NCT05219383

Brief 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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started Jan 2023

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Jan 2023Dec 2026

First Submitted

Initial submission to the registry

December 31, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 2, 2022

Status Verified

January 1, 2022

Enrollment Period

3.9 years

First QC Date

December 31, 2021

Last Update Submit

January 20, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Age \> 18 years, both sexes, history of sensory and/or motor complaint with progressive course over more 2 months

You may qualify if:

  • Age \> 18 years, both sexes, history of sensory and/or motor complaint with progressive course over more 2 months

You may not qualify if:

  • \*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 ..

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Rajabally YA, Nicolas G, Pieret 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.

    PMID: 19622522BACKGROUND
  • 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.

    PMID: 24338746BACKGROUND
  • 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. No abstract available.

    PMID: 21537353BACKGROUND

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

PolyradiculoneuropathyAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

December 31, 2021

First Posted

February 2, 2022

Study Start

January 1, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 2, 2022

Record last verified: 2022-01