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Low frequency glatiramer acetate therapy

A technique of glatiramer acetate, frequency, applied in the patient's field

Inactive Publication Date: 2012-08-01
YEDA RES & DEV CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, benign multiple sclerosis may develop into other forms of multiple sclerosis

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0097] A multinational, multicenter, randomized, phase III parallel-group study in individuals with relapsing-remitting multiple sclerosis (RRMS) to evaluate 40 mg / ml administered by subcutaneous injection three times per week in a double-blind design Efficacy, safety and tolerability of glatiramer acetate (GA) injection versus placebo.

[0098] method:

[0099] The study was designed to select injections on 3 days a week. Three injections are given every 7 days, and there must be at least one day between each injection.

[0100] Study Duration:

[0101] · Screening period: 1 month

[0102] ·Placebo Controlled (PC) period: 12 months, 40 mg / ml or matching placebo was administered by subcutaneous injection three times a week.

[0103] Open Label (OL) extension study: All subjects will continue to be treated with 40 mg / ml GA administered three times a week until this dose is marketed for the treatment of patients with relapsing remitting multiple sclerosis (RRMS) Or until de...

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Abstract

A method of alleviating a symptom of relapsing-remitting multiple sclerosis in a human patient suffering from relapsing-remitting multiple sclerosis or a patient who has experienced a first clinical episode and is determined to be at high risk of developing clinically definite multiple sclerosis comprising administering to the human patient three subcutaneous injections of a therapeutically effective dose of glatiramer acetate over a period of seven days with at least one day between every subcutaneous injection so as to thereby alleviate the symptom of the patient.

Description

[0001] This application claims priority to U.S. Provisional Application Nos. 61 / 337,612, filed February 11, 2010, and 61 / 274,687, filed August 20, 2009, each of which is incorporated herein by reference in its entirety middle. [0002] Throughout this application, various publications are cited by reference in their entirety. The disclosures of these publications in their entireties are incorporated by reference into this application in order to more fully describe the state of the art to which this invention pertains. Background technique [0003] Multiple Sclerosis (MS) is a debilitating, chronic central nervous system (CNS) disease. MS has also been classified as an autoimmune disease. Disease activity in MS can be monitored by magnetic resonance imaging (MRI) of the brain, accumulation of disability, and relapse rate and severity. [0004] There are five main forms of multiple sclerosis: [0005] 1) Benign multiple sclerosis: [0006] Benign multiple sclerosis is a re...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A01N37/12A01N37/44A61K31/195
CPCA61K38/02A61K38/16A61K9/0019A61K47/26A61P25/00A61K31/198A61P3/10A61K31/785A61K31/19A61K31/195A61K9/08A61K38/07
Inventor E·克林格尔
Owner YEDA RES & DEV CO LTD
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