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IVIG in Painful Sensory Neuropathy

NCT06183008 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-12-27

No results posted yet for this study

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

Interventions

DRUG

Intravenous immunoglobulin

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Oslo University Hospital

    collaborator OTHER

  • University Hospital of North Norway

    collaborator OTHER

  • University Hospital of Saint-Etienne

    collaborator OTHER

  • Sorlandet Hospital HF

    lead OTHER_GOV

Principal Investigators

  • Jon-Marius Ørnes, Cand.med · Sorlandet Hospital HF, Department of Neurology

  • Unn Ljøstad, Cand.med PhD · Sorlandet Hospital HF, Department of Neurology

  • Åse Mygland, Cand.med PhD · Sorlandet Hospital HF, Department of Neurology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2028-12-31
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06183008 on ClinicalTrials.gov