Status:
NOT_YET_RECRUITING
IVIG in Painful Sensory Neuropathy
Lead Sponsor:
Sorlandet Hospital HF
Collaborating Sponsors:
Oslo University Hospital
University Hospital of North Norway
Conditions:
Sensory Neuropathy
Small Fiber Neuropathy
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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 w...
Detailed Description
Patients suffering from idiopathic sensory neuropathies often report excruciating pain that interferes with daily function and leads to impaired quality of life. Current neuropathic pain treatment opt...
Eligibility Criteria
Inclusion
- Painful sensory neuropathy fulfilling diagnostic criteria for idiopathic small fiber neuropathy or sensory neuronopathy
- 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)
- Hyperalgesia
- Aftersensation
- Normal nerve conduction studies:
- Reduced intra-epidermal nerve fiber density at the distal leg (IENFD) at the distal leg or Reduced thermal threshold assessed at the foot by QST
- Causal investigation according to clinical guidelines has not revealed a cause of the neuropathy
- Sensory neuronopathy (all of the following)
- Clinical pure sensory neuropathy
- A score \>6.5 on the following
- Ataxia in the lower or upper limb: 3.1p
- Asymmetrical distribution of sensory loss: 1.7p IVIGSeN Protocol number 1.2
- Sensory loss not restricted to the lower limb at full development: 2.0 p
- At least 1 sensory action potential absent or 3 sensory action potentials \<30% of the lower limit of normal in the upper limbs not explained by entrapment neuropathy: 2.8p
- Less than two nerves with abnormal motor nerve conduction studies in the lower limbs: 3.1p
- Causal investigation according to clinical guidelines has not revealed a cause of the neuropathy
- Pain intensity \> 5.0 on a pain score from 0-10, lasting at least 4 weeks
Exclusion
- Participants are excluded from the study if any of the following criteria apply:
- Medical Conditions
- 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
- Unstable or advanced ischemic heart disease
- Severe hypertension (diastolic \>120 or systolic \> 170)
- Known hyperviscosity
- Renal insufficiency (GFR \< 30 ml/min/1,73m2) or nephrotic syndrome
- Previous thromboembolic event
- Smoking
- Diabetes
- Prolonged immobilization
- Hypercoagulable state
- Prior/Concomitant Therapy
- Change of pain medication in the 30 days prior to inclusion (unchanged pain medication is allowed, provided dosages stay equal during the study)
- Treatment with IVIG the last 4 weeks or other ongoing immunomodulatory treatments
- Use of loop diuretics, Dinutuksimab beta, or Imlifidase Diagnostic assessments
- Predominant clinical or neurographic features of motor nerve fiber involvement Other Exclusions
- Females who are breastfeeding, pregnant or unwilling to practice contraception throughout the study
- Unable to give independent informed consent
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06183008
Start Date
February 1 2024
End Date
December 1 2028
Last Update
December 27 2023
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