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NCT00588822 · ClinicalTrials.gov registry record · Phase 2

Rituximab in Treating Patients With Peripheral Neuropathy Caused by Monoclonal Gammopathy of Undetermined Significance

A Phase 2 study, sponsored by Mayo Clinic.

Terminated
Registry status
Phase 2
Development phase
21
Enrollment target

NCT00588822: Clinical Trial Phase 2 study, sponsored by Mayo Clinic.

NCT00588822 is a Phase 2 study that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00588822, a Phase 2 study, was terminated before completion, sponsored by Mayo Clinic.

TERMINATED
Registry status
Phase 2
Development phase
21 participants
Enrollment target

Study Summary

This study was done to find out if the investigational medication, rituximab, could help relieve the symptoms of peripheral neuropathy (such as numbness \[abnormal protein in the blood\] and weakness of the lower and upper extremities) in people who have monoclonal gammopathy of undetermined significance and people with a symptomatic or smoldering Waldestrom macroglobulinemia. Rituximab is an antibody which attacks a particular type of white blood cell (B Cell). By targeting the B-cells which make the abnormal protein which is involved in causing the nerve trouble, it is hoped that damage to nerve fibers will be stopped and improvement will be allowed to proceed.

Primary Outcome

The Neuropathy Impairment Score \[previously called the Neurologic Disability Score (NDS)\] is derived from a neurologic examination obtained in a standard way by a specially trained neurologist. Decisions are based on the neurologist's judgment of what is normal considering site, age, sex, weight, height, and physical fitness. The instrument has 35 items, each ranked for left and right sides of the body; weakness is scored 0=normal, 1=25% disability, 2=50% disability, 3=75% disability and 4=100

Interventions

  • BIOLOGICAL Rituximab

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2005-01
Est. Completion 2011-02
Phase Phase 2
Mayo Clinic

2,844 total trials

Why NCT00588822 stopped before completion

NCT00588822 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).

The record links to 0 conditions, and to 1 intervention - of which Rituximab is the first listed.

NCT00588822 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00588822 about?

NCT00588822 is a clinical study titled "Rituximab in Treating Patients With Peripheral Neuropathy Caused by Monoclonal Gammopathy of Undetermined Significance". This study was done to find out if the investigational medication, rituximab, could help relieve the symptoms of peripheral neuropathy (such as numbness \[abnormal protein in the blood\] and weakness of the lower and upper extremities) in people who have monoclonal gammopathy of undetermined signifi...

What is the current status of trial NCT00588822?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2005-01. Estimated completion is 2011-02.

What interventions are being tested in trial NCT00588822?

The interventions under investigation include: Rituximab (BIOLOGICAL).

Who is sponsoring clinical trial NCT00588822?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00588822's enrollment target sits among peer trials

21 1794th of 2000 higher than 196 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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Source: ClinicalTrials.gov NCT00588822, the US trial registry maintained by the National Library of Medicine. NCT00588822 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.