-Peripheral neuropathy clinically defined: *Pure sensitive (lymph node disease) or sensorimotor neuropathies *Proved EMG, -Primary Sjögren's syndrome defined as per the European and American criteria
Conditions
Brief summary
Improvement of at least 20% over placebo in one of the following 2 scales, 3 weeks after the last treatment course (week 11): - Objective neurological criterion using the R-ODS scale (Rasch-built Overall Disability Scale) - Numerical Pain Scale (0 to 10)
Detailed description
1) Primary Sjögren's Syndrome Criteria o Quality of life scale (SF 36) o HAD depression score o Numerical Fatigue Scale : score between 0 and 10 o A fatigue scale (EMIF) : o Numerical Dry mouth Scale : score between 0 and 10 o Numerical Dry eye Scale : score between 0 and 10 o Flow of saliva (non stimulated o ESSPRI (Eular Sjogren's Syndrome Patient Reported Index) o ESSDAI (Eular Sjögren Syndrome Disease Activity index), 2) Neurological criteria o Overall Neuropathy Limitations Scale (ONLS), 3) Adverse reactions rate
Interventions
Sponsors
Eligibility
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1) Primary Sjögren's Syndrome Criteria o Quality of life scale (SF 36) o HAD depression score o Numerical Fatigue Scale : score between 0 and 10 o A fatigue scale (EMIF) : o Numerical Dry mouth Scale : score between 0 and 10 o Numerical Dry eye Scale : score between 0 and 10 o Flow of saliva (non stimulated o ESSPRI (Eular Sjogren's Syndrome Patient Reported Index) o ESSDAI (Eular Sjögren Syndrome Disease Activity index), 2) Neurological criteria o Overall Neuropathy Limitations Scale (ONLS), 3) Adverse reactions rate | — |
Primary
| Measure | Time frame |
|---|---|
| Improvement of at least 20% over placebo in one of the following 2 scales, 3 weeks after the last treatment course (week 11): - Objective neurological criterion using the R-ODS scale (Rasch-built Overall Disability Scale) - Numerical Pain Scale (0 to 10) | — |
Countries
France