Effect of intravenous immunoglobulins on painful sensory neuropathy evaluated by aggregated N-of-one trials

Status

Not yet recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501717-31-00

Enrollment

Registered

2022-12-09

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic painful small fiber neuropathy or sensory neuronopathy.

Brief summary

Pain intensity the second week (mean of days 8, 10 and 13) after start of IVIG/placebo infusions scored on a numeric rating scale (NRS) ranging from 0 to 10

Detailed description

Pain intensity across 4 weeks after start of each infusion (mean of scoring three times per week from day 8 to 34), Disability and quality of life at the end of the third week after infusion scored on: Polyneuropathy Patient-reported Index (CAPPRI), Anti-FGF3 antibodies, Adverse events

Interventions

DRUGNatriumklorid Fresenius Kabi 9 mg/ml infusjonsvæske

DRUGoppløsning

DRUGSaline 0.9%

DRUGPrivigen 100 mg/ml solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Pain intensity the second week (mean of days 8, 10 and 13) after start of IVIG/placebo infusions scored on a numeric rating scale (NRS) ranging from 0 to 10	—

Secondary

Measure	Time frame
Pain intensity across 4 weeks after start of each infusion (mean of scoring three times per week from day 8 to 34), Disability and quality of life at the end of the third week after infusion scored on: Polyneuropathy Patient-reported Index (CAPPRI), Anti-FGF3 antibodies, Adverse events	—

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026