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Novel therapeutic agent for amyotrophic lateral sclerosis(ALS) or disease attributable to ALS

A technology for lateral sclerosis and amyotrophy, which is applied in the fields of muscular system diseases, neuromuscular system diseases, drug combinations, etc., and can solve problems such as difficult to predict drug delivery methods

Inactive Publication Date: 2007-03-07
MITSUBISHI TANABE PHARMA CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is also necessary to study the possibility of side effects that have not been found before according to the change of the administration method, and it is difficult for those skilled in the art to predict the most suitable administration method

Method used

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  • Novel therapeutic agent for amyotrophic lateral sclerosis(ALS) or disease attributable to ALS
  • Novel therapeutic agent for amyotrophic lateral sclerosis(ALS) or disease attributable to ALS
  • Novel therapeutic agent for amyotrophic lateral sclerosis(ALS) or disease attributable to ALS

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0170] Example 1 According to ALSFRS-R (Revised ALS Functional Rating Scale, reference: cranial nerve, 53 (4): 346-355, 2001), the effectiveness evaluation after half a year of administration.

[0171] (30mg group)

[0172] For 5 ALS patients, 1 ampoule of "Radicut 30 mg injection" (containing edaravone 30 mg, manufactured and sold by Mitsubishi Pharmaceutical Co., Ltd.) was intravenously administered once a day for 30 minutes each time for 14 consecutive days. Days (Phase 1 administration). After the end of the first period, a 2-week observation (drug withdrawal) period was set, and then the same intravenous administration (administration in the second period) was performed for 10 days (no administration on Saturdays, Sundays, and holidays). Afterwards, repeat the same measures as in the second phase of administration 4 times (the third to sixth phases of administration).

[0173] (60mg group)

[0174] To 14 ALS patients, 2 ampoules of the above-mentioned "Radicut 30 mg in...

Embodiment 2

[0204] Example 2 by %FVC and PaCO 2 Effectiveness evaluation after half a year of administration

[0205] The so-called "%FVC" (percent-predicted forced vital capacity) is the forced vital capacity expressed in %, and is an index commonly used as an objective method of evaluating respiratory function of ALS patients (ALS Treatment Guidelines 2002). In addition, according to The BDNF Study Group (Phase III), Neurology, 52, 1427 (1999), the %FVC decrease rate of ALS patients was 13.8% (placebo group) in 6 months.

[0206] (30mg group)

[0207] To 4 ALS patients, 1 ampoule of the aforementioned "Radicut 30 mg injection" was intravenously administered once a day for 30 minutes each time for 14 consecutive days (the first period of administration). After the end of the first period, a 2-week observation (drug withdrawal) period was set, and then the same intravenous administration (administration in the second period) was performed for 10 days (no administration on Saturdays, Sun...

Embodiment 3

[0214] Example 3 Safety evaluation after administration for half a year

[0215] The clinical examination items in the patients of Example 2 were measured.

[0216] (test methods)

[0217] Using a large-scale multi-item automatic analyzer (Automatic Analizer 7600-020s manufactured by Hitachi), the following inspection items before and after administration were measured. From the values ​​(mean values) before and after administration shown below, it is clear that in the administration method of the medicament of the present invention, after the administration of edaravone, there is no abnormal increase in the clinical examination value, and there is no abnormality in safety. question.

[0218] Check item

Before administration

after administration

GOT(IU / I)

21.3

19.1

GPT(IU / I)

22.2

19.6

γ-GTP (IU / I)

31.6

25.3

BUN (mg / dl)

14.1

14.3

Creatinine (mg / dl)

0.6

0....

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PUM

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Abstract

A drug for the treatment of and / or inhibiting the progress of amyotrophic lateral sclerosis (ALS) or diseases attributable to ALS, characterized by a method of using a pyrazolone derivative represented by the following formula (wherein the symbols are the same as defined in the description) and by the dose of the derivative and the period of administration thereof.

Description

technical field [0001] The present invention relates to an agent for treating amyotrophic lateral sclerosis (hereinafter, sometimes also referred to as ALS) or symptoms caused by ALS and / or suppressing its development. Background technique [0002] ALS, one of the motor neuron diseases, is a difficult disease that begins with initial symptoms such as hand weakness, finger movement disorder, and upper limb fasciculation, and progresses through muscle atrophy, decreased muscle strength, bulbar paralysis, and muscle fasciculation, leading to respiratory failure. ALS can be divided into upper extremity type, spherical type, lower extremity type, and mixed type according to the location of the onset. No matter which type, it invades the musculature of the whole body with the development of its symptoms. [0003] The etiology of ALS is not very clear, the main etiology has the following five hypotheses: (1) autoimmune theory (the appearance of autoantibodies against Ca channels), ...

Claims

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Application Information

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IPC IPC(8): C07D231/22A61K31/4152A61P21/00
Inventor 吉野英米冈孝友
Owner MITSUBISHI TANABE PHARMA CORP
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