Compositions and methods for extended therapy with aminopyridines
A technology of aminopyridine and composition, applied in the field of treating multiple sclerosis, capable of solving problems such as inapplicability
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Embodiment 1
[0380] This example provides an embodiment of a method of treating a subject with a sustained release 4-aminopyridine formulation of the invention and a responder assay. This was 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, 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 from baseline in walking speed during a timed 25-foot walk. Secondary measures of strength included manual testing of lower extremity strength in four lower extremity muscle groups (hip flexors, knee flexors, knee extensors, and ankle dorsiflexors); ”); Ashworth score for spasticity; spasticity frequency / severity score; and Clinician (CGI) and Subject (SGI) Global Impression, Subject Global Impression (SGI), Mul...
Embodiment 2
[0452] Phase 3 trial of sustained-release oral 4-aminopyridine in multiple sclerosis
[0453] Currently available treatments for multiple sclerosis (MS) are thought to be immunomodulatory. Fampridine (4-aminopyridine) is a novel class of therapy that directly targets the nervous system rather than the immune system, modifying the function of axons demyelinated by the disease. A previous phase 3 trial (MS-203) showed that treatment with sustained-release tablets of 4-aminopyridine at a dose of 10 mg twice daily improved walking ability in people with multiple sclerosis (MS), and this Provides clinically meaningful therapeutic benefit.
[0454] A series of clinical studies have shown that treatment with 4-aminopyridine is associated with improvements in many of the neurological functions affected by MS, but most of these earlier studies did not allow for an unbiased assessment of safety and efficacy . More recently, a series of four clinical trials (this study is the second o...
Embodiment 3
[0520] Sustained-release 4-aminopyridine improves walking speed across a wide range of baseline deficits: pooled data from three placebo-controlled studies in patients with multiple sclerosis.
[0521] This example examines the extent of improvement from baseline in timed 25-foot walk (T25FW) speed in patients with multiple sclerosis (MS) treated with 4-aminopyridine-SR 10 mg b.i.d. or placebo in three studies.
[0522]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 was defined as timed 25-foot walk (T25FW) walking speed for at least 3 of 4 double-blind efficacy visits faster than any maximum walking speed of 5 non-treatment visits and was determined prospectively for MS -F203 and MS-F204 and retrospectively for MS-F202. Mean walking speed (WS) over f...
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