Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039988
Status:
COMPLETED
Last Update Posted:
2016-09-22
First Post:
2002-06-18
Brief Title:
Treatment of Multiple Sclerosis With Copaxone and Albuterol
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Treatment of Multiple Sclerosis With Copaxone Glatiramer Acetate and Albuterol
Status:
COMPLETED
Status Verified Date:
2016-09
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:
The purpose of this study is to determine the effects of glatiramer acetate Copaxone alone compared to Copaxone plus albuterol in patients with Multiple Sclerosis MS
MS is thought to be an autoimmune disease of the central nervous system Certain white blood cells of the immune system become abnormally active and mistakenly attack the myelin of nerve fibers Myelin is a fatty sheath that surrounds nerve fibers and insulates the nerve like insulation around an electrical wire Without proper myelin insulation messages sent between the brain and other parts of the body may be confused or fail completely Damage to myelin causes the symptoms of MS The most common form of MS is known as relapsing-remitting RR where partial or total recovery occurs after attacks Four therapies are currently approved for the treatment of MS These therapies however are only moderately effective and can cause undesirable side effects For this reason there is a need to find new therapies that have minimal side effects and may stop the disease from getting worse
MS is thought to be an autoimmune disease of the central nervous system Certain white blood cells of the immune system become abnormally active and mistakenly attack the myelin of nerve fibers Myelin is a fatty sheath that surrounds nerve fibers and insulates the nerve like insulation around an electrical wire Without proper myelin insulation messages sent between the brain and other parts of the body may be confused or fail completely Damage to myelin causes the symptoms of MS The most common form of MS is known as relapsing-remitting RR where partial or total recovery occurs after attacks Four therapies are currently approved for the treatment of MS These therapies however are only moderately effective and can cause undesirable side effects For this reason there is a need to find new therapies that have minimal side effects and may stop the disease from getting worse
Detailed Description:
MS is a chronic inflammatory disease of the central nervous system characterized by focal T cell and macrophage infiltrates that lead to demyelination and loss of neurologic function Four therapies are currently approved for the treatment of MS Three of these are approved for the treatment of patients with the relapsing-remitting RR form of MS in which patients have clinical exacerbations followed by partial or complete recovery of function These treatments are only modestly effective and are associated with significant toxicity often causing patients to delay therapy for significant lengths of time Thus there is a need to find therapies with low toxicities that can be administered early during the disease course with the potential for arresting the disease
During the pre-treatment phase patients undergo neurological exams including the extended disability status scale EDSS Ambulation Index AI disease steps DS scale MS functional composite score PASAT 9 hole peg test and the 25 foot walking time A 12-lead electrocardiogram EKG and chest x-ray are performed Serum chemistry is assessed as well as electrolyte and thyroid stimulating hormone TSH levels A brain MRI with and without gadolinium urinalysis and urine pregnancy test for women of reproductive potential are performed Blood is collected for mechanistic studies In the treatment phase patients are assigned randomly to 1 of 2 study arms
Arm 1 Copaxone plus placebo Arm 2 Copaxone plus albuterol At the treatment visits blood is collected and neurological exams and a brain MRI are performed A pregnancy test is administered to women of reproductive potential Neurological exams are performed every 6 months MRIs are performed at baseline Year 1 and Year 2 At the end of the study patients have a complete physical exam a neurological exam and a brain MRI
During the pre-treatment phase patients undergo neurological exams including the extended disability status scale EDSS Ambulation Index AI disease steps DS scale MS functional composite score PASAT 9 hole peg test and the 25 foot walking time A 12-lead electrocardiogram EKG and chest x-ray are performed Serum chemistry is assessed as well as electrolyte and thyroid stimulating hormone TSH levels A brain MRI with and without gadolinium urinalysis and urine pregnancy test for women of reproductive potential are performed Blood is collected for mechanistic studies In the treatment phase patients are assigned randomly to 1 of 2 study arms
Arm 1 Copaxone plus placebo Arm 2 Copaxone plus albuterol At the treatment visits blood is collected and neurological exams and a brain MRI are performed A pregnancy test is administered to women of reproductive potential Neurological exams are performed every 6 months MRIs are performed at baseline Year 1 and Year 2 At the end of the study patients have a complete physical exam a neurological exam and a brain MRI
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 |
|---|---|---|---|
| ACE Study AMS01 | None | None | None |