| Screening | Treatment phase | End of Treatment | Follow-up5 | |||
---|---|---|---|---|---|---|---|
Assessment/Evaluation | - 10 days (Day -10 to Day 0) | Week 0 Baseline/ Day 1 | Completion of baseline infusion (Day 2, 3 or 4)3 | 3-6 Days after completion of baseline infusion4 | Week 3,6,9 (± 3 days) | Week 12 (± 3 days) | Month 4, 5, 6 |
Informed Consent | X | Â | Â | Â | Â | Â | Â |
Medical History/physical examination | X | Â | Â | Â | Â | Â | Â |
Nerve Conduction Studies | X | Â | Â | Â | Â | Â | Â |
Skin biopsy and QST | X | Â | Â | Â | Â | Â | Â |
Laboratory Assessments (see Table 2) | X | X | X | X | X | X |  |
PI-NRS | X | Â | Â | Â | X | X | X |
PGIC | Â | Â | Â | Â | X | X | X |
SFN-SIQ | X | Â | Â | Â | X | X | X |
NPS | X | Â | Â | Â | X | X | X |
SFN-RODS | X | Â | Â | Â | X | X | X |
Pain relief | Â | Â | Â | Â | X | X | X |
Sleep quality | X | Â | Â | Â | X | X | X |
SF-36 | X | Â | Â | Â | X | X | X |
Study Medication Infusion1 | Â | X | Â | Â | X | Â | Â |
Vital Signs2 | Â | X | Â | Â | X | X | Â |
Concomitant Medication | X | X | X | X | X | X | X |
Adverse Events | X | X | X | X | X | X | X |