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NCT02915263 · ClinicalTrials.gov registry record · Phase 2
The Efficacy Of Intravenous Immunoglobulin Therapy In Treatment Induced Neuropathy Of Diabetes
A Phase 2 study, sponsored by Beth Israel Deaconess Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT02915263: Clinical Trial Phase 2 study, sponsored by Beth Israel Deaconess Medical Center.
NCT02915263 is a Phase 2 study that was terminated before completion, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02915263, a Phase 2 study, was terminated before completion, sponsored by Beth Israel Deaconess Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
The goal of this pilot study is to obtain preliminary data on the magnitude of the treatment effect of IVIG on the neuropathic pain and neuropathy severity associated with treatment induced neuropathy (TIND). The investigators hypothesize that immune globulin, administered intravenously (IVIG), will reduce the pain associated with treatment induced neuropathy and reduce the neuropathy severity. Treatment induced neuropathy in diabetes, is an iatrogenic complications of diabetes. The preliminary data will be used to power a larger treatment trial, and to aid the understanding of the mitigating factors in the treatment response.
Primary Outcome
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 7 weeks (final evaluation) minus the UENS score from the baseline visit. A positive value indicates that neuropathy worsened over the course of the trial (a worse outcome), a n
Interventions
- DRUG 0.9% Sodium Chloride
- DRUG IGIV-C
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2017-09-11 |
| Est. Completion | 2022-02-01 |
| Phase | Phase 2 |
Why NCT02915263 stopped before completion
NCT02915263 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which 0.9% Sodium Chloride is the first listed.
NCT02915263 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02915263 about?
NCT02915263 is a clinical study titled "The Efficacy Of Intravenous Immunoglobulin Therapy In Treatment Induced Neuropathy Of Diabetes". The goal of this pilot study is to obtain preliminary data on the magnitude of the treatment effect of IVIG on the neuropathic pain and neuropathy severity associated with treatment induced neuropathy (TIND). The investigators hypothesize that immune globulin, administered intravenously (IVIG), wil...
What is the current status of trial NCT02915263?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2017-09-11. Estimated completion is 2022-02-01.
What interventions are being tested in trial NCT02915263?
The interventions under investigation include: 0.9% Sodium Chloride (DRUG), IGIV-C (DRUG).
Who is sponsoring clinical trial NCT02915263?
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 NCT02915263's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 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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