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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 is a Phase 2 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 20 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03401073
The ClinicalTrials.gov registry entry for NCT03401073 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Deaconess Medical Center, which has 488 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Intravenous immunoglobulin is the first listed.
NCT03401073 reports 0 study locations.
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.
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