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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: Clinical Trial Phase 1 study, sponsored by Ohio State University.
NCT03701711 is a Phase 1 study that was terminated before completion, run by Ohio State University. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
the maximum tolerated dose (MTD) of lenalidomide
Interventions
- DRUG Lenalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-09-10 |
| Est. Completion | 2022-02-28 |
| Phase | Phase 1 |
Why NCT03701711 stopped before completion
NCT03701711 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which Lenalidomide is the first listed.
NCT03701711 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT03701711's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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