Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001287
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Intravenous Immunoglobulin IVIg for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy CIDP
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 in Chronic Inflammatory Demyelinating Polyneuropathy CIDP
Status:
COMPLETED
Status Verified Date:
2000-02
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:
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
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
Detailed Description:
Chronic inflammatory demyelinating polyneuropathy CIDP is a slowly progressive disabling neuropathy characterized by subacute onset of muscle weakness distal sensory deficit elevated spinal fluid protein and slow nerve conduction velocity with or without conduction block A monoclonal gammopathy is at times present in the serum of some patients Because immune-mediated mechanisms against peripheral nerve myelin are thought to be primarily responsible for the clinical manifestations of CIDP the treatment of choice is with corticosteroids plasmapheresis or immunosuppressive drugs Although many patients initially respond to these agents a large number of them become resistant or develop unacceptable side effects that necessitate their discontinuation The need for a more effective and safe immunotherapy in CIDP patients prompted the present study using high-dose intravenous immunoglobulin IVIg IVIg is an immunomodulating agent which has been recently shown to be effective and safe in the treatment of a number of patients with immune-related neuromuscular diseases
This is a double blind randomized placebo controlled trial involving 60 patients half of which will receive IVIg and the other half placebo D5W Because IVIg is prohibitively expensive a controlled trial is needed to provide convincing evidence of efficacy and ensure that the benefit is not due to spontaneous improvement or to observer bias The dose of IVIg is 2 GMKg divided into two daily doses administered monthly for six months The drug will be considered effective if patients experience an increase of more than 25 in their baseline muscle strength Muscle strength will be assessed with a series of objective dynamometric measurements performed before and after each monthly infusion
This is a double blind randomized placebo controlled trial involving 60 patients half of which will receive IVIg and the other half placebo D5W Because IVIg is prohibitively expensive a controlled trial is needed to provide convincing evidence of efficacy and ensure that the benefit is not due to spontaneous improvement or to observer bias The dose of IVIg is 2 GMKg divided into two daily doses administered monthly for six months The drug will be considered effective if patients experience an increase of more than 25 in their baseline muscle strength Muscle strength will be assessed with a series of objective dynamometric measurements performed before and after each monthly infusion
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 |
|---|---|---|---|
| 91-N-0039 | None | None | None |