Intravenous Immunoglobulin (IVIg) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Status:
Completed
Trial end date:
2001-01-01
Target enrollment:
Participant gender:
Summary
Chronic Inflammatory Demylinating Polyneuropathy (CIDP) is an autoimmune condition affecting
the nervous system. Researchers believe the immune system begins attacking the cells covering
nerves called myelin. The destruction of myelin causes muscle weakness, loss of sensation,
abnormal levels of protein in the fluid surrounding the brain (CSF), and slowing of the
nervous system. The disease progresses slowly and disables patients suffering from it.
CIDP is treated with steroids, plasmapheresis, and immunosuppressive drugs. Many patients
initially respond to these treatments, but develop resistance to the therapy or experience
side effects causing the treatments to be stopped.
Researchers believe that intravenous immunoglobulin (IVIg) may provide patients with CIDP a
safer and more effective alternative to standard therapies for the disease. IVIg is a drug
that has been used successfully to treat other immune-related diseases of the nervous system.
However, because IVIg is so expensive, researchers believe it should first be proven
effective on a small group of patients.
The study will take 60 patients with CIDP and divide them 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 injection of 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 (>25%) in muscle strength.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)