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NCT03401073 · ClinicalTrials.gov registry record · Phase 2
IVIg for Small Fiber Neuropathy With Autoantibodies TS-HDS and FGFR3
A Phase 2 study, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT03401073: Completed Phase 2 study, sponsored by Beth Israel Deaconess Medical Center.
NCT03401073 is a Phase 2 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03401073, a Phase 2 study, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
The objective of this study is to develop a rationale for the selective treatment of small fiber neuropathy with immune globulin (IVIG) in the appropriate patients. The investigators hypothesize that individuals with auto-antibodies targeting neuronal antigens (TS-HDS and FGFR3) and confirmed evidence of small fiber neuropathy (by skin biopsy analysis of intra-epidermal nerve fiber density) will have an improvement in both nerve fiber density and pain after treatment with immune globulin. The co-primary endpoints will be a change in neuropathic pain (by VAS pain score) and a change in intra-epidermal nerve fiber density (by punch skin biopsy). The data gained from this pilot study will establish a rationale, with an appropriate screening test, for the use of immune globulin for the treatment of small fiber neuropathy.
Primary Outcome
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).
Interventions
- DRUG Intravenous immunoglobulin
- DRUG 0.9% Sodium Chloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-09-01 |
| Est. Completion | 2022-02-01 |
| Phase | Phase 2 |
What the finished NCT03401073 record still lists
NCT03401073 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Intravenous immunoglobulin is the first listed.
NCT03401073 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03401073 about?
NCT03401073 is a clinical study titled "IVIg for Small Fiber Neuropathy With Autoantibodies TS-HDS and FGFR3". The objective of this study is to develop a rationale for the selective treatment of small fiber neuropathy with immune globulin (IVIG) in the appropriate patients. The investigators hypothesize that individuals with auto-antibodies targeting neuronal antigens (TS-HDS and FGFR3) and confirmed evide...
What is the current status of trial NCT03401073?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2018-09-01. Estimated completion is 2022-02-01.
What interventions are being tested in trial NCT03401073?
The interventions under investigation include: Intravenous immunoglobulin (DRUG), 0.9% Sodium Chloride (DRUG).
Who is sponsoring clinical trial NCT03401073?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03401073's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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