Study to assess the effectiveness of high doses of immunoglobulin in the treatment of polyneuropathy painful diabetic resistant to conventional therapies
- Conditions
- painful diabetic polyneuropathy resistant to conventional therapiesMedDRA version: 14.1Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2010-023883-42-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA' GRANDA (A.O. DI RILIEVO NAZIONALE)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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 <70 mg / dL; Cardiovascular disease failure, or uncontrolled by drug therapy, renal failure, liver failure, severe alterations of the Peripheral blood counts (leukopenia, thrombocytopenia, pancytopenia), psychiatric disease, amputations, pregnancy and lactation; Participation in clinical trials in the 30 days preceding the beginning of this study. Second phase inclusion Media> 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method