IVIG in Painful Sensory Neuropathy
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSorlandet Hospital HF
About this trial
The goal of this clinical trial is to assess effect of Intravenous immunoglobulins (antibodies) as compared to Placebo, on pain intensity in patients from 18-65 years with painful sensory neuropathy without a known cause. Effect of the treatment will be recorded by the patient in a digital diary.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Idiopathic small fiber neuropathy (all of the following)
Neuropathic pain (length-dependent/non-length dependent/focal) and at least two of the following clinical signs
Hypoesthesia (tactile, pinprick, or thermal)
Allodynia (tactile, dynamic, thermal, pressure)
Disqualifiers
Previous allergic reaction to IVIG or other blood products)
Selective IgA deficiency
Cardiac insufficiency (NYHA III/IV ie marked or severe limitation in activity due to symptoms, even during less-than-ordinary activity)
Cardiac dysrhythmia requiring treatment
Trial design
Design model
Crossover
Treatments tested in this trial
Intravenous immunoglobulin
DrugEach patient will during the 30-week trial period get 3 IVIG courses (each total dose 2g/kg) for three consecutive days
Placebo
DrugEach patient will during the 30-week trial period get 3 placebo courses (each 0.9% saline similar volume) for three consecutive days
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Intravenous ImmunoglobulinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain intensity the second week
Pain intensity after IVIG/Placebo infusions scored on a numeric rating scale (NRS) ranging from 0 to 10
Time frame
The second week after start of IVIG/Placebo infusions (mean of days 8, 10 and 13)Secondary outcomes
1
Pain intensity across 4 weeks
Pain intensity across 4 weeks after start of each infusion (mean of scoring three times per week from)
Time frame
Day 8 to 34 after start of each infusion2
Disability and quality of life
Scored on: Polyneuropathy Patient-reported Index (CAPPRI)
Time frame
At the end of the third week after infusion3
Anti-FGF3 antibodies
Blood samples will be tested for anti-FGF3 antibodies to evaluate their association with the observed clinical response in terms of pain relief to IVIG.
Time frame
Before start of infusion of IVIG/Placebo week 1, 5, 11, 16, 21 and 264
Adverse events
Recording adverse events
Time frame
From start to end of interventions week 1 - 30Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sorlandet Hospital HF
Lead sponsor
Oslo University Hospital
Collaborator
University Hospital of North Norway
Collaborator
University Hospital of Saint-Etienne
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: