JP-2025514192-A5 -

Dates

Publication Date

20260507

Application Date

20230424

Description

All patents, patent applications, websites, other publications or documents, accession numbers, etc., cited herein are incorporated by reference in whole for all purposes, as if each individual item were specifically and individually indicated to be incorporated by reference in that manner. The present invention provides, for example, the following items: (Item 1) A method for treating a condition related to abnormal function of sodium ion channels in a subject requiring treatment, comprising administering compound 1 or a pharmaceutically acceptable salt thereof to the subject in a dose of about 1 mg to about 150 mg, wherein compound 1 is a compound with the following structural formula. (Item 2) The method according to item 1, wherein the condition related to the abnormal function of sodium ion channels is a neurological disorder. (Item 3) The method according to item 2, wherein the neurological disorder is a disorder related to excessive neuronal excitability. (Item 4) The method according to item 2 or 3, wherein the neurological disorder is associated with one or more de novo gain-of-function or loss-of-function mutations in a central nervous system sodium ion channel gene. (Item 5) The method according to any one of items 1 to 4, wherein the condition is epilepsy or epileptic syndrome. (Item 6) The method according to item 5, wherein the condition is hereditary epilepsy or hereditary epilepsy syndrome. (Item 7) The method according to item 5, wherein the condition is childhood epilepsy or childhood epileptic syndrome. (Item 8) The method according to any one of items 1 to 7, wherein the aforementioned condition is selected from the group consisting of malignant migratory infant focal seizures (MMFSI), infant epilepsy with migratory focal seizures (EIMFS), autosomal dominant nocturnal frontal lobe epilepsy (ADNFLE), West syndrome, infant spasm, epileptic encephalopathy, focal epilepsy, Ohtahara syndrome, developmental epileptic encephalopathy, Lennox-Gastaut syndrome, seizures, leukodystrophy, leukoencephalopathy, intellectual disability, multifocal epilepsy, drug-resistant epilepsy, temporal lobe epilepsy, and cerebellar ataxia. (Item 9) The method described in item 8, wherein the condition is epileptic encephalopathy. (Item 10) The method described in item 8, wherein the condition is focal epilepsy. (Item 11) The method according to item 8, wherein the seizure is a generalized tonic-clonic seizure or an asymmetric tonic seizure. (Item 12) The method according to any one of items 1 to 11, wherein the subject is a human. (Item 13) The method according to any one of items 1 to 12, wherein compound 1 is administered in a dose of approximately 5 mg to approximately 130 mg. (Item 14) The method according to item 13, wherein compound 1 is administered in doses of approximately 5 mg, approximately 10 mg, approximately 15 mg, approximately 20 mg, approximately 25 mg, approximately 30 mg, approximately 35 mg, approximately 40 mg, approximately 45 mg, approximately 50 mg, approximately 55 mg, approximately 60 mg, approximately 65 mg, approximately 70 mg, approximately 75 mg, approximately 80 mg, approximately 85 mg, approximately 90 mg, approximately 95 mg, approximately 100 mg, approximately 105 mg, approximately 110 mg, approximately 115 mg, approximately 120 mg, approximately 125 mg, or approximately 130 mg. (Item 15) The method according to any one of items 1 to 14, wherein administration of compound 1 results in a reduction in the severity, frequency, and/or frequency of seizures experienced by the subject, compared to the severity, frequency, and/or frequency of seizures experienced by the subject before administration of compound 1. (Item 16) The method according to any one of items 1 to 15, wherein administration of compound 1 does not cause ataxia, lethargy, and vomiting in the subject. (Item 17) A method for reducing the severity, frequency, and/or number of seizures in a subject requiring such reduction, wherein the method comprises an effective amount of compound 1 of the following structural formula: A method comprising administering a pharmaceutically acceptable salt thereof to the subject. (Item 18) The method according to item 17, wherein the subject has a condition related to abnormal function of sodium ion channels. (Item 19) The method according to item 18, wherein the condition related to the abnormal function of sodium ion channels is a neurological disorder. (Item 20) The method according to item 19, wherein the neurological disorder is a disorder related to excessive neuronal excitability. (Item 21) The method according to item 19 or 20, wherein the neurological disorder is associated with one or more de novo gain-of-function or loss-of-function mutations in a central nervous system sodium ion channel gene. (Item 22) The method according to any one of items 18 to 21, wherein the condition is epilepsy or epileptic syndrome. (Item 23) The method according to item 22, wherein the condition i