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Laquinimod for reducing thalamic damage in multiple sclerosis

一种多发性硬化症、丘脑的技术，应用在应用、杂环化合物有效成分、杀生剂等方向，能够解决拉喹莫德作用机制未被充分了解等问题

Inactive Publication Date: 2016-01-20
TEVA PHARMA IND LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] The mechanism of action of laquinimod is not well understood

Method used

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  • Laquinimod for reducing thalamic damage in multiple sclerosis
  • Laquinimod for reducing thalamic damage in multiple sclerosis
  • Laquinimod for reducing thalamic damage in multiple sclerosis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0083] Example 1: Clinical Trial (Phase III)-Evaluation of Oral Laquinimod on the Progress of Prevention of MS

[0084] A multi-country (24 countries) multi-site (approximately 139 sites) randomized double-blind parallel group placebo-controlled clinical trial ("ALLEGRO" or MS-LAQ-301) was conducted to evaluate the daily oral administration of 0.6 mg laquine to individuals with RRMS Modd and lasted 24 months of efficacy, safety and tolerability.

[0085] 1106 patients were randomly assigned 0.6 mg laquinimod or placebo and treated in a double-blind manner, and baseline characteristics were balanced among the groups. The primary endpoint of the study is the number of confirmed recurrences during double-blind treatment, which corresponds to the annual recurrence rate (ARR-the number of recurrences divided by the total number of exposures for all patients). Secondary endpoints included the degree of disability, the cumulative number of gadolinium enhancement (GdE), and new / expanded ...

Embodiment 2

[0192] Example 2: ALLEGRO secondary study

[0193] Using multiple MRI techniques sensitive to irreversible tissue damage in white matter (WM) and gray matter (GM), multiple ALLEGRO secondary studies were performed to further explore the potential neuroprotective effects of laquinimod shown in the ALLERO trial.

[0194] method

[0195] WM, GM and thalamic volume analysis.

[0196] WM, GM, and thalamic volume were obtained from 3DT1-weighted images at baseline and at 12 and 24 months. Patients who were at baseline and had at least one effective scheduled post-baseline MRI were included in this analysis. Patients with thalamic lesions at baseline and valid post-baseline MRI were included in the analysis of thalamic lesions.

[0197] Evaluation of new T2 lesions with gadolinium enhancement (GdE) and permanent black hole (PBH)

[0198] The ALLEGRO subgroup of patients included the "frequent MRI" group used for PBH analysis; these patients had MRIs taken at 3, 6, 12, and 24 months. Patie...

Embodiment 3

[0241] Example 3: Evaluation of oral laquinimod in the treatment of tremor and spasm

[0242] It has been proven that spasms or tremors can be caused by damage to the thalamus, and stimulation of the thalamus is beneficial in treating tremors and spasms.

[0243] The laquinimod-containing composition described herein is administered to an individual suffering from tremor. The administration of the composition is effective to suppress the tremor of the individual.

[0244] The laquinimod-containing composition described herein is administered to an individual suffering from tremor. The administration of the composition is effective for reducing the tremor of the individual.

[0245] The laquinimod-containing composition described herein is administered to individuals suffering from cramps. The administration of the composition is effective in suppressing the spasm of the individual.

[0246] The laquinimod-containing composition described herein is administered to individuals sufferi...

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Abstract

This invention provides methods for inhibiting or reducing thalamic damage in a subject comprising administering to the subject an amount of laquinimod, wherein the subject is a human patient afflicted with a form of multiple sclerosis or presenting a clinically isolated syndrome who has been determined to have thalamic damage at baseline, a subject afflicted with a disease or disorder other than a form of multiple sclerosis or a clinically isolated syndrome, or a subject not afflicted with a form of multiple sclerosis or a presenting clinically isolated syndrome, and laquinimod and laquinimod pharmaceutical compositions for use thereof. This invention also provides methods for inhibiting or reducing tremor or spasticity in a subject afflicted by tremor or spasticity, comprising administering to the subject an amount of laquinimod, and laquinimod and laquinimod pharmaceutical compositions for use thereof.

Description

Technical field [0001] This application claims the priority of the U.S. Provisional Patent Application No. 61 / 713256 filed on October 12, 2012, the entire disclosure of which is incorporated herein by reference. [0002] Various publications are cited in this application based on the first author and publication year. The complete citation information of these publications is listed in the reference section immediately before the claims. The cited documents and the disclosures in the publications and references section are incorporated into this application by reference in their entirety in order to more fully illustrate the prior art prior to the date of the invention described herein. Background technique [0003] Multiple sclerosis (MS) is a neurological disease that affects more than one million people worldwide. It is the most common cause of neurological disability among young and middle-aged people, and has important physical, psychological, social and economic impacts on ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A01N43/44A61K31/44
CPCA61K31/4704A61P25/00A61P25/04A61P25/08A61P25/14A61P25/18A61P25/22A61P25/24A61P25/28A61K9/0053
Inventor 马西莫·菲莉比詹卡洛·科米玛丽亚·阿孙塔·罗卡
Owner TEVA PHARMA IND LTD
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