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NCT00050245 · ClinicalTrials.gov registry record · Phase 2
Rituximab to Treat Neuropathy With Anti-MAG Antibodies
A Phase 2 study of Polyneuropathies, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT00050245: Completed Phase 2 study of Polyneuropathies, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
NCT00050245 is a Phase 2 study of Polyneuropathies that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 30 participants, below the 433-participant average among 4 other Polyneuropathies trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00050245, a Phase 2 study of Polyneuropathies, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will test the safety and effectiveness of the drug Rituximab in treating a nerve disease called MGUS (also known as neuropathy with anti-MAG antibodies). Patients with MGUS have an abnormal protein called monoclonal IgM immunoglobulin that attacks the myelin sheath (protective coating) of nerves, causing them to not function properly. The disease affects the nerves in the legs or arms, and patients have numbness, tingling, muscle weakness, and unsteady gait. There are no adequate treatments. Immunosuppressive drugs or human immunoglobulin infusions can produce mild and transient improvement, but the benefits of these therapies are not significant. The abnormal immunoglobulin protein in MGUS is produced by white cells called B lymphocytes. Rituximab is approved to treat B cell lymphomas. Also, the drug showed promise in a recent study of patients with demyelinating neuropathy associated with production of antibodies from B lymphocytes directed against certain nerve proteins. Although the number of patients treated with Rituximab was small, the drug was well tolerated and caused significant improvement in several of the patients. Patients 25 years of age and older with MGUS may be eligible for this 2-year study. Candidates will be screened with a medical history, physical and neurological examinations, and blood tests. Participants will be randomly assigned to receive intravenous (through a vein) infusions of either Rituximab or placebo (a solution that looks like Rituximab but has no active ingredient) once a week for 4 consecutive weeks. In addition, they will undergo the following tests and procedures: * Monthly follow-up visits following Rituximab treatment for repeat physical and neurological examinations, blood tests, muscle strength measurements, and review of signs and symptoms. * Two sessions of lymphapheresis, one at the beginning of the study and one a year later-to collect lymphocytes. For this procedure, whole blood is drawn through a needl
Conditions Studied
Interventions
- DRUG Rituximab
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2002-11-27 |
| Est. Completion | 2007-10-17 |
| Phase | Phase 2 |
What the finished NCT00050245 record still lists
NCT00050245 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 433-participant average among 4 other Polyneuropathies trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Polyneuropathies appearing as the primary indexed condition, and to 1 intervention - of which Rituximab is the first listed.
NCT00050245 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00050245 about?
NCT00050245 is a clinical study titled "Rituximab to Treat Neuropathy With Anti-MAG Antibodies". This study will test the safety and effectiveness of the drug Rituximab in treating a nerve disease called MGUS (also known as neuropathy with anti-MAG antibodies). Patients with MGUS have an abnormal protein called monoclonal IgM immunoglobulin that attacks the myelin sheath (protective coating) of...
What is the current status of trial NCT00050245?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2002-11-27. Estimated completion is 2007-10-17.
What conditions does trial NCT00050245 study?
This clinical trial studies the following conditions: Polyneuropathies.
What interventions are being tested in trial NCT00050245?
The interventions under investigation include: Rituximab (DRUG).
Who is sponsoring clinical trial NCT00050245?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00050245 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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