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NCT00001550 · ClinicalTrials.gov registry record · Phase 1
Intravenous Immunoglobulin (IVIg) for the Treatment of Stiff-Man Syndrome (SMS)
A Phase 1 study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT00001550 is a Phase 1 study that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 20 participants.
The verdict
NCT00001550, a Phase 1 study, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
Stiff-man Syndrome (SMS) is a chronic, progressive disorder of the nervous system. It is associated with painful muscle spasms and rigidity involving muscles of the limbs, trunk, and neck. The cause of the disease is unknown, but researchers believe it may be a result of an autoimmune process. Patients with Stiff-man Syndrome may produce antibodies that attack enzymes required for the normal function of the nervous system. Steroids, plasmapheresis, and intravenous immunoglobulin (IVIg) have been given to relieve some of the symptoms of Stiff-man Syndrome. However, none of these therapies have proven to be significantly effective. This study will attempt to determine the effectiveness of intravenous immunoglobulin (IVIg) for the treatment of Stiff-mann Syndrome. Patients participating in this study will be divided into two groups. Group one will receive 2 injections of IVIg once a month for three months. Group two will receive 2 injections of placebo "inactive sterile water" once a month for three months. Following the three months of treatment, group one will begin taking the placebo and group two will begin taking IVIg for an additional 3 months. The drug will be considered effective if patients receiving it experience a significant improvement in muscle function, mobility, and stiffness.
Interventions
- DRUG IVIg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 1996-04 |
| Est. Completion | 2002-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001550
The ClinicalTrials.gov registry entry for NCT00001550 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 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 1 intervention - of which IVIg is the first listed.
NCT00001550 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001550 about?
NCT00001550 is a clinical study titled "Intravenous Immunoglobulin (IVIg) for the Treatment of Stiff-Man Syndrome (SMS)". Stiff-man Syndrome (SMS) is a chronic, progressive disorder of the nervous system. It is associated with painful muscle spasms and rigidity involving muscles of the limbs, trunk, and neck. The cause of the disease is unknown, but researchers believe it may be a result of an autoimmune process. Patie...
What is the current status of trial NCT00001550?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 1996-04. Estimated completion is 2002-05.
What interventions are being tested in trial NCT00001550?
The interventions under investigation include: IVIg (DRUG).
Who is sponsoring clinical trial NCT00001550?
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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