Trial · NCT03401073
IVIg for Small Fiber Neuropathy With Autoantibodies TS-HDS and FGFR3
NCT03401073, Phase 2, Completed, Beth Israel Deaconess Medical Center; results first posted 2023-09-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. IVIg for Small Fiber Neuropathy With Autoantibodies TS-HDS and FGFR3. Trials, record NCT03401073. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03401073
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- IVIg for Small Fiber Neuropathy With Autoantibodies TS-HDS and FGFR3
- NCT number
- NCT03401073
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Conditions
- Small Fiber Neuropathy, Idiopathic Peripheral Neuropathy
- Interventions
- Intravenous immunoglobulin, 0.9% Sodium Chloride
- First posted
- 2018-01-17
- Last updated
- 2023-09-13
- Results first posted
- 2023-09-13
- Limitations and caveats
This was a small pilot study that was underpowered to detect changes to secondary endpoints.~There was a 15% dropout. Despite several publications that note an association between TS-HDS and FGFR-3 autoantibodies in neuropathy, we do not have evidence for pathogenicity (supported by a non-insignificant number of patients excluded from the study with autoantibodies but without evidence of neuropathy). This too may have limited the potential treatment effect of immune globulin.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Change in Nerve Fiber Density Between Visits 1 and 8. | Visit 1 (time zero) and visit 8 (range of visit time 22-27 weeks after visit 1), thus a total of 22-27 weeks for the study (the range is provided to ensure final follow up is completed despite any conflicts with travel or holidays). | Difference in intra-epidermal nerve fiber density between visits 1 and 8 will be measured. Intra-epidermal nerve fiber density is a quantitative measure of the number of nerve fibers per millimeter. The outcome is the number of nerve fibers measured at visit 8 minus the number of nerve fibers measured at visit 1. A positive value indicates that nerve fiber density has increased (a better outcome), a negative value indicates that the nerve fiber density has decreased (a worse outcome). |
| Secondary | The Change in Neuropathic Pain Severity Between Visits 1 and 8. | Visit 1 (time zero) and visit 8 (range of visit time 22-27 weeks after visit 1), thus a total of 22-27 weeks for the study (the range is provided to ensure final follow up is completed despite any conflicts with travel or holidays). | The visual analog scale (VAS) of pain allows for quantification of neuropathic pain. The VAS pain scale depicts a line ranging from 0 (no pain) to 10 (worst possible pain). The scale is ordinal ranging from 0-10. The difference in pain between visit 1 and visit 8 (pain measured at visit 8 subtracted from the score at visit 1) is the range. Positive values indicate an increase in pain (worse outcome), negative values indicate an improvement in pain (better outcome). |
| Secondary | 2) The Difference in Change Between Quantified Utah Early Neuropathy Examination Scores, Between Treatment and Placebo Groups Between Visits 1 and 8. | Visit 1 (time zero) and visit 8 (range of visit time 22-27 weeks after visit 1), thus a total of 22-27 weeks for the study (the range is provided to ensure final follow up is completed despite any conflicts with travel or holidays). | The Utah Early Neuropathy Scale (UENS) was developed specifically to detect and quantify early small-fiber sensory neuropathy and to recognize modest changes in sensory severity and distribution. The UENS scale ranges from 0 (no neuropathy) to 42 (severe small fiber neuropathy). The outcome measure is the UENS score from Visit 8 minus the UENS score at visit 1. The difference in the two scores indicates the change in neuropathy severity. A positive value indicates that neuropathy has worsened over the course of the study, a negative value indicates that neuropathy has improved over the course of the study. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Change in Nerve Fiber Density Between Visits 1 and 8. | Visit 1 (time zero) and visit 8 (range of visit time 22-27 weeks after visit 1), thus a total of 22-27 weeks for the study (the range is provided to ensure final follow up is completed despite any conflicts with travel or holidays). | The 17 study completers were analyzed as part of the final results. | fibers/mm | MEAN |
| SECONDARY | The Change in Neuropathic Pain Severity Between Visits 1 and 8. | Visit 1 (time zero) and visit 8 (range of visit time 22-27 weeks after visit 1), thus a total of 22-27 weeks for the study (the range is provided to ensure final follow up is completed despite any conflicts with travel or holidays). | units on a scale | MEAN | |
| SECONDARY | 2) The Difference in Change Between Quantified Utah Early Neuropathy Examination Scores, Between Treatment and Placebo Groups Between Visits 1 and 8. | Visit 1 (time zero) and visit 8 (range of visit time 22-27 weeks after visit 1), thus a total of 22-27 weeks for the study (the range is provided to ensure final follow up is completed despite any conflicts with travel or holidays). | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Change in Nerve Fiber Density Between Visits 1 and 8. | 0.9% Sodium Chloride | 0.5 | Standard Deviation 0.8 | fibers/mm | |
| The Change in Nerve Fiber Density Between Visits 1 and 8. | Intravenous Immunoglobulin | 0.6 | Standard Deviation 0.6 | fibers/mm | |
| The Change in Neuropathic Pain Severity Between Visits 1 and 8. | 0.9% Sodium Chloride | -1.7 | Standard Deviation 0.9 | units on a scale | |
| The Change in Neuropathic Pain Severity Between Visits 1 and 8. | Intravenous Immunoglobulin | -1.9 | Standard Deviation 2.6 | units on a scale | |
| 2) The Difference in Change Between Quantified Utah Early Neuropathy Examination Scores, Between Treatment and Placebo Groups Between Visits 1 and 8. | 0.9% Sodium Chloride | -3.0 | Standard Deviation 5.8 | units on a scale | |
| 2) The Difference in Change Between Quantified Utah Early Neuropathy Examination Scores, Between Treatment and Placebo Groups Between Visits 1 and 8. | Intravenous Immunoglobulin | -1.8 | Standard Deviation 3.9 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 0.9% Sodium Chloride | 10 | |
| Overall Study | STARTED | Intravenous Immunoglobulin | 10 | |
| Overall Study | COMPLETED | 0.9% Sodium Chloride | 9 | |
| Overall Study | COMPLETED | Intravenous Immunoglobulin | 8 | |
| Overall Study | NOT COMPLETED | 0.9% Sodium Chloride | 1 | |
| Overall Study | NOT COMPLETED | Intravenous Immunoglobulin | 2 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Infusion reaction | Product Issues | 0.9% Sodium Chloride | 9 | 10 | 25 |
| other | Infusion reaction | Product Issues | Intravenous Immunoglobulin | 8 | 10 | 22 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 0.9% Sodium Chloride | 0 | 10 |
| Total, all-cause mortality | Intravenous Immunoglobulin | 0 | 10 |
| Total, other adverse events | 0.9% Sodium Chloride | 9 | 10 |
| Total, other adverse events | Intravenous Immunoglobulin | 8 | 10 |
| Total, serious adverse events | 0.9% Sodium Chloride | 0 | 10 |
| Total, serious adverse events | Intravenous Immunoglobulin | 0 | 10 |
Source ClinicalTrials.gov
Papers15
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 0.9% Sodium Chloride vs Intravenous Immunoglobulin: deaths from any cause | Trial comparisons |
| 0.9% Sodium Chloride vs Intravenous Immunoglobulin: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03401073
GET https://conductscience.org/api/trials/v1/NCT03401073/registered