IVIG in Painful Sensory Neuropathy

NCT06183008 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: IVIGSeN
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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 without a known cause. Effect of the treatment will be recorded by the patient in a digital diary.

Conditions

Sensory Neuropathy; Small Fiber Neuropathy

Keywords

nervous system diseases; neuromuscular diseases; peripheral nervous system diseases; small fiber neuropathy; sensory neuronopathy; sensory neuropathy; IVIG; Intravenous immunoglobulin; n-of-1; Sørlandet sykehus; Sorlandet hospital; Kristiansand; polyneuropathy; Intravenous immune globulin

Outcome Measures

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

  The second week after start of IVIG/Placebo infusions (mean of days 8, 10 and 13)

Secondary Outcomes (4)

• Pain intensity across 4 weeks

  Day 8 to 34 after start of each infusion

• Disability and quality of life

  At the end of the third week after infusion

• Anti-FGF3 antibodies

  Before start of infusion of IVIG/Placebo week 1, 5, 11, 16, 21 and 26

• Adverse events

  From start to end of interventions week 1 - 30

Study Arms (2)

Intravenous Immunoglobulin

EXPERIMENTAL

3 courses Intravenous immunoglobulin, Infusion solution, 100mg/ml, 2g/kg over 3 days

Drug: Intravenous immunoglobulin

Placebo

PLACEBO COMPARATOR

3 courses Saline infusion solution 0,9%, same volume as IVIG over 3 days

Drug: Placebo

Interventions

Intravenous immunoglobulin DRUG

Each patient will during the 30-week trial period get 3 IVIG courses (each total dose 2g/kg) for three consecutive days

Also known as: IVIG, Privigen

Intravenous Immunoglobulin

Placebo DRUG

Each patient will during the 30-week trial period get 3 placebo courses (each 0.9% saline similar volume) for three consecutive days

Also known as: 0.9% saline

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sorlandet Hospital HF: lead
• Oslo University Hospital: collaborator
• University Hospital of North Norway: collaborator
• University Hospital of Saint-Etienne: collaborator

MeSH Terms

Conditions

Small Fiber Neuropathy; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Polyneuropathies

Interventions

Immunoglobulins, Intravenous; Saline Solution

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jon-Marius Ørnes, Cand.med

  Sorlandet Hospital HF, Department of Neurology

  PRINCIPAL INVESTIGATOR

• Unn Ljøstad, Cand.med PhD

  Sorlandet Hospital HF, Department of Neurology

  STUDY DIRECTOR

• Åse Mygland, Cand.med PhD

  Sorlandet Hospital HF, Department of Neurology

  STUDY DIRECTOR

Central Study Contacts

Ørnes

CONTACT

+47 38125396; Jon-Marius.Rognhaug.Ornes@sshf.no

Unn Ljøstad

CONTACT

+47 38073908; Unn.Ljostad@sshf.no

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: N-of-one trial, individual randomized, double-blind, and multiple crossover comparisons of an interventional treatment and placebo

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 27, 2023
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 27, 2023

Record last verified: 2023-03