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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05219383
Other study ID # Chronic dysimmune neuropathy
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 2023
Est. completion date December 2026

Study information

Verified date January 2022
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Chronic dysimmune neuropathies (CDN) are a heterogenous group of acquired inflammatory demyelinating neuropathies including chronic inflammatory demyelinating polyneuropathies (CIDP), Lewis-Sumner Syndrome (LSS), multifocal motor neuropathy (MMN) and other rare entities. Despite their relatively low prevalence, CDN lead to substantial costs for patients and society. CDN are usually misdiagnosed due to progressive nature of the disease with little known data regarding disease activity and treatment response


Description:

CIDP is the most common treatable CDN worldwide. Its prevalence is ranging between approximately 1 to 8.9 cases per 100.000 . In addition, there is often the tendency to diagnose CIDP in order to attempt a treatment option. This ultimately leads to overdiagnosis and overtreatment in some patients Although the different CDN have varying underlying pathophysiology and clinical characteristics, they are all potentially treatable with immunomodulatory drugs. To date, diagnostic criteria, measurement of disease activity and treatment response of CDN are mainly based on clinical, electrophysiological, and patient related outcome parameters. The commonly used EFNS/PNS diagnostic criteria for CIDP seems to have the best sensitivity among different sets of diagnostic criteria


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 36
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Age > 18 years, both sexes, history of sensory and/or motor complaint with progressive course over more 2 months Exclusion Criteria: - *Patients with systemic diseases (DM, chronic kidney or liver disease, thyroid disease, vitamin B12 deficiency) - Family history of peripheral neuropathy or neurological symptoms suggestive for heredo-familial neurological disorders - Patients with infective cause as (HBV, HCV, HIV, leprosy) - Toxic and drug induced polyneuropathy (chemotherapeutics, antimicrobial ..

Study Design


Related Conditions & MeSH terms

  • Chronic Inflammatory Demyelinating Polyneuropathy
  • Polyneuropathies
  • Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (3)

Breiner A, Brannagan TH 3rd. Comparison of sensitivity and specificity among 15 criteria for chronic inflammatory demyelinating polyneuropathy. Muscle Nerve. 2014 Jul;50(1):40-6. doi: 10.1002/mus.24088. Epub 2013 Dec 11. — View Citation

Hartung HP, Lehmann HC, Willison HJ. Peripheral neuropathies: Establishing common clinical research standards for CIDP. Nat Rev Neurol. 2011 May;7(5):250-1. doi: 10.1038/nrneurol.2011.46. Epub 2011 Apr 12. — View Citation

Rajabally YA, Nicolas G, Piéret F, Bouche P, Van den Bergh PY. Validity of diagnostic criteria for chronic inflammatory demyelinating polyneuropathy: a multicentre European study. J Neurol Neurosurg Psychiatry. 2009 Dec;80(12):1364-8. doi: 10.1136/jnnp.2009.179358. Epub 2009 Jul 20. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients diagnosed with chronic inflammatory demyleinating polyneuropathy attending neuropsychiatry department Assiut university Number of patients diagnosed with chronic inflammatory demyleinating polyneuropathy attending neuropsychiatry department Assiut university From January 2023 to December 2026
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