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NCT00091897 · ClinicalTrials.gov registry record · Phase 2
Rituximab to Treat Stiff Person Syndrome
A Phase 2 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT00091897 is a Phase 2 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 24 participants.
The verdict
NCT00091897, a Phase 2 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
This study will test whether rituximab (RITUXAN (Trademark)) can relieve symptoms of stiff person syndrome (SPS), a progressive disease that causes stiffness of the muscles and muscle spasms induced by unexpected noises, touches, or stressful events. People with SPS may have certain proteins in their blood called anti-GAD antibodies that may cause some of the symptoms of the disease. Rituximab, a drug approved to treat lymphomas, targets certain white blood cells that produce antibodies. This study will see if rituximab can also be effective in patients with SPS who have high anti-GAD antibodies. Patients between 25 and 80 years of age with SPS may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood tests. Participants undergo the following tests and procedures: * Rituximab or placebo treatment: Patients are randomly assigned to receive two infusions by vein of either rituximab or placebo (a look-alike solution with no active ingredient) 2 weeks apart. The infusions last from 3 to 4 hours, but may take as long as 16 hours if the rate must be slowed for any reason. Patients are followed monthly for up to 6 months and then every 2 months for up to 1 year after treatment. * Medical history and interview, physical and neurological examinations: Patients are questioned about their vaccination history, medical, surgical, and psychiatric history, exposure to environmental toxins or viruses, and family and social history, including habits and employment. * Blood drawing: Blood samples are collected before the two infusions and at all follow-up visits. * Apheresis: For this procedure, which is used to collect white blood cells, blood is collected through a needle in an arm vein, similar to donating blood. The blood flows from the vein through a catheter (plastic tube) into a machine that separates it into its components by centrifugation (spinning). The white cells are removed and the rest of the blood (red cells, pla
Interventions
- DRUG Rituximab
- DRUG rituximab or placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2004-09 |
| Est. Completion | 2009-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00091897
The ClinicalTrials.gov registry entry for NCT00091897 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Rituximab is the first listed.
NCT00091897 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00091897 about?
NCT00091897 is a clinical study titled "Rituximab to Treat Stiff Person Syndrome". This study will test whether rituximab (RITUXAN (Trademark)) can relieve symptoms of stiff person syndrome (SPS), a progressive disease that causes stiffness of the muscles and muscle spasms induced by unexpected noises, touches, or stressful events. People with SPS may have certain proteins in thei...
What is the current status of trial NCT00091897?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2004-09. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00091897?
The interventions under investigation include: Rituximab (DRUG), rituximab or placebo (DRUG).
Who is sponsoring clinical trial NCT00091897?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
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