ClinicalTrials.gg
CompletedNCT03967899PRONELEC PIDCUpdated Mar 31, 2022

Study of Electrical Prognostic Factors of Response to Intravenous Immunoglobulin Treatment in Chronic Inflammatory Demyelinating Polyradiculoneuropathy

An observational study in Chronic Inflammatory Demyelinating Polyradiculoneuropathy, sponsored by Fondation Hôpital Saint-Joseph. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Fondation Hôpital Saint-Joseph · Observational

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
42
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 38 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in France — 8 open to participants now, 10 under way, 7 of them phase 3. Polyradiculoneuropathy, Chronic Inflammatory Demyelinating · France.

Started
2019
with 2 others
Observational
9 of 38
2 open now
Registered
19th of 38
by date

Among the 38 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in France, this one is one of 3 that started in 2019, is one of 9 observational ones, and was the 19th registered.

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

137 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 51 are open to participants now.

Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →

Open to participants now

8 of the 38 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in France are open now. Recruiting first, the newest first:

3 more — sign in →

All 8 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 36 Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies recruiting now, 24 (67%) set no upper age limit and 9 (25%) stop at 75 or younger; 4 take children under 18; 2 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 38 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in France, or all of them as a file.
02

Study summary

Chronic inflammatory demyelinating polyradiculoneuropathy (PIDC) is an acquired dysimmune polyneuropathy whose prevalence is estimated to be between 1 to 4 per 100,000 depending on the study, with an incidence of less than 1 per 100,000 per year. The clinical presentation of PIDC is heterogeneous, characterized by a symmetrical lesion predominating generally on large fibers, the most myelinated, responsible for ataxia and a motor deficit in the foreground. In the typical form, patients describe a proximal and distal motor or sensory deficit associated with isflexia that signifies a peripheral neurogenic syndrome.

The physiopathological hypothesis is that of an inflammation responsible for demyelinating nerve fibers, which results in electroneuromyogram (ENMG) by conduction abnormalities and histologically when a neuromuscular biopsy is performed by segmental demyelination.

Given the heterogeneity of the clinical presentation, electrical diagnostic criteria are proposed by the European Federation of Neurological Society in order to classify IPDCs into three categories: certain, probable and possible. In the absence of sufficient criteria to make the diagnosis of IPDC, it is also possible to use criteria of support, using a paraclinical report including the presence of an increase in protein (hyperproteinorachie) without cells for cerebrospinal fluid analysis, visualization of radicular inflammation on imaging (MRI of lumbar and / or brachial plexus), proximal peripheral involvement with somatosensory evoked potentials.

Therapeutically, a joint management between rehabilitation and the introduction of a background treatment allows the clinical improvement of certain patients. To date, the treatments proposed in first intention are corticosteroids, intravenous immunoglobulins (IVIg) and plasma exchanges. In fact, the efficacy of intravenous immunoglobulins has been widely shown by controlled and randomized therapeutic trials. Efficacy studies of IVIg in the literature are most often based on an assessment of clinical response after 24 weeks, but in clinical practice the response to treatment and continuation of treatment is often evaluated after 3 courses of treatment with the help of a clinical evaluation and the realization of an electroneuromyogram. These are administered in day hospitalization or traditional hospitalization, every four weeks, to patients whose diagnosis of PIDC has been established by electroneuromyogram according to the EFNS criteria.

Clinical prognostic factors for good response to IVIG therapy have been described in previous studies, including subacute disease, symmetrical involvement, and absence of amyotrophy.

In order to optimize the management of IPDCs, it is important to identify patients who respond to IVIg. Thus, the objective of our study is to look at the electroneuromyogram, the presence of electrical predictors of good response to treatment with IVIg.

03

Conditions studied

  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with IPDC, hospitalized in a traditional hospital ward or week hospital or day hospital, who received at least 3 courses of IVIG under IPDC between January 2014 and March 2019

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients whose age is ≥ 18 years
  • Patients with IPDC
  • Patients hospitalized in a traditional hospital ward or week hospital or day hospital
  • Patients who received at least 3 courses of IVIG under IPDC between January 2014 and March 2019
  • Francophone patients

Exclusion criteria

Exclusion Criteria:

  • Patients under guardianship or curatorship
  • Patients deprived of their liberty
  • Patients who oppose the use of their data for this research
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
42 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Identify electromyographic predictors of treatment response

    This corresponds to highlight, in the data of the electroneuromyogram performed before the initiation of treatment with IVIg, differences between the responder groups or not treatment \[decrease of at least 1 point in the ONLS score\], i.e three courses of IVIG.

    Time frame: Week 24

Secondary outcomes

  1. study of the demographic characteristics of patients followed for IPDC and treated with IVIg

    This corresponds to percentage of patients with a certain / probable or possible IPDC.

    Time frame: Week 24

  2. Clinical evidence of response to IVIG treatment

    comparison of the results of the complementary explorations in the patients answering or not to the treatment

    Time frame: Week 24

07

Study locations

1 site
  • Groupe Hospitalier Paris Saint-Joseph
    Paris, 75014, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2019 to primary completion in Oct 2020, 15 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 24, 2019
First posted
May 30, 2019
StartActual
Jul 17, 2019
Primary completionActual
Oct 31, 2020
CompletionActual
Oct 28, 2021
Last update
Mar 31, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03967899
Responsible party
Sponsor
First posted
May 30, 2019
Start date
Jul 17, 2019
Primary completion
Oct 31, 2020
Completion
Oct 28, 2021
Last update
Mar 31, 2022

Study contacts

Pauline REACH, MD
principal investigator · Fondation Hôpital Saint-Joseph

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion