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Medicinal agent for treating amyotrophic lateral sclerosis or preventing progression of phase of amyotrophic lateral sclerosis

A technology for lateral sclerosis and muscular atrophy, applied to muscular system diseases, neuromuscular system diseases, medical preparations containing active ingredients, etc. Questions such as times

Inactive Publication Date: 2014-06-25
MITSUBISHI TANABE PHARMA CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In Patent Document 1, although it is suggested or taught that 3-methyl-1-phenyl-2-pyrazolin-5-one is useful for ALS treatment, it does not specifically disclose the administration method and administration amount to patients and the number of administrations, etc.

Method used

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  • Medicinal agent for treating amyotrophic lateral sclerosis or preventing progression of phase of amyotrophic lateral sclerosis
  • Medicinal agent for treating amyotrophic lateral sclerosis or preventing progression of phase of amyotrophic lateral sclerosis
  • Medicinal agent for treating amyotrophic lateral sclerosis or preventing progression of phase of amyotrophic lateral sclerosis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0142] (experiment method)

[0143] 199 ALS patients meeting the following selection criteria were divided into an actual drug administration group of 100 and a placebo administration group of 99.

[0144] 1) According to EL Escorial's revised Airlie House diagnostic criteria, it is suitable for any one of "ALS confirmed", "ALS probable", "ALS probable and positive" or "ALS probable"

[0145] 2) Can eat, excrete, and move without assistance in daily life

[0146] 3) Within 3 years after the onset of ALS symptoms

[0147] 4) Age is greater than or equal to 20 years old and less than or equal to 75 years old

[0148] 5) The amount of change in the ALSFRS-R score 12 weeks before the start of administration is -1 to -4 points

[0149] 6) No dyspnea caused by decreased respiratory function

[0150] 7) There are no complications such as Parkinson's disease, schizophrenia, dementia, etc. that may affect the evaluation of drug efficacy

[0151] In the actual drug administration g...

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Abstract

The purpose of the present invention is to provide a novel medicinal agent and a novel method both of which can be used for treating ALS (amyotrophic lateral sclerosis), preventing the progression of the phase of ALS, treating a symptom associated with ALS, or preventing the progression of the phase of the symptom, and both of which can be particularly applied to patients who can be treated by the medicinal agent or the method highly effectively among ALS patients who are needed to be treated. According to the present invention, a medicinal agent which can be used for treating amyotrophic lateral sclerosis, preventing the progression of the phase of amyotrophic lateral sclerosis, treating a symptom associated with amyotrophic lateral sclerosis, or preventing the progression of the phase of the symptom is provided. The medicinal agent comprises 3-methyl-1-phenyl-2-pyrazolin-5-one or a physiologically acceptable salt thereof as an active ingredient, is administered in such a manner that a 14-day dosing period and a 14-day washout period are repeated alternately or in such a manner that a 14-days initial dosing period and a subsequent 14-day initial washout period are set and subsequently a dosing period in which the dosing is carried out for any 10 days of 14 days and a 14-day washout period are repeated alternately, and is administered to a patient who meets specific criteria.

Description

technical field [0001] The present invention relates to an agent for treating or inhibiting the progression of amyotrophic lateral sclerosis (hereinafter, sometimes referred to as ALS), or for treating or inhibiting the progression of symptoms caused by ALS. Background technique [0002] ALS, one of the motor neuron diseases, progresses from initial symptoms such as hand weakness, movement disorder of the fingers, and contracture of fiber bundles of the upper limbs to respiratory failure through muscle atrophy, muscle weakness, bulbar palsy, and contracture of muscle fiber bundles. Refractory disease. ALS is divided into upper extremity type, bulbar type, lower extremity type, and mixed type according to the location of symptoms, and any type invades the muscles of the whole body as symptoms progress. The etiology of ALS has not yet been fully elucidated, but as the main etiology, (1) autoimmune theory (appearance of autoantibodies against Ca channels), (2) excitatory amino...

Claims

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Application Information

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IPC IPC(8): A61K31/4152A61P11/16A61P21/02A61P21/04A61P25/00C07D231/26
CPCA61K31/4015C07D231/26A61K31/4152A61P11/16A61P21/00A61P21/02A61P21/04A61P25/00A61P25/28
Inventor 米冈孝友
Owner MITSUBISHI TANABE PHARMA CORP
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