Not Yet RecruitingPhase 4

IVIG in Painful Sensory Neuropathy

20 participantsStarted 2024-02

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Pain intensity the second week

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

Trial details

NCT IDNCT06183008

SponsorSorlandet Hospital HF

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2028-12

Contact for this trial

Ørnes

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

View on ClinicalTrials.gov More Sensory Neuropathy trials