CIDPNCT05614128
Validation of Cutaneous Nerve Demyelination in Diagnosis and Treatment of CIDP
An observational study of CIDP, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The goal of this observational study is to learn about chronic inflammatory demyelinating polyneuropathy. The main question the investigators would like to answer is 1) can skin biopsy identify demyelination better than nerve conduction studies (electrical tests of the nerves)? and 2) how do nerves improve after… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- CIDP
- What is being tested?
- IVIg
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2023to 19 Sep 2024
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed patients with CIDP prior or within 12 months of treatment with IVIg.
Who may be able to join
- Adults (age ≥ 18 years) with definite or probable CIDP according to the EFNS/PNS criteria may enter the trial within 12 months of treatment onset or treatment naïve patients. Written informed consent is obtained by the local investigator before entry into the study.
- 2. IVIg treatment of 0.8 up to 1.2 g/kg per 30 days will be allowed up to 6 months. It is expected some patients may be on variable treatment regimens, and as along as they are not significantly declining, efforts will be made to continue treatment regimens already instituted.
- 3. Prednisone in doses up to 20 mg /day will be allowed as long as dose has been stable for 90 days and is not being escalated or tapered during study.
- 4. Previous plasma exchange will be allowed as long as it is not continued during the study.
Who cannot join
- 1. Other causes of polyneuropathy, multifocal motor neuropathy, diabetes mellitus, alcohol, family history of neuropathy, monoclonal gammopathy or malignancy, history of drug or toxin exposure, which could reasonably cause neuropathy. Coexistent monoclonal gammopathy will also be used as an exclusion as these patients may not have the same response to IVIg.
- 2. Any other disease that may cause neurological symptoms and signs or that may interfere with treatment or outcome assessments.
- 3. Severe conditions that may interfere with an evaluation of the study product or satisfactory conduct of the study such as current malignancy or history of allogeneic bone marrow/stem cell transplant, cardiac insufficiency (New York Heart Association Classes III/IV), cardiomyopathy, cardiac arrhythmia requiring treatment, unstable or advanced ischemic heart disease, congestive heart failure or severe hypertension, chronic kidney disease deemed too severe to safely use IVIg, known hyperprolinemia, known bleeding disorders, severe skin disease at the planned injection sites or biopsy site, alcohol, drug or medication abuse.
- 4. History of keloids or other reactions to local anesthetic making skin biopsies unsafe.
- 5. Patients with the following laboratory results:
- Positive result at screening on any of the following viral markers: human immunodeficiency virus-1 or 2, or hepatitis B or C virus.
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- Abnormal laboratory parameters: creatinine greater than 1.5 times the upper limit of normal (ULN), blood urea nitrogen greater than three times the ULN if the increase is related to potential kidney disease, or hemoglobin less than 10 g/dL
- Abnormal laboratory parameters: creatinine greater than 1.5 times the upper limit of normal (ULN), blood urea nitrogen greater than three times the ULN if the increase is related to potential kidney disease, or hemoglobin less than 10 g/dL 6. Fulfilling the following general criteria: inability to comply with study procedures and treatment regimen; mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study; pregnancy or nursing mother; intention to become pregnant during the course of the study; female patients of childbearing potential either not using or not willing to use a medically reliable method of contraception for the entire duration of the study or not sexually abstinent for the entire duration of the study or not surgically sterile; participation in another clinical study or use of another investigational medicinal product within the same time period of the study.
- 7. Additional medications and treatments other than prednisone and IVIg for treatment of CIDP such as azathioprine, mycophenolate, rituximab and ongoing plasma exchange as this will either confound or interfere with effects of IVIg.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to learn about chronic inflammatory demyelinating polyneuropathy. The main question the investigators would like to answer is 1) can skin biopsy identify demyelination better than nerve conduction studies (electrical tests of the nerves)? and 2) how do nerves improve after treatment in CIDP? Participants will be asked to undergo skin biopsy of the finger at baseline and at 3 months and 6 months after treatment with IVIG (which is the FDA approved treatment for CIDP).
Read the detailed description
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) is an autoimmune disorder that can cause severe weakness and numbness, difficulty walking if untreated. CIDP is a disorder where the myelin or outside covering of the nerves which protect nerves and speed conduction are damaged by the immune system. The typical way CIDP is diagnosed is by performing electrical stimulation of the nerves (nerve conduction study or NCS) which may not be very accurate in identifying CIDP. The investigators also are not clear on how CIDP nerve impairment improves with treatment after IVIg, which is the recommended treatment. This study uses skin biopsy of the finger to look at the nerves and see if abnormalities of myelin such as segmental demyelination (loss of myelin along the course of the nerve) can be detected under microscope. The investigators will repeat the skin biopsy during treatment with IVIg (brand Privigen which is FDA approved for CIDP) to determine how IVIg improves nerves during treatment. The investigators hope this study will provide both better ways to diagnose patients with CIDP as well as inform doctors on how CIDP can improve with treatment.
The investigators are recruiting patients newly diagnosed or within 6 months of diagnosis to study the use of skin biopsies in diagnosis of CIDP. The investigators are also repeating skin biopsies at 3 months and 6 months to measure improvement in nerve demyelination.
- Conditions
- CIDP
- Being tested
- IVIg
- 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.
IVIgOther
Patients will be treated with IVIg as recommended by expert guidelines for treatment of CIDP under care of their primary neurologist. This will not be provided by the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of cutaneous nerves with segmental demyelination
Number of nerve fibers with demyelination visualized under microscopy will be calculated per biopsy.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start28 Feb 2023
- Primary completion19 Sep 2024
- Study completion19 Sep 2024
Why it stopped: Difficulty with Recruitment, Lack of Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CIDPStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- CSL Behring
- Responsible party
- Principal investigator, Amanda Peltier, Vanderbilt University Medical Center
- Investigators
- Wende Fedder, Rn, Study director, Vanderbilt University Medical CenterDiana Davis, RN, Study director, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614128
- Sponsor's protocol ID
- VR64081
- Status last verified
- Jun 2025
- First submitted
- 31 Oct 2022
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Cutaneous Nerve Demyelination in Diagnosis and Treatment of CIDP
- ClinicalTrials.gov ID
- NCT05614128
- Acronym / sponsor ID
- VR64081
- Conditions
- CIDP
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty with Recruitment, Lack of Funding
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- CSL Behring
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 14 Nov 2022 (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.
The goal of this observational study is to learn about chronic inflammatory demyelinating polyneuropathy. The main question the investigators would like to answer is 1) can skin biopsy identify demyelination better than nerve conduction studies (electrical tests of the nerves)? and 2) how do nerves improve after treatment in CIDP? Participants will be asked to undergo skin biopsy of the finger at baseline and at 3 months and 6 months after treatment with IVIG (which is the FDA approved treatment for CIDP).
Detailed description
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) is an autoimmune disorder that can cause severe weakness and numbness, difficulty walking if untreated. CIDP is a disorder where the myelin or outside covering of the nerves which protect nerves and speed conduction are damaged by the immune system. The typical way CIDP is diagnosed is by performing electrical stimulation of the nerves (nerve conduction study or NCS) which may not be very accurate in identifying CIDP. The investigators also are not clear on how CIDP nerve impairment improves with treatment after IVIg, which is the recommended treatment. This study uses skin biopsy of the finger to look at the nerves and see if abnormalities of myelin such as segmental demyelination (loss of myelin along the course of the nerve) can be detected under microscope. The investigators will repeat the skin biopsy during treatment with IVIg (brand Privigen which is FDA approved for CIDP) to determine how IVIg improves nerves during treatment. The investigators hope this study will provide both better ways to diagnose patients with CIDP as well as inform doctors on how CIDP can improve with treatment.
The investigators are recruiting patients newly diagnosed or within 6 months of diagnosis to study the use of skin biopsies in diagnosis of CIDP. The investigators are also repeating skin biopsies at 3 months and 6 months to measure improvement in nerve demyelination.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed patients with CIDP prior or within 12 months of treatment with IVIg.
Key inclusion criteria (4 listed)
- Adults (age ≥ 18 years) with definite or probable CIDP according to the EFNS/PNS criteria may enter the trial within 12 months of treatment onset or treatment naïve patients. Written informed consent is obtained by the local investigator before entry into the study.
- 2. IVIg treatment of 0.8 up to 1.2 g/kg per 30 days will be allowed up to 6 months. It is expected some patients may be on variable treatment regimens, and as along as they are not significantly declining, efforts will be made to continue treatment regimens already instituted.
- 3. Prednisone in doses up to 20 mg /day will be allowed as long as dose has been stable for 90 days and is not being escalated or tapered during study.
- 4. Previous plasma exchange will be allowed as long as it is not continued during the study.
Key exclusion criteria (9 listed)
- 1. Other causes of polyneuropathy, multifocal motor neuropathy, diabetes mellitus, alcohol, family history of neuropathy, monoclonal gammopathy or malignancy, history of drug or toxin exposure, which could reasonably cause neuropathy. Coexistent monoclonal gammopathy will also be used as an exclusion as these patients may not have the same response to IVIg.
- 2. Any other disease that may cause neurological symptoms and signs or that may interfere with treatment or outcome assessments.
- 3. Severe conditions that may interfere with an evaluation of the study product or satisfactory conduct of the study such as current malignancy or history of allogeneic bone marrow/stem cell transplant, cardiac insufficiency (New York Heart Association Classes III/IV), cardiomyopathy, cardiac arrhythmia requiring treatment, unstable or advanced ischemic heart disease, congestive heart failure or severe hypertension, chronic kidney disease deemed too severe to safely use IVIg, known hyperprolinemia, known bleeding disorders, severe skin disease at the planned injection sites or biopsy site, alcohol, drug or medication abuse.
- 4. History of keloids or other reactions to local anesthetic making skin biopsies unsafe.
- 7. Additional medications and treatments other than prednisone and IVIg for treatment of CIDP such as azathioprine, mycophenolate, rituximab and ongoing plasma exchange as this will either confound or interfere with effects of IVIg.
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 |
|---|---|---|
| IVIgPatients will be treated with IVIg as recommended by expert guidelines for treatment of CIDP under care of their primary neurologist. This will not be provided by the study. | Other | – |
Primary outcome
Percentage of cutaneous nerves with segmental demyelination
Time frame: 6 months
Number of nerve fibers with demyelination visualized under microscopy will be calculated per biopsy.
Results and safety
The study was stopped early (reason given: Difficulty with Recruitment, Lack of Funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
Wende Fedder, Rn study director
Vanderbilt University Medical Center
Diana Davis, RN study director
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CIDP, run by Vanderbilt University Medical Center at 1 site in United States.
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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: Difficulty with Recruitment, Lack of Funding). Results are not available in the source record.
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?
Percentage of cutaneous nerves with segmental demyelination (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2025.