Ignite Creation Date:
2024-05-05 @ 7:21 PM
Last Modification Date:
2024-10-26 @ 9:47 AM
Study NCT ID:
NCT00654927
Status:
COMPLETED
Last Update Posted:
2012-03-02
First Post:
2008-04-04
Brief Title:
Open-Label Extension Study to Evaluate the Safety Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis
Sponsor:
Acorda Therapeutics
Organization:
Acorda Therapeutics
Study Overview
Official Title:
Phase 3 Open-Label Extension Study to Evaluate the Safety Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2012-01
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 this study is to evaluate the long-term safety tolerability and activity of Fampridine-SR in subjects with multiple sclerosis who have previously participated in either an Acorda Therapeutics or an Elan Corporation sponsored protocol Subjects are eligible regardless of whether they received active drug or placebo during their participation in the previous study
Detailed Description:
Under the original protocol patients were to have their treatment dose titrated upwards from a starting dose of 10mg bid to 15mg bid and then to a stable maintenance dose of 20mg bid The protocol was subsequently revised to lower the maximum maintenance dose In the most current protocol all patients were down-titrated to 10mg bid and maintained at this dose for the greater part of the duration of the study
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 over a long period of time
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 over a long period of time
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