Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483652
Status:
COMPLETED
Last Update Posted:
2016-02-04
First Post:
2007-06-06
Brief Title:
Study of Fampridine-SR Tablets in Multiple Sclerosis Patients
Sponsor:
Acorda Therapeutics
Organization:
Acorda Therapeutics
Study Overview
Official Title:
Double-Blind Placebo-Controlled Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR 10 mg bid Bis in Die Twice Daily in Patients With Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2016-01
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 the study is to show that individuals treated with Fampridine-SR tablets are significantly more likely to have consistent improvements in their walking than those treated with placebo tablets
Detailed Description:
Multiple sclerosis MS is a disorder of the bodys immune system that affects the central nervous system CNS Normally nerve fibers carry electrical impulses through the spinal cord providing communication between the brain and the arms and legs In people with MS the fatty sheath that surrounds and insulates the nerve fibers called myelin deteriorates causing nerve impulses to be slowed or stopped As a result patients with MS may experience periods of muscle weakness and other symptoms such as numbness loss of vision loss of coordination paralysis spasticity mental and physical fatigue and a decrease in the ability to think andor remember These periods of illness may come exacerbations and go remissions Fampridine-SR is an experimental drug that has been reported to possibly improve muscle strength and walking ability for some people with MS This study will evaluate the effects and possible risks of taking Fampridine-SR in MS patients
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