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Chronic Inflammatory Demyelinating PolyneuropathyNCT05219383

Clinical and Electrophysiological Patterns of Chronic Dysimmune Polyneuropathy

An observational study of Chronic Inflammatory Demyelinating Polyneuropathy, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
How many people
36 participants
Where
No sites listed yet
Study dates
Jan 2023to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • *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 ..

About this study

Official title: Clinical and Electrophysiological Patterns of Chronic Dysimmune Polyneuropathy Among Patients Attending Neuropsychiatry Department - Assiut University

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

Read the detailed 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

Medical subject headings
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From January 2023 to December 2026

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2022
  2. Study startJan 2023 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05219383
Sponsor's protocol ID
Chronic dysimmune neuropathy
Status last verified
Jan 2022
First submitted
31 Dec 2021
Last updated
2 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 19622522

  • 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.

    PubMed 24338746

  • 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.

    PubMed 21537353

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Inflammatory Demyelinating Polyneuropathy, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients diagnosed with chronic inflammatory demyleinating polyneuropathy attending neuropsychiatry department Assiut university (time frame: From January 2023 to December 2026). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05219383, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.

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