Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001550
Status:
COMPLETED
Last Update Posted:
2006-07-14
First Post:
1999-11-03
Brief Title:
Intravenous Immunoglobulin IVIg for the Treatment of Stiff-Man Syndrome SMS
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Efficacy of High-Dose Intravenous Immunoglobulin Therapy in Patients With Stiff-Man Syndrome A Double-Blind Placebo-Controlled Trial
Status:
COMPLETED
Status Verified Date:
2002-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Stiff-man Syndrome SMS is a chronic disabling neurological disorder characterized by severe and painful axial and limb rigidity enhanced by anxiety sudden motion or external stimuli Although the cause of SMS is unknown immunologic mechanisms have been implicated on the basis of circulating autoantibodies in the patients serum and CSF against GAD glutamic acid decarboxylase the enzyme involved in the synthesis of GABA gamma aminobutyric acid Uncontrolled studies have also shown that plasmapheresis corticosteroids and high dose intravenous immunoglobulin IVIg are variably effective in improving the clinical symptoms of these patients The purpose of the present study is to demonstrate in a double blind placebo-control design the efficacy of IVIg in patients with SMS The effect of IVIg will be assessed with a series of objective measurements including muscle function mobility and stiffness Changes in the circulating anti-GAD antibodies will be also examined and their pathogenetic role in the cause of SMS will be determined If IVIg proves effective it will be a valuable tool in the treatment of these patients who are currently dependent on high doses of Valium up to 60-100 mg daily or steroids and experience significant side effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 96-N-0062 | None | None | None |