At least 50% of the diary must be completed to assess the patient's inclusion in the study. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Any condition that, in the opinion of the investigator, may affect the patient's participation in the study, presence of other types of pain that may confound the assessment of painful polyneuropathy, patients treated with IVIg for six months at study Patients with Serum IgA 60 mm in the VAS during the 7 days after baseline. At least 50% of the diary must be completed to assess the patient's inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of IVIg in reducing the intensity of neuropathic pain in a population of patients with painful diabetic polyneuropathy resistant to conventional treatments;Secondary Objective: To evaluate the tolerability of IVIg in patients under study and changes in Quality of Life;Primary end point(s): Evaluate the intensity of pain measured by VAS scale and reported in the patient diary. Will be compared to the last seven days prior to Visit 4 with values ??reported in the patient diary VAS before treatment.;Timepoint(s) of evaluation of this end point: The primary efficacy endpoint of the study is at least 50% reduction in pain compared to baseline values ??between patients treated with IVIg compared with a reduction of 25% in the placebo group. These changes in pain relief will be assessed by the average of the last 7 in the VAS values ??reported in the patient diary prior to V4 than the average VAS values ??recorded before treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluate the intensity of pain measured by VAS scale is the diary that assessed the value of VAS at the time of the visit, the quality of life measured by SF36 questionnaire, and the type of pain NPSI identified with the questionnaire and the clinical global is expressed by the physician through the CGI-C scale only by the patient through the PGI-C.;Timepoint(s) of evaluation of this end point: The VAS scale for assessing pain reduction by comparing the average of VAS values ??reported in the patient diary every week and after the end of treatment than the average VAS values ??recorded before treatment. The VAS scale for the assessment of pain relief assessed by comparison of VAS values ??at each visit with the value measured immediately before treatment VAS ? The SF-36 questionnaire for assessing quality of life of patients by comparing the values ??obtained each visit with the value recorded immediately before treatment. The NPSI questionnaire for assessing the type of pain by comparing the values ??obtained at each visit with the value recorded immediately before treatment. | — |
Countries
Italy
Contacts
Public ContactDIPARTIMENTO DI NEUROSCIENZE
A.O. NIGUARDA CA' GRANDA
Outcome results
None listed