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NCT00030940 · ClinicalTrials.gov registry record
Cause, Development, and Progression of Stiff-Person Syndrome
A clinical trial, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- 40
- Enrollment target
NCT00030940 is a clinical trial that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 40 participants.
The verdict
NCT00030940 has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- 40 participants
- Enrollment target
Study Summary
This study will explore the role of various immune factors involved in producing the disease symptoms in stiff-person syndrome (SPS) and follow disease progression in patients. SPS is a progressive disease in which unexpected noises, touches or stressful events set off muscle spasms and stiffness. It is thought to be an autoimmune disease in which the body produces antibodies that attack certain healthy tissues. A better understanding of the disease may help researchers design new therapies. Patients of any age with SPS may be eligible for this study, except those who: * Lack of serum anti-GAD antibodies * Have very advanced disease that precludes traveling * Have severe cardiovascular, renal, or other end-organ-disease states Candidates will be screened with a medical history and physical and neurological examinations to confirm the diagnosis of SPS. After screening, those enrolled in the study will be followed at the NIH Clinical Center every 6 months for 2 years (months 6, 12, 18, and 24) to have the following tests and procedures: * Physical and neurological examinations and review of symptoms (every visit) * Blood draw for routine tests and for research studies (every visit) * Stiffness assessment (every visit) - Patients are asked a series of questions about their stiffness, which physicians rate according to the number of stiff areas (e.g., 0-no stiff areas; 1-stiffness of the lower trunk; 2-stiffness of the upper trunk, etc.). * Lymphapheresis (at the beginning of the study and at 12 months) - This is a procedure for collecting large quantities of white blood cells. A needle is placed in a vein in the arm. Blood flows from the vein through a plastic tube (catheter) into a machine that spins the blood, separating it into its components. The white blood cells (lymphocytes) are removed, and the rest of the blood-plasma, red cells and platelets-is returned to the body through a second needle placed in the other arm. * Electrophysiologic studies - These stud
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2002-02-11 |
| Est. Completion | 2007-12-28 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00030940
The ClinicalTrials.gov registry entry for NCT00030940 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 40 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 0 interventions.
NCT00030940 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00030940 about?
NCT00030940 is a clinical study titled "Cause, Development, and Progression of Stiff-Person Syndrome". This study will explore the role of various immune factors involved in producing the disease symptoms in stiff-person syndrome (SPS) and follow disease progression in patients. SPS is a progressive disease in which unexpected noises, touches or stressful events set off muscle spasms and stiffness. I...
What is the current status of trial NCT00030940?
This trial is currently completed. The enrollment target is 40 participants. The study started on 2002-02-11. Estimated completion is 2007-12-28.
Who is sponsoring clinical trial NCT00030940?
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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