Intravenous Immunoglobulin (IVIg) for the Treatment of Stiff-Man Syndrome (SMS)
Status:
Completed
Trial end date:
2002-05-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)