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Use of laquinimod for reducing fatigue, improving functional status, and improving quality of life in multiple sclerosis patients

A technology for multiple sclerosis, functional status, in the field of use of laquinimod to reduce fatigue, improve functional status and improve quality of life in multiple sclerosis patients, addressing unidentified issues

Inactive Publication Date: 2013-08-21
TEVA PHARMA IND LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

(EMEA Guidelines, 2006) Thus, relapse rate and disability progression are currently accepted indicators of treatment effectiveness in RRMS, but for laquinimod these indicators had not been identified earlier

Method used

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  • Use of laquinimod for reducing fatigue, improving functional status, and improving quality of life in multiple sclerosis patients
  • Use of laquinimod for reducing fatigue, improving functional status, and improving quality of life in multiple sclerosis patients
  • Use of laquinimod for reducing fatigue, improving functional status, and improving quality of life in multiple sclerosis patients

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0100] Example 1: Clinical Trial (Phase III) - Evaluation of Oral Laquinimod in Prevention of MS Progression

[0101] Conducted a multinational (24 countries), multicenter (approximately 139 sites), randomized, double-blind, parallel-group, placebo-controlled clinical trial ("ALLEGRO" or MS-LAQ-301) to evaluate Efficacy, safety and tolerability of daily oral administration of 0.6 mg laquinimod for a period of 24 months in individuals with recurrent multiple sclerosis (RRMS).

[0102] One thousand one hundred and six (1106) patients were randomized equally to 0.6 mg laquinimod or placebo and treated in a double-blind fashion with baseline characteristics balanced between the groups. The primary endpoint of the study was the number of relapses identified during the double-blind treatment period, which corresponds to the annualized relapse rate (ARR - number of relapses divided by total exposure for all patients). Secondary endpoints included disability as measured by change i...

example 2

[0306] Example 2: Clinical Trial (Phase III) - and laquinimod benefit-risk assessment

[0307] A multinational, multicenter, randomized, parallel group clinical trial ("BRAVO") was conducted in individuals with RRMS. BRAVO was conducted in a double-blind and rater-blinded design to evaluate laquinimod versus placebo and interferon beta-1a Efficacy, safety and tolerability of the reference group. The study also aimed to administer oral laquinimod versus injectable interferon beta-1a Comparative benefit / risk assessments between.

[0308] The primary objective of this study was to assess the efficacy of laquinimod at a daily dose of 0.6 mg in individuals with RRMS by measuring the number of relapses determined during the treatment period. Secondary objectives of this study included assessing the effect of laquinimod at a daily dose of 0.6 mg on disability accumulation by assessing MSFC scores at the end of the treatment period; To assess the effect of laquinimod at a ...

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Abstract

The subject invention provides methods for reducing or inhibiting progression of the level of fatigue in a multiple sclerosis human patient, for improving or inhibiting deterioration of the functional status of a multiple sclerosis human patient, and for improving or inhibiting deterioration of the general health of a multiple sclerosis human patient, comprising orally administering to the human patient laquinimod or a pharmaceutically acceptable salt thereof. The subject invention also provides a method for providing neuroprotection to a human subject, the method comprising orally administering to the human subject laquinimod or a pharmaceutically acceptable salt thereof.

Description

[0001] This application claims the benefit of U.S. Provisional Application No. 61 / 420,742, filed December 7, 2010, and U.S. Provisional Application No. 61 / 542,996, filed October 4, 2011, the entire contents of each of which are hereby incorporated by reference way incorporated into this article. [0002] Throughout this application, various publications are referred to by first author and year of publication. Full citations to these publications are presented in the References section. The disclosures of the publications cited in the References section are hereby incorporated by reference in their entirety into this application in order to more fully describe the state of the art as of the date of the invention described herein. technical field [0003] none Background technique [0004] Multiple sclerosis (MS) is a neurological disease that affects more than one million people worldwide. It is the most common cause of neurological disability in young and middle-aged adul...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/47
CPCA61K31/4704A61P25/00A61P25/28A61P3/02A61P35/00A61K31/47
Inventor 诺拉·塔克斯克丹·巴-佐哈尔迪娜·科夫勒
Owner TEVA PHARMA IND LTD
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