| |
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
| | | | | | |
|
Medical History/physical examination
|
X
| | | | | | |
|
Nerve Conduction Studies
|
X
| | | | | | |
|
Skin biopsy and QST
|
X
| | | | | | |
Laboratory Assessments
(see Table 2)
|
X
|
X
|
X
|
X
|
X
|
X
| |
|
PI-NRS
|
X
| | | |
X
|
X
|
X
|
|
PGIC
| | | | |
X
|
X
|
X
|
|
SFN-SIQ
|
X
| | | |
X
|
X
|
X
|
|
NPS
|
X
| | | |
X
|
X
|
X
|
|
SFN-RODS
|
X
| | | |
X
|
X
|
X
|
|
Pain relief
| | | | |
X
|
X
|
X
|
|
Sleep quality
|
X
| | | |
X
|
X
|
X
|
|
SF-36
|
X
| | | |
X
|
X
|
X
|
|
Study Medication Infusion1
| |
X
| | |
X
| | |
|
Vital Signs2
| |
X
| | |
X
|
X
| |
|
Concomitant Medication
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
|
Adverse Events
|
X
|
X
|
X
|
X
|
X
|
X
|
X
|
- 1 Medications given over 2 consecutive days at baseline and over 1 day every 3 weeks thereafter. Treatment is allowed to be prolonged up to 4 or 2 days respectively for reasons of tolerability
- 2 Vital signs (blood pressure and heart rate) to be taken right before infusion, 30 minutes after starting infusion, and immediately after infusion completed
- 3 Visit to be conducted after completion of entire baseline infusion (Day 2, 3, or 4 depending on duration of baseline infusion)
- 4 Visit to be conducted 3-6 days after completion of the baseline infusion, not 3-5 days after baseline/Day 1 infusion began
- 5 The follow-up period will be performed by standardized telephone call interviews
- QST = quantitative sensory testing, PI-NRS = pain intensity numerical rating scale, PGIC = patients’ global impression of change, RT-SFN-SIQ = Rasch-transformed small fiber neuropathy symptoms inventory questionnaire, NPS = neuropathic pain scale, SFN-RODS = small fiber neuropathy Rasch-built overall disability outcome scale, SF-36 = short form 36 health survey
