Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03701711 · ClinicalTrials.gov registry record · Phase 1
Lenalidomide in Anti-MAG Neuropathy: Phase 1b Study
A Phase 1 study, sponsored by Ohio State University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT03701711 is a Phase 1 study that was terminated before completion, run by Ohio State University. The registered enrollment target is 11 participants.
The verdict
NCT03701711, a Phase 1 study, was terminated before completion, sponsored by Ohio State University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
Anti-myelin-associated glycoprotein (MAG) is a rare autoimmune disorder of the peripheral nerves that presents with weakness, gait imbalance, and loss of sensation. It almost always occurs in the setting of excess protein buildup in the body in the form of immunoglobulin monoclonal (IgM) gammopathy. Anti-MAG neuropathy currently has no established therapies. It is diagnosed through blood tests (anti-MAG and IgM), nerve conduction studies (which showed marked velocity slowing), and clinical exam findings.The efficacy of lenalidomide has been demonstrated in anti-MAG peripheral neuropathy with two separate dosing regimens: 25mg on days 1-21 of each 28 day cycle in conjunction with oral dexamethasone 20mg/day on days 1-4 of each cycle as well as at 5mg on days 1-21 of each cycle without oral dexamethasone. This phase 1 study aims to determine the maximum tolerated dose (MTD) of Lenalidomide in patients with anti-MAG neuropathy. We will explore preliminary efficacy and postulate that this drug is effective in this subset of patients, using preselected, specifically tailored outcome measures that encompass quality of life, neurologic function, serum protein levels, and focused measures of proprioception.
Interventions
- DRUG Lenalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-09-10 |
| Est. Completion | 2022-02-28 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03701711
The ClinicalTrials.gov registry entry for NCT03701711 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lenalidomide is the first listed.
NCT03701711 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03701711 about?
NCT03701711 is a clinical study titled "Lenalidomide in Anti-MAG Neuropathy: Phase 1b Study". Anti-myelin-associated glycoprotein (MAG) is a rare autoimmune disorder of the peripheral nerves that presents with weakness, gait imbalance, and loss of sensation. It almost always occurs in the setting of excess protein buildup in the body in the form of immunoglobulin monoclonal (IgM) gammopathy....
What is the current status of trial NCT03701711?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2018-09-10. Estimated completion is 2022-02-28.
What interventions are being tested in trial NCT03701711?
The interventions under investigation include: Lenalidomide (DRUG).
Who is sponsoring clinical trial NCT03701711?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.