Compostions and methods for using aminopyridines
A kind of aminopyridine, the technology of composition, is applied in the composition and method field for aminopyridine application, can solve the problems such as inapplicability
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Embodiment 1
[0379] This example provides an embodiment of a method of using the sustained release 4-aminopyridine formulation of the present invention and responder analysis to treat a subject. This is a Phase 2, double-blind, placebo-controlled, parallel group, 20-week treatment study in 206 subjects diagnosed with multiple sclerosis. This study was designed to investigate the safety and efficacy of three dose levels of 4-aminopyridine-SR, namely 10 mg b.i.d., 15 mg b.i.d. and 20 mg b.i.d. in subjects with clinically established multiple sclerosis. The primary efficacy endpoint was the increase in walking speed relative to baseline during a timed 25-foot walk. Secondary efficacy measurements include hand-tested muscle strength of the lower extremities in the four lower extremity muscle groups (hip flexors, knee flexors, knee extensors, and ankle dorsi flexors); 9-hole column test and simultaneous auditory series addition test (PASAT 3 "); Ashworth score for spasticity; Spasticity frequen...
Embodiment 2
[0451] Phase 3 trial of sustained-release oral 4-aminopyridine in multiple sclerosis
[0452] The currently available treatments for multiple sclerosis (MS) are considered immunomodulatory. Fampridine (4-aminopyridine) is a novel type of therapy that directly targets the nervous system rather than the immune system, and the therapy modifies the function of axons demyelinated by the disease. The previous Phase 3 trial (MS-203) showed that treatment with sustained-release tablets of 4-aminopyridine at a dose of 10 mg twice a day improved the walking ability of people with multiple sclerosis (MS), and this Provides clinically significant therapeutic benefits.
[0453] A series of clinical studies have shown that treatment with 4-aminopyridine is associated with the improvement of many neurological functions affected by MS, but most of these earlier studies do not allow unbiased evaluation of safety and efficacy . More recently, a series of four clinical trials including two Phase 3...
Embodiment 3
[0519] Sustained release of 4-aminopyridine improves walking speed across a wide range of baseline defects: pooled data from three placebo-controlled studies in patients with multiple sclerosis.
[0520] This example examines the extent to which the timed 25-foot walking (T25FW) speed of patients with multiple sclerosis (MS) treated with 4-aminopyridine-SR 10 mg b.i.d. or placebo in three studies improved from baseline.
[0521] Design / Methods: All patients from MS-F202, MS-F203, and MS-F204 were included in the pooled analysis. Patients with clinically established multiple sclerosis were randomly assigned to 4-aminopyridine-SR 10 mg b.i.d. or placebo for up to 14 weeks. The primary efficacy variable is defined as a timed 25-foot walk (T25FW) for at least 3 double-blind efficacy visits at least 3 times faster than any maximum walking speed for 5 non-treatment visits, and is expected to be determined for MS -F203 and MS-F204 and retrospectively used in MS-F202. Average walking spe...
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