Chronic Inflammatory Demyelinating PolyradiculoneuropathySW_CIDPNCT04529291
InertiaLocoGraphy as a Biomarker of Immunoglobulin Therapy Efficacy in Chronic Inflammatory Demyelinating Polyradiculoneuropathy
A study testing Group with walking disorder and Group without walking disorder in people with Chronic Inflammatory Demyelinating Polyradiculoneuropathy, run by Fondation Hôpital Saint-Joseph.
Trial summary
Chronic inflammatory demyelinating polyradiculoneuropathy is a diffuse multifocal autoimmune disorder of the peripheral neuron, affecting 1 to 9 in 100,000 people. Its course is difficult to predict, and may be characterized by continuous progression, multiple relapses, or recovery after a few months. treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- What is being tested?
- Group with walking disorder and Group without walking disorder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 16 Apr 2022to 16 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient whose age is ≥ 18 years
- Patient diagnosed with chronic inflammatory demyelinating polyneuropathy (CIDP) in one of the following two cases:
- Certain IPDC according to ENFS / PNS 2010 criteria
- Possible or probable CIDP according to ENFS / PNS 2010 criteria with favorable response to immunomodulatory treatment 23
- Patient treated with IVIG
- Mobile patient, able to walk 2 sets of 20 m with a half turn, with a 3 min break between the two exercises.
Show all 12Show fewer
- Patients will be included in one of the following two groups:
- G_CIDP: if the patient reports walking disorders due to his illness
- NG_CIDP: otherwise
- Patient living in an area accessible by public transport with a journey time of 1 hour (sector ≈ 5 - 6 km)
- Patient affiliated to a social security scheme
- Patient who has given oral, free, informed and express consent
Who cannot join
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Pregnant woman
- Patient with a pathology other than IPDC that may affect walking (muscular-skeletal pathology, other neurological pathology, etc.) according to the attached clinical questionnaire
About this study
Chronic inflammatory demyelinating polyradiculoneuropathy is a diffuse multifocal autoimmune disorder of the peripheral neuron, affecting 1 to 9 in 100,000 people. Its course is difficult to predict, and may be characterized by continuous progression, multiple relapses, or recovery after a few months. treatment. The predominantly motor form with 4 limbs represents the typical form, but the disease can take on other clinical forms (pure sensory impairment, ataxia, etc.).
In addition to induction therapy, patients most often require long-term maintenance therapy. First-line therapies, with the same efficacy according to a 2013 Cochrane study, are glucocorticoid therapy, plasma exchanges and intravenous immunoglobulin injections. Glucocorticoids have a grade C recommendation level while a grade A has been assigned to intravenous immunoglobulins and plasma exchange. However, the latter have less tolerance and have a rebound effect which limits their long-term interest. Intravenous immunoglobulins are therefore the preferred treatment today. The effect of intravenous immunoglobulins, delivered as a bolus over a few days, lasts two to six weeks, with the number of people being cured of three to improve a person. A more recent study has also shown their advantage in reducing the relapse rate at 6 months.
Read more
However, the response to intravenous immunoglobulins fluctuates in different patients and, for any given patient, changes over the course of the disease. The 2010 recommendations therefore recommend an adaptation of the doses and duration of intercourse (0.4 to 1.2 g / kg every 2 to 6 weeks) according to individual monitoring of the response to treatment. In order to embrace the diversity of symptoms of chronic inflammatory demyelinating polyradiculoneuropathy, several scores and scales are usually combined to ensure this follow-up in a cohort. Three clinical data are currently favored: the Inflammatory Rasch-built Overall Disability Scale (I-RODS), the INCAT Overall Neuropathy Limitations Scale (ONLS), the score of the Medical Research Council (MRC). However, none of them assess walking objectively.
However, patients with chronic inflammatory demyelinating polyradiculoneuropathy sometimes report significant walking disturbances, which may result from both sensory disturbances or motor disturbances present in varying degrees depending on the patient. The alterations concerned, according to the studies, the walking speed, the temporal pattern of the step, with an impairment of the durations of the different phases (support and oscillation) or the angle and the angular speed of roll at the level of the trunk. Alterations in speed and phase duration of the step improve during treatment with intravenous immunoglobulin cures, with greater sensitivity compared to the ONLS and MRC scales. The power of the propulsive moment at the ankle during the last moments of the stance phase - the push-off - is another promising gait parameter that has made it possible to distinguish diabetic patients with polyneuropathy from those without diabetes. polyneuropathy and the intensity of the deficit is linked to the severity of the attack. Gait speed, as a reflection of the subject's gait performance, and the quality of gait including the timing of gait, trunk rotation movements and push-off, therefore seem to be potential response markers. for monitoring patients treated with intravenous immunoglobulins.
InertiaLocoGraphy, quantification of gait by inertial measurement sensors, has proven its value in the evaluation of various pathologies in neurological practice, including chronic inflammatory demyelinating polyradiculoneuropathy. It gives access to the walking speed as well as to various walking quality criteria (vigor of the step, rhythmicity, regularity, symmetry, stability, fluidity, synchronization) including the times of the different walking phases and the rotational movements of the trunk, and a push-off substitute.
InertiaLocoGraphie, non-invasive, easy and quick to set up, reflecting the patient's function, therefore potentially provides biomarkers of choice for monitoring the response to intravenous immunoglobulin cures in patients with chronic inflammatory polyradiculoneuropathy demyelinating. Its association with the traditional monitoring tools such as the ONLS score, the I-ROS, and the CRM therefore appears to be of key interest for this monitoring.
- Being tested
- Group with walking disorder, Group without walking disorder
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group with walking disorderOther
During the patient's hospitalization, two questionnaires will be completed, assessing the handicap of the patient in his daily activities, and the specific incapacity to carry out activities of daily living and social life (10 minutes to complete). The patient will then carry out two 20-meter round-trip walking tests during his first day and his last day of care at the hospital. Additional home visits, corresponding to intervention, performed by a member of the investigative team, will take place once a week (15-20 minutes). The team will collect his feelings about the evolution of symptoms through the two questionnaires, and quantify the evolution of his walking. Walk tests are recorded using small inertial sensors (accelerometers and gyrometers) that will be placed at his feet, belt and forehead. This examination is not painful. All the measurements are carried out in 15 minutes by a member of the team.
Group without walking disorderOther
During the patient's hospitalization, two questionnaires will be completed, assessing the handicap of the patient in his daily activities, and the specific incapacity to carry out activities of daily living and social life (10 minutes to complete). The patient will then carry out two 20-meter round-trip walking tests during his first day and his last day of care at the hospital.
Additional home visits, corresponding to interventions, performed by a member of the investigative team, will take place once a week (15-20 minutes). The team will collect his feelings about the evolution of symptoms through the two questionnaires, and quantify the evolution of his walking. Walk tests are recorded using small inertial sensors (accelerometers and gyrometers) that will be placed at his feet, belt and forehead. This examination is not painful. All the measurements are carried out in 15 minutes by a member of the team.
| Study group | Role | What they receive |
|---|---|---|
| Group with walking disorder | Other | This Group with walking disorder corresponds to patient reporting walking disorders due to his illness. Receives: Other: Group with walking disorder |
| Group without walking disorder | Other | This Group without walking disorder corresponds to patients not reporting walking disorders due to his illness. Receives: Other: Group without walking disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Push-off Variation between D1 and D15
This outcome corresponds to comparison of the absolute variation of Push-off (corresponding to the power of the moment of propulsion at the ankle during the last moments of the support phase) between D0 and D15 in the three subgroups defined by the change in ONLS at D15.
Measured: Day 15
Secondary outcomes (3)
Push-off Variation at Day 4
This outcome corresponds to comparison of the absolute variation of Push-off (corresponding to the power of the moment of propulsion at the ankle during the last moments of the support phase) between D0 and D4 in the three subgroups defined by the change in ONLS.
Measured: Day 4
Walking speed Variation at Day 4
This outcome corresponds to comparison of the absolute variation of the walking speed and the quality criteria of walking (vigor of the step, rhythmicity, regularity, symmetry, stability, fluidity, synchronization) between D0 and D4 in the three sub-groups defined by the change in ONLS on D15 (Subgroups: responders if ONLS decrease by more than 1 point, non-responder if ONLS is stable, progressors if ONLS increase by more than 1 point) in groups of patients with and without walking disorders
Measured: Day 4
Walking speed Variation at Day 15
This outcome corresponds to comparison of the absolute variation of the walking speed and the quality criteria of walking (vigor of the step, rhythmicity, regularity, symmetry, stability, fluidity, synchronization) between D0 and D15 in the three sub-groups defined by the change in ONLS on D15 (Subgroups: responders if ONLS decrease by more than 1 point, non-responder if ONLS is stable, progressors if ONLS increase by more than 1 point) in groups of patients with and without walking disorders
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start16 Apr 2022
- Primary completion16 Apr 2022
- Study completion16 Apr 2022
Why it stopped: The IP decided to stop.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Chronic Inflammatory Demyelinating PolyradiculoneuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline REACH, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529291
- Sponsor's protocol ID
- SW_CIDP
- Acronym
- SW_CIDP
- Status last verified
- Jun 2022
- First submitted
- 21 Aug 2020
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Laughlin RS, Dyck PJ, Melton LJ 3rd, Leibson C, Ransom J, Dyck PJ. Incidence and prevalence of CIDP and the association of diabetes mellitus. Neurology. 2009 Jul 7;73(1):39-45. doi: 10.1212/WNL.0b013e3181aaea47.
PubMed 19564582Dyck PJ, O'Brien PC, Oviatt KF, Dinapoli RP, Daube JR, Bartleson JD, Mokri B, Swift T, Low PA, Windebank AJ. Prednisone improves chronic inflammatory demyelinating polyradiculoneuropathy more than no treatment. Ann Neurol. 1982 Feb;11(2):136-41. doi: 10.1002/ana.410110205.
PubMed 7041788Eftimov F, Winer JB, Vermeulen M, de Haan R, van Schaik IN. Intravenous immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database Syst Rev. 2013 Dec 30;(12):CD001797. doi: 10.1002/14651858.CD001797.pub3.
PubMed 24379104Van den Bergh PY, Hadden RD, Bouche P, Cornblath DR, Hahn A, Illa I, Koski CL, Leger JM, Nobile-Orazio E, Pollard J, Sommer C, van Doorn PA, van Schaik IN; European Federation of Neurological Societies; Peripheral Nerve Society. European Federation of Neurological Societies/Peripheral Nerve Society guideline on management of chronic inflammatory demyelinating polyradiculoneuropathy: report of a joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society - first revision. Eur J Neurol. 2010 Mar;17(3):356-63. doi: 10.1111/j.1468-1331.2009.02930.x.
PubMed 20456730Adrichem ME, Eftimov F, van Schaik IN. Intravenous immunoglobulin treatment in chronic inflammatory demyelinating polyradiculoneuropathy, a time to start and a time to stop. J Peripher Nerv Syst. 2016 Sep;21(3):121-7. doi: 10.1111/jns.12176.
PubMed 27241239Hughes RA, Donofrio P, Bril V, Dalakas MC, Deng C, Hanna K, Hartung HP, Latov N, Merkies IS, van Doorn PA; ICE Study Group. Intravenous immune globulin (10% caprylate-chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study): a randomised placebo-controlled trial. Lancet Neurol. 2008 Feb;7(2):136-44. doi: 10.1016/S1474-4422(07)70329-0.
PubMed 18178525Kuitwaard K, van Doorn PA. Newer therapeutic options for chronic inflammatory demyelinating polyradiculoneuropathy. Drugs. 2009 May 29;69(8):987-1001. doi: 10.2165/00003495-200969080-00004.
PubMed 19496628Debs R, Reach P, Cret C, Demeret S, Saheb S, Maisonobe T, Viala K. A new treatment regimen with high-dose and fractioned immunoglobulin in a special subgroup of severe and dependent CIDP patients. Int J Neurosci. 2017 Oct;127(10):864-872. doi: 10.1080/00207454.2016.1269328. Epub 2016 Dec 20.
PubMed 27918219Oudre L, Barrois-Muller R, Moreau T, Truong C, Vienne-Jumeau A, Ricard D, Vayatis N, Vidal PP. Template-Based Step Detection with Inertial Measurement Units. Sensors (Basel). 2018 Nov 19;18(11):4033. doi: 10.3390/s18114033.
PubMed 30463240Antoine JC, Azulay JP, Bouche P, Creange A, Fournier E, Gallouedec G, Lagueny A, Lefaucheur JP, Leger JM, Magy L, Maisonobe T, Nicolas G, Pouget J, Soichot P, Stojkovic T, Vallat JM, Verschueren A, Vial C, Viala K; Groupe d'Etude francais des PIDC. [Chronic inflammatory demyelinating polyradiculoneuropathy: diagnostic strategy. Guidelines of the French CIDP study group]. Rev Neurol (Paris). 2005 Oct;161(10):988-96. doi: 10.1016/s0035-3787(05)85166-5. French.
PubMed 16365632Vienne A, Barrois RP, Buffat S, Ricard D, Vidal PP. Inertial Sensors to Assess Gait Quality in Patients with Neurological Disorders: A Systematic Review of Technical and Analytical Challenges. Front Psychol. 2017 May 18;8:817. doi: 10.3389/fpsyg.2017.00817. eCollection 2017.
PubMed 28572784Vienne-Jumeau A, Oudre L, Moreau A, Quijoux F, Edmond S, Dandrieux M, Legendre E, Vidal PP, Ricard D. Personalized Template-Based Step Detection From Inertial Measurement Units Signals in Multiple Sclerosis. Front Neurol. 2020 Apr 21;11:261. doi: 10.3389/fneur.2020.00261. eCollection 2020.
PubMed 32373047Andersen H, Jakobsen J. A comparative study of isokinetic dynamometry and manual muscle testing of ankle dorsal and plantar flexors and knee extensors and flexors. Eur Neurol. 1997;37(4):239-42. doi: 10.1159/000117450.
PubMed 9208265Rao S, Saltzman C, Yack HJ. Ankle ROM and stiffness measured at rest and during gait in individuals with and without diabetic sensory neuropathy. Gait Posture. 2006 Nov;24(3):295-301. doi: 10.1016/j.gaitpost.2005.10.004. Epub 2005 Nov 15.
PubMed 16293415
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InertiaLocoGraphy as a Biomarker of Immunoglobulin Therapy Efficacy in Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- ClinicalTrials.gov ID
- NCT04529291
- Acronym / sponsor ID
- SW_CIDP / SW_CIDP
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The IP decided to stop.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 16 Apr 2022 (actual)
- Primary completion
- 16 Apr 2022 (actual)
- Study completion
- 16 Apr 2022 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic inflammatory demyelinating polyradiculoneuropathy is a diffuse multifocal autoimmune disorder of the peripheral neuron, affecting 1 to 9 in 100,000 people. Its course is difficult to predict, and may be characterized by continuous progression, multiple relapses, or recovery after a few months. treatment. The predominantly motor form with 4 limbs represents the typical form, but the disease can take on other clinical forms (pure sensory impairment, ataxia, etc.).
In addition to induction therapy, patients most often require long-term maintenance therapy. First-line therapies, with the same efficacy according to a 2013 Cochrane study, are glucocorticoid therapy, plasma exchanges and intravenous immunoglobulin injections. Glucocorticoids have a grade C recommendation level while a grade A has been assigned to intravenous immunoglobulins and plasma exchange. However, the latter have less tolerance and have a rebound effect which limits their long-term interest. Intravenous immunoglobulins are therefore the preferred treatment today. The effect of intravenous immunoglobulins, delivered as a bolus over a few days, lasts two to six weeks, with the number of people being cured of three to improve a person. A more recent study has also shown their advantage in reducing the relapse rate at 6 months.
However, the response to intravenous immunoglobulins fluctuates in different patients and, for any given patient, changes over the course of the disease. The 2010 recommendations therefore recommend an adaptation of the doses and duration of intercourse (0.4 to 1.2 g / kg every 2 to 6 weeks) according to individual monitoring of the response to treatment. In order to embrace the diversity of symptoms of chronic inflammatory demyelinating polyradiculoneuropathy, several scores and scales are usually combined to ensure this follow-up in a cohort. Three clinical data are currently favored: the Inflammatory Rasch-built Overall Disability Scale (I-RODS), the INCAT Overall Neuropathy Limitations Scale (ONLS), the score of the Medical Research Council (MRC). However, none of them assess walking objectively.
However, patients with chronic inflammatory demyelinating polyradiculoneuropathy sometimes report significant walking disturbances, which may result from both sensory disturbances or motor disturbances present in varying degrees depending on the patient. The alterations concerned, according to the studies, the walking speed, the temporal pattern of the step, with an impairment of the durations of the different phases (support and oscillation) or the angle and the angular speed of roll at the level of the trunk. Alterations in speed and phase duration of the step improve during treatment with intravenous immunoglobulin cures, with greater sensitivity compared to the ONLS and MRC scales. The power of the propulsive moment at the ankle during the last moments of the stance phase - the push-off - is another promising gait parameter that has made it possible to distinguish diabetic patients with polyneuropathy from those without diabetes. polyneuropathy and the intensity of the deficit is linked to the severity of the attack. Gait speed, as a reflection of the subject's gait performance, and the quality of gait including the timing of gait, trunk rotation movements and push-off, therefore seem to be potential response markers. for monitoring patients treated with intravenous immunoglobulins.
InertiaLocoGraphy, quantification of gait by inertial measurement sensors, has proven its value in the evaluation of various pathologies in neurological practice, including chronic inflammatory demyelinating polyradiculoneuropathy. It gives access to the walking speed as well as to various walking quality criteria (vigor of the step, rhythmicity, regularity, symmetry, stability, fluidity, synchronization) including the times of the different walking phases and the rotational movements of the trunk, and a push-off substitute.
InertiaLocoGraphie, non-invasive, easy and quick to set up, reflecting the patient's function, therefore potentially provides biomarkers of choice for monitoring the response to intravenous immunoglobulin cures in patients with chronic inflammatory polyradiculoneuropathy demyelinating. Its association with the traditional monitoring tools such as the ONLS score, the I-ROS, and the CRM therefore appears to be of key interest for this monitoring.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with walking disorder | Other | Other: Group with walking disorderThis Group with walking disorder corresponds to patient reporting walking disorders due to his illness. |
| Group without walking disorder | Other | Other: Group without walking disorderThis Group without walking disorder corresponds to patients not reporting walking disorders due to his illness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient whose age is ≥ 18 years
- Patient diagnosed with chronic inflammatory demyelinating polyneuropathy (CIDP) in one of the following two cases:
- Patient treated with IVIG
- Mobile patient, able to walk 2 sets of 20 m with a half turn, with a 3 min break between the two exercises.
- G_CIDP: if the patient reports walking disorders due to his illness
Key exclusion criteria (4 listed)
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Pregnant woman
- Patient with a pathology other than IPDC that may affect walking (muscular-skeletal pathology, other neurological pathology, etc.) according to the attached clinical questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group with walking disorderDuring the patient's hospitalization, two questionnaires will be completed, assessing the handicap of the patient in his daily activities, and the specific incapacity to carry out activities of daily living and social life (10 minutes to complete). The patient will then carry out two 20-meter round-trip walking tests during his first day and his last day of care at the hospital. Additional home visits, corresponding to intervention, performed by a member of the investigative team, will take place once a week (15-20 minutes). The team will collect his feelings about the evolution of symptoms through the two questionnaires, and quantify the evolution of his walking. Walk tests are recorded using small inertial sensors (accelerometers and gyrometers) that will be placed at his feet, belt and forehead. This examination is not painful. All the measurements are carried out in 15 minutes by a member of the team. | Other | Group with walking disorder |
| Group without walking disorderDuring the patient's hospitalization, two questionnaires will be completed, assessing the handicap of the patient in his daily activities, and the specific incapacity to carry out activities of daily living and social life (10 minutes to complete). The patient will then carry out two 20-meter round-trip walking tests during his first day and his last day of care at the hospital. Additional home visits, corresponding to interventions, performed by a member of the investigative team, will take place once a week (15-20 minutes). The team will collect his feelings about the evolution of symptoms through the two questionnaires, and quantify the evolution of his walking. Walk tests are recorded using small inertial sensors (accelerometers and gyrometers) that will be placed at his feet, belt and forehead. This examination is not painful. All the measurements are carried out in 15 minutes by a member of the team. | Other | Group without walking disorder |
Primary outcome
Push-off Variation between D1 and D15
Time frame: Day 15
This outcome corresponds to comparison of the absolute variation of Push-off (corresponding to the power of the moment of propulsion at the ankle during the last moments of the support phase) between D0 and D15 in the three subgroups defined by the change in ONLS at D15.
3 secondary outcomes
Push-off Variation at Day 4
Time frame: Day 4
Walking speed Variation at Day 4
Time frame: Day 4
Walking speed Variation at Day 15
Time frame: Day 15
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Results publication: PubMed 19564582Laughlin RS, Dyck PJ, Melton LJ 3rd, Leibson C, Ransom J, Dyck PJ. Incidence and prevalence of CIDP and the association of diabetes mellitus. Neurology. 2009 Jul 7;73(1):39-45. doi: 10.1212/WNL.0b013e3181aaea47.
- Results publication: PubMed 7041788Dyck PJ, O'Brien PC, Oviatt KF, Dinapoli RP, Daube JR, Bartleson JD, Mokri B, Swift T, Low PA, Windebank AJ. Prednisone improves chronic inflammatory demyelinating polyradiculoneuropathy more than no treatment. Ann Neurol. 1982 Feb;11(2):136-41. doi: 10.1002/ana.410110205.
- Results publication: PubMed 24379104Eftimov F, Winer JB, Vermeulen M, de Haan R, van Schaik IN. Intravenous immunoglobulin for chronic inflammatory demyelinating polyradiculoneuropathy. Cochrane Database Syst Rev. 2013 Dec 30;(12):CD001797. doi: 10.1002/14651858.CD001797.pub3.
- Results publication: PubMed 20456730Van den Bergh PY, Hadden RD, Bouche P, Cornblath DR, Hahn A, Illa I, Koski CL, Leger JM, Nobile-Orazio E, Pollard J, Sommer C, van Doorn PA, van Schaik IN; European Federation of Neurological Societies; Peripheral Nerve Society. European Federation of Neurological Societies/Peripheral Nerve Society guideline on management of chronic inflammatory demyelinating polyradiculoneuropathy: report of a joint task force of the European Federation of Neurological Societies and the Peripheral Nerve Society - first revision. Eur J Neurol. 2010 Mar;17(3):356-63. doi: 10.1111/j.1468-1331.2009.02930.x.
- Results publication: PubMed 27241239Adrichem ME, Eftimov F, van Schaik IN. Intravenous immunoglobulin treatment in chronic inflammatory demyelinating polyradiculoneuropathy, a time to start and a time to stop. J Peripher Nerv Syst. 2016 Sep;21(3):121-7. doi: 10.1111/jns.12176.
- Results publication: PubMed 18178525Hughes RA, Donofrio P, Bril V, Dalakas MC, Deng C, Hanna K, Hartung HP, Latov N, Merkies IS, van Doorn PA; ICE Study Group. Intravenous immune globulin (10% caprylate-chromatography purified) for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (ICE study): a randomised placebo-controlled trial. Lancet Neurol. 2008 Feb;7(2):136-44. doi: 10.1016/S1474-4422(07)70329-0.
- Results publication: PubMed 19496628Kuitwaard K, van Doorn PA. Newer therapeutic options for chronic inflammatory demyelinating polyradiculoneuropathy. Drugs. 2009 May 29;69(8):987-1001. doi: 10.2165/00003495-200969080-00004.
- Results publication: PubMed 27918219Debs R, Reach P, Cret C, Demeret S, Saheb S, Maisonobe T, Viala K. A new treatment regimen with high-dose and fractioned immunoglobulin in a special subgroup of severe and dependent CIDP patients. Int J Neurosci. 2017 Oct;127(10):864-872. doi: 10.1080/00207454.2016.1269328. Epub 2016 Dec 20.
- Results publication: PubMed 30463240Oudre L, Barrois-Muller R, Moreau T, Truong C, Vienne-Jumeau A, Ricard D, Vayatis N, Vidal PP. Template-Based Step Detection with Inertial Measurement Units. Sensors (Basel). 2018 Nov 19;18(11):4033. doi: 10.3390/s18114033.
- Results publication: PubMed 16365632Antoine JC, Azulay JP, Bouche P, Creange A, Fournier E, Gallouedec G, Lagueny A, Lefaucheur JP, Leger JM, Magy L, Maisonobe T, Nicolas G, Pouget J, Soichot P, Stojkovic T, Vallat JM, Verschueren A, Vial C, Viala K; Groupe d'Etude francais des PIDC. [Chronic inflammatory demyelinating polyradiculoneuropathy: diagnostic strategy. Guidelines of the French CIDP study group]. Rev Neurol (Paris). 2005 Oct;161(10):988-96. doi: 10.1016/s0035-3787(05)85166-5. French.
- Results publication: PubMed 28572784Vienne A, Barrois RP, Buffat S, Ricard D, Vidal PP. Inertial Sensors to Assess Gait Quality in Patients with Neurological Disorders: A Systematic Review of Technical and Analytical Challenges. Front Psychol. 2017 May 18;8:817. doi: 10.3389/fpsyg.2017.00817. eCollection 2017.
- Results publication: PubMed 32373047Vienne-Jumeau A, Oudre L, Moreau A, Quijoux F, Edmond S, Dandrieux M, Legendre E, Vidal PP, Ricard D. Personalized Template-Based Step Detection From Inertial Measurement Units Signals in Multiple Sclerosis. Front Neurol. 2020 Apr 21;11:261. doi: 10.3389/fneur.2020.00261. eCollection 2020.
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Charcot-Marie-Tooth, CMT1A
Active, not recruitingPhase 2
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
RecruitingPhase 2/3
Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pauline REACH, MD principal investigator
Fondation Hôpital Saint-Joseph
Questions about this trial
What is this clinical trial studying?
A study testing Group with walking disorder and Group without walking disorder in people with Chronic Inflammatory Demyelinating Polyradiculoneuropathy, run by Fondation Hôpital Saint-Joseph.
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 12 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: withdrawn, as of the sponsor's last update on 5 Jul 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Push-off Variation between D1 and D15 (time frame: Day 15). 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 NCT04529291, which also lists 14 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 5 Jul 2022.