JP2019059773A - 抗コネクシン剤としてのフレカイニドの使用、及び向精神薬の効果を増強する方法 - Google Patents
抗コネクシン剤としてのフレカイニドの使用、及び向精神薬の効果を増強する方法 Download PDFInfo
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- JP2019059773A JP2019059773A JP2018233114A JP2018233114A JP2019059773A JP 2019059773 A JP2019059773 A JP 2019059773A JP 2018233114 A JP2018233114 A JP 2018233114A JP 2018233114 A JP2018233114 A JP 2018233114A JP 2019059773 A JP2019059773 A JP 2019059773A
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- flecainide
- disorder
- connexin
- modafinil
- sleep
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Abstract
Description
本発明は、抗コネクシン剤としてのフレカイニドの使用に関する。この抗コネクシン剤は、様々な向精神薬の治療効果を増強するために有利には使用される。より具体的には、本発明は、フレカイニドとモダフィニルとを有するコンビネーションプロダクトを提供する。
細胞接触が確立されると、細胞のコネクソンは、隣接細胞のコネクソン(those)と共に、端と端とを縦につないで(end-to-end)整列する。この結合チャネルは、細胞間の空間上で接触している2つの細胞の細胞質間において直接的な接触を確立する。
−癌(WO2006/134494及びWO2006/049157)、
−いくつかの心血管疾患(WO2006/134494)、
−傷(WO2006/134494及びWO2009/097077)、
−痛み(WO2009/148613)、
−偏頭痛(DurhamとGarrett, 2009),
−てんかん(JuszczakとSwiergiel、2009)、
−神経学的状態(WO2006/134494)及び神経変性疾患(Takeuchi et al. 2011)、
−虚血(Davidson et al, 2013)、
−薬剤誘発性肝障害(Patel et al, 2012)
−感染症(WO2011/067607)、
−化学療法剤によって誘導される細胞毒性(Tong X. et al,
2013)及び
−炎症性障害(WO2006/134494)。
本発明の文脈において、「フレカイニド」は、式N−(ピペリジン−2−イルメチル)−2,5−ビス(2,2,2−トリフルオロエトキシ)ベンズアミドの化合物を指す。本明細書で使用されるこの用語は、この化合物のいずれの形態、例えばその塩を指す。好ましくは、前記塩は、酢酸フレカイニドである。この用語はまた、人体内で代謝され得るフレカイニド前駆体及び/又はその誘導体(例えば、一つもしくは複数のハロゲン置換から、及び/又は保護基の付加から生じる化学的誘導体)を包含することができる。
i)蒸留ジエチルエーテルで、アルカリ化サンプルの単一ステップ抽出を行った後、
ii)の有機層を蒸発させ、且つ薬剤を80℃で2時間、1−[(4−ニトロフェニル)スルホニル]−L−プロピルクロリドで誘導体化し、
iii)アセトニトリル:水:トリエチルアミン(45:55:0.2)からなる移動相を有するC18逆相カラム上で、1mL/分の流量で高速液体クロマトグラフィー(HPLC)により、
分離された[Alessi−Severini et al.,1990]。
1.全身(general)麻酔薬;2.エーテル;3.ジエチルエーテル、ビニルエーテル;4.ハロゲン化炭化水素;5.ハロタン、クロロホルム、エンフルラン、トリクロロエチレン、イソフルラン、デスフルラン、セボフルラン;6.バルビツール酸塩(barbiturates)、プレーン;7.メトヘキシタール、ヘキソバルビタール;8.他の薬剤と組み合わせたバルビツール酸塩;9.ナルコバルビタール;10.オピオイド麻酔薬;11.フェンタニル、アルフェンタニル、スフェンタニル、フェノペリジン、アニレリジン、レミフェンタニル;12.その他の全身麻酔薬;13.ドロペリドール、ケタミン、プロパニジド、アルファキサロン、エトミデート、プロポフォール、ナトリウムオキシベート、亜酸化窒素、エスケタミン、キセノン;
14.局所麻酔薬;アミノ安息香酸のエステル;16.メタブテタミン、プロカイン、テトラカイン、クロロカイン、ベンゾカイン;17.アミド;18.ブピバカイン、リドカイン、メピバカイン、プリロカイン、ブタニリカイン、シンコカイン、エチドカイン、アルチカイン、ロピバカイン、レボブピバカイン、ブピバカイン;19.安息香酸のエステル;20.コカイン;21.その他の局所麻酔薬;22.塩化エチル、ジクロニン、フェノール;カプサイシン;
23.オピオイド;24.天然アヘンアルカロイド;25.アヘン、ヒドロモルフォン、ニコモルヒネ、オキシコドン、ジヒドロコデイン、ジアモルフィン、パパベレタム、モルヒネ、コデイン;26.フェニルピペリジン誘導体;27.ケトベミドン、ペチジン;28.ジフェニルプロピルアミン誘導体;29.デキストロモラミド、ピリトラミド、デキストロプロポキシフェン、ベジトラミド、メタドン;30.ベンゾモルファン誘導体;31.ペンタゾシン、フェナゾシン;32.モルフィナン誘導体;33.ブトルファノール、ナルブフィン;34.その他のオピオイド;35.チリジン、トラマドール、デゾシン、メプタジノール、タペンタドール;
36.その他の鎮痛薬と解熱薬;37.サリチル酸及び誘導体;38.アセチルサリチル酸、アロキシピリン、サリチル酸コリン、サリチル酸ナトリウム、サリチルアミド、サルサレート、エテンザミド、サリチル酸モルホリン、ジピロセチル、ベノリラート、ジフルニサル、サリチル酸カリウム、グアセチサル、カルバサラートカルシウム;サリチル酸イミダゾール;39.ピラゾロン;40.フェナゾン、メタミゾールナトリウム、アミノフェナゾン、プロピフェナゾン、ニフェナゾン;41.アニリド;42.パラセタモール、フェナセチン、ブセチン、プロパセタモール;43.その他の鎮痛薬と解熱薬;44.リマゾリウム、グラフェニン、フロクタフェニン、ビミノール、ネフォパム、ジコノチド、メトキシフルラン、ナビキシモルス;
45.抗偏頭痛製剤(preparations);46.麦角アルカロイド;47.ジヒドロエルゴタミン、エルゴタミン、メチセルギド、リスリド;48.副腎皮質ホルモン誘導体;49.フルメドロキソン;50.選択的セロトニン(5HT1)アゴニスト;51.スマトリプタン、ナラトリプタン、ゾルミトリプタン、リザトリプタン、アルモトリプタン、エレトリプタン、フロバトリプタン;52.その他の抗偏頭痛製剤;53.ピゾチフェン、クロニジン、イプラゾクロム、ジメトチアジン、オキセトロン;
54.抗てんかん薬;55.バルビツール酸塩及び誘導体;56. メチルフェノバルビタール、フェノバルビタール、プリミドン、バルベキサクロン、メタルビタール;57.ヒダントイン誘導体;58.エトトイン、フェニトイン、アミノ(ジフェニルヒダントイン)吉草酸、メフェニトイン、ホスフェニトイン;59.オキサゾリジン誘導体;60.パラメタジオン、トリメタジオン、エタジオン;61.スクシンイミド誘導体;62.エトスクシミド、フェンスクシミド、メスクシミド;63.ベンゾジアゼピン誘導体;64.クロナゼパム;65.カルボキサミド誘導体;66.カルバマゼピン、オクスカルバゼピン、ルフィナマイド、エスリカルバゼピン;67.脂肪酸誘導体;68.バルプロ酸、バルプロミド、アミノ酪酸、ビガバトリン、プロガビド、チアガビン;69.その他の抗てんかん薬;70.スルチアム、フェナセミド、ラモトリギン、フェルバメート、トピラメート、ガバペンチン、フェネツリッド、レベチラセタム、ゾニサミド、プレガバリン、スチリペントール、ラコサミド、カリスバメート、レチガビン、ベクラミド;
71.抗コリン作動性剤;72.第3アミン;73.トリヘキシフェニジル、ビペリデン、メチキセン、プロシクリジン、プロフェナミン、デキセチミド、フェングルタルイミド、マザチコール、ボルナプリン、トロパテピン;74.抗ヒスタミン薬に化学的に近いエーテル;75.エタナウチン、オルフェナドリン;76.トロピンもしくはトロピン誘導体のエーテル;77.ベンズアトロピン、エチベンズアトロピン;
78.ドーパミン作動性剤;79.ドーパ及びドーパ誘導体;80.レボドパ、デカルボキシラーゼ阻害剤、COMT阻害剤、メレボドパ、エチレボドパ;81.アダマンタン誘導体;82.アマンタジン;83.ドーパミンアゴニスト;84.ブロモクリプチン、ペルゴリド、ジヒドロエルゴクリプチン、エシレート、ロピニロール、プラミペキソール、カベルゴリン、アポモルヒネ、ピリベジル、ロチゴチン;85.モノアミンオキシダーゼB阻害剤;86.セレギリン、ラサギリン;87.その他のドーパミン作動性剤;88.トルカポン(olcapone)、エンタカポン、ブジピン;
89.抗精神剤;90.脂肪酸側鎖を有するフェノチアジン;91.クロルプロマジン、レボメプロマジン、プロマジン、アセプロマジン、トリフルプロマジン、シアメマジン、クロルプロエタジン;92.ピペラジン構造を有するフェノチアジン;93.ジキシラジン、フルフェナジン、ペルフェナジン、プロクロルペラジン、チオプロパゼート、トリフルオペラジン、アセトフェナジン、チオプロペラジン、ブタペラジン、ペラジン;94.ピペリジン構造を有するフェノチアジン;95.ペリシアジン、チオリダジン、メソリダジン、ピポチアジン;96.ブチロフェノン誘導体;97.ハロペリドール、トリフルペリドール、メルペロン、モペロン、ピパンペロン、ブロムペリドール、ベンペリドール、ドロペリドール、フルアニソン;98.インドール誘導体;99.オキシペルチン、モリンドン、セルチンドール、ジプラシドン;100.チオキサンテン誘導体;101.フルペンチキソール、クロペンチキソール、クロルプロチキセン、チオチキセン、ズクロペンチキソール;102.ジフェニルブチルピペリジン誘導体;103.フルスピリレン、ピモジド、ペンフルリドール;104.ジアゼピン、オキサゼピン、チアゼピン及びオキセピン;105.ロキサピン、クロザピン、オランザピン、クエチアピン、アセナピン、クロチアピン;106.ベンズアミド;107.スルピリド、スルトプリド、チアプリド、レモキシプリド、アミスルプリド、ベラリプリド、;レボスルピリド;108.リチウム;109.リチウム;110.その他の抗精神病薬;111.プロチペンジル、リスペリドン、モサプラミン、ゾテピン、アリピプラゾール、パリペリドン;
112.抗不安薬;113.ベンゾジアゼピン誘導体;114.クロルジアゼポキシド、メダゼパム、オキサゼパム、クロラゼプ酸カリウム、ロラゼパム、アジナゾラム、ブロマゼパム、クロバザム、ケタゾラム、プラゼパム、アルプラゾラム、ハラゼパム、ピナゼパム、カマゼパム、ノルダゼパム、フルジアゼパム、ロフラゼプ酸エチル、エチゾラム、クロチアゼパム、クロキサゾラム、トフィソパム;115.ジフェニルメタン誘導体;116.ヒドロキシジン、カプトジアム;117.カルバメート;118.メプロバメート、エミルカメート、メブタメート;119.ジベンゾビシクロ−オクタジエン誘導体;120.ベンゾクタミン;121.アザスピロデカンジオン誘導体;122.ブスピロン;123.その他の抗不安薬;124.メフェノキサロン、ゲドカルニル、エチホキシン;
125.睡眠薬及び鎮静薬;126.バルビツール酸塩、プレーン;127.ペントバルビタール、アモバルビタール、ブトバルビタール、バルビタール、アプロバルビタール、セコバルビタール、タルブタール、ビニルビタール、ビンバルビタール、シクロバルビタール、ヘプタバルビタール、レポサール、メトヘキシタール、チオペンタール、エタロバルビタール、アロバルビタール、プロキシバルバール;128.アルデヒド及び誘導体;129.抱水クロラール、クロラロドール、アセチルグリシンアミド、ジクロラルフェナゾン、パラアルデヒド;130.ベンゾジアゼピン誘導体;131.フルラゼパム、ニトラゼパム、フルニトラゼパム、エスタゾラム、トリアゾラム、ロルメタゼパム、テマゼパム、ミダゾラム、ブロチゾラム、クアゼパム、ロプラゾラム、ドキセファゼパム、シノラゼパム;132.ピペリジンジオン誘導体;133.グルテチミド、メチプリロン、ピリチルジオン;134.ベンゾジアゼピン関連薬物;135.ゾピクロン、ゾルピデム、ザレプロン、エスゾピクロン;136.メラトニン受容体アゴニスト;137.メラトニン、ラメルテオン;138.その他の睡眠薬及び鎮静薬;139.メタカロン、クロメチアゾール、ブロムワレリル尿素(ブロミソバール,bromisoval)、カルブロマール、スコポラミン、プロピオマジン、トリクロホス、エトクロルビノール、セイヨウカノコソウ(valerian)、ヘキサプロピマート、臭化物、アプロナール、バルノクタマイド、メチルペンチノール、ニアプラジン、デクスメデトミジン;140.バルビツール酸塩を除く、組み合わせにおける睡眠薬及び鎮静薬;141.エメプロニウム、ジピペロニルアミノエタノール;
142.抗うつ薬;143.非選択的モノアミン再取り込み阻害剤;144.デシプラミン、イミプラミン酸化物、クロミプラミン、オピプラモール、トリミプラミン、ロフェプラミン、ジベンゼピン、アミトリプチリン、ノルトリプチリン、プロトリプチリン、ドキセピン、イプリンドール、メリトラセン、ブトリプチリン、ドスレピン、アモキサピン、ジメタクリン、アミネプチン、マプロチリン、キヌプラミン;145.選択的セロトニン再取り込み阻害剤;146.ジメルジン、フルオキセチン、シタロプラム、パロキセチン、セルトラリン、アラプロクラート、フルボキサミン、エトペリドン、エスシタロプラム;147.モノアミンオキシダーゼ阻害剤、非選択的;148.イソカルボキサジド、ニアラミド、フェネルジン、トラニルシプロミン、イプロニアジド、イプロクロジド;149.モノアミンオキシダーゼA阻害剤;150モクロベミド、トロキサトン;151その他の抗うつ薬;152.オキシトリプタン、トリプトファン、ミアンセリン、ノミフェンシン、トラゾドン、ネファゾドン、ミナプリン、ビフェメラン、ビロキサジン、オキサフロザン、ミルタザピン、ブプロピオン、メジホキサミン、チアネプチン、ピバガビン、ベンラファキシン、ミルナシプラン、レボキセチン、ゲピロン、デュロキセチン、アゴメラチン、デスベンラファキシン;
153.精神刺激薬であって、ADHD及び向知性薬に使用される剤;154.中枢作用交感神経興奮;155.アンフェタミン、デキサムフェタミン、メタムフェタミン、メチルフェニデート、ペモリン、フェンカムファミン、モダフィニル、アルモダフィニル、フェノゾロン、アトモキセチン、フェネチリン、デクスメチルフェニデート(exmethylphenidate)、リスデキサンフェタミン;156.キサンチン誘導体;157.カフェイン、プロペントフィリン;158.その他の精神刺激薬及び向知性薬;159.メクロフェノキサート、ピリチノール、ピラセタム、デアノール、フィペキシド、シチコリン、オキシラセタム、ピリスダノール、リノピルジン、ニゾフェノン、アニラセタム、アセチルカルニチン、イデベノン、プロリンタン、ピプラドロール、プラミラセタム、アドラフィニル、ビンポセチン、ピトリサント;
160.抗認知症薬;161.抗コリンエステラーゼ;162.タクリン、ドネペジル、リバスチグミン、ガランタミン;163その他の抗認知症薬;164.メマンチン、イチョウ(ginko biloba);
165.副交感神経薬;166.抗コリンエステラーゼ;167.ネオスチグミン、ピリドスチグミン、ジスチグミン、アンベノニウム;168.コリンエステル;169.カルバコール、ベタネコール;170.その他の副交感神経薬;171.ピロカルピン、コリンアルホスセラート、セビメリン;
172.嗜癖性障害において使用される薬物;173.ニコチン依存症において使用される薬物;174.ニコチン、バレニクリン;175.アルコール依存症において使用される薬物;176.ジスルフィラム、カルシウムカルビミド、アカンプロセート、ナルトレキソン、バクロフェン;177.オピオイド依存症において使用される薬物;178.ブプレノルフィン、レバセチルメタドール、ロフェキシジン;
179.抗眩暈製剤;180.抗眩暈製剤;181.ベタヒスチン、シンナリジン、フルナリジン、アセチルロイシン;
182.その他の神経系薬;183.その他の神経系薬;184.チリラザド、リルゾール、キサリプロデン、アミファンプリジン、テトラベナジン、ファンプリジン、マジンドール。
日中の過度の眠気(EDS)、睡眠障害、不十分な睡眠時間、中枢性睡眠時無呼吸、(脱力発作の有無にかかわらず)ナルコレプシー、閉塞性睡眠時無呼吸/低呼吸(SAHOS)、特発性過眠症、クライン・レビン症候群、概日リズム障害、交代勤務睡眠障害、時差ぼけ、睡眠制限もしくは睡眠不足後の障害(注意障害、覚醒障害、眠気)、下肢静止不能症候群(RLS)と周期性四肢運動障害(PLMD)、不眠、錯眠、注意欠陥多動性障害(ADHD)、心的外傷後ストレス障害(PTSD)、一般的に傾眠もしくは眠気を伴う疾患(例えば、パーキンソン病、多発性硬化症、脳卒中、神経筋障害もしくは構造的脳障害、呼吸器障害、慢性腎不全、肝不全、リウマチ性疾患)、(ベンゾジアゼピン、バルビツレート、睡眠薬、抗うつ薬、抗精神病薬、等に起因する)薬によって誘発される傾眠、気分障害、不安障害、統合失調症、耳鳴り、うつ、倦怠感、認知症、双極性障害、肥満、過食症、躁病エピソード、強迫性障害、老衰、(ゲーム、麻薬、アルコール、タバコ等への)依存症もしくは嗜癖、糞便もしくは尿失禁、早漏、呼吸困難、及び特に癌、神経変性疾患、更年期障害、外傷性脳損傷、ウイルス感染もしくは後脊髄炎、又は線維筋痛症に起因する、疲労、
からなる群に含まれる精神科、神経学的及び/又は神経変性疾患を有してよい。
・個人は眠りへの衝動と戦う必死の努力をするにもかかわらず、それらは多くの場合抑えられない(irresistible)。
・それらの長さは、環境要因によって変化し得るが(例えば、受動的な活動、例えばテレビを見ることにより、持続時間を増やすことができる)、それらは通常短い。
・それらは、頻繁に夢に関連している。
・それらは、典型的には、数時間までの通常の覚醒状態を復元する。
不十分な睡眠時間、中枢性睡眠時無呼吸、(脱力発作の有無にかかわらず)ナルコレプシー、閉塞性睡眠時無呼吸/低呼吸(SAHOS)、特発性過眠症、クライン・レビン症候群、概日リズム障害(時差ぼけ)、睡眠制限もしくは睡眠不足後の障害(注意障害、覚醒障害、眠気)、下肢静止不能症候群(RLS)と周期性四肢運動障害(PLMD)、一般的に眠気に関連した神経学的状態(例えば、パーキンソン病、多発性硬化症、脳卒中、神経筋障害もしくは構造的脳障害)、一般的に眠気に関連した医学的状態呼吸器障害、慢性腎不全、肝不全、リウマチ性疾患)、気分障害、不安障害、統合失調症、又は薬物療法誘発性傾眠(ベンゾジアゼピン、バルビツール酸塩、睡眠薬、抗うつ薬、抗精神病薬、等に起因する)。
日中の過度の眠気(EDS)、睡眠障害、不十分な睡眠時間、中枢性睡眠時無呼吸、(脱力発作の有無にかかわらず)ナルコレプシー、閉塞性睡眠時無呼吸/低呼吸(SAHOS)、特発性過眠症、クライン・レビン症候群、概日リズム障害、交代勤務睡眠障害、時差ぼけ、睡眠制限又は睡眠不足後の障害(注意障害、覚醒障害、眠気)、下肢静止不能症候群(RLS)及び周期性四肢運動障害(PLMD)、不眠、錯眠、注意欠陥多動性障害(ADHD)、心的外傷後ストレス障害(PTSD)、一般的傾眠又は眠気に関連する障害(例えば、パーキンソン病、多発性硬化症、脳卒中、神経筋障害又は構造的脳障害、呼吸器障害、慢性腎不全、肝臓障害、リウマチ性疾患)、薬によって誘発される傾眠(ベンゾジアゼピン、バルビツレート、睡眠薬、抗うつ薬、抗精神病薬、等に起因する)、気分障害、不安障害、統合失調症、耳鳴り、うつ、倦怠感、認知症、双極性障害、肥満、過食症、躁病エピソード、強迫性障害、老衰、(ゲーム、麻薬、アルコール、タバコなどに対する)依存性や中毒、糞便や尿失禁、早漏、呼吸困難、及び特に癌、神経変性疾患、更年期障害、外傷性脳損傷、ウイルス感染もしくは後脊髄炎、又は線維筋痛症に起因する、疲労、に罹患した患者において、
モダフィニルの好記憶性効果及び/もしくは覚醒効果を増強するため、及び/又はその安全性を改善するため、及び/又はモダフィニルの作用の持続時間を増加させるため、使用するためのフレカイニドに関する。
日中の過度の眠気(EDS)、睡眠障害、不十分な睡眠時間、中枢性睡眠時無呼吸、(脱力発作の有無にかかわらず)ナルコレプシー、閉塞性睡眠時無呼吸/低呼吸(SAHOS)、特発性過眠症、クライン・レビン症候群、概日リズム障害、交代勤務睡眠障害、時差ぼけ、睡眠制限又は睡眠不足後の障害(注意障害、覚醒障害、眠気)、下肢静止不能症候群(RLS)及び周期性四肢運動障害(PLMD)、不眠、錯眠、注意欠陥多動性障害(ADHD)、心的外傷後ストレス障害(PTSD)、一般的傾眠又は眠気に関連する障害(例えば、パーキンソン病、多発性硬化症、脳卒中、神経筋障害又は構造的脳障害、呼吸器障害、慢性腎不全、肝臓障害、リウマチ性疾患)、薬によって誘発される傾眠(ベンゾジアゼピン、バルビツレート、睡眠薬、抗うつ薬、抗精神病薬、等に起因する)、気分障害、不安障害、統合失調症、耳鳴り、うつ、倦怠感、認知症、双極性障害、肥満、過食症、躁病エピソード、強迫性障害、老衰、(ゲーム、麻薬、アルコール、タバコなどに対する)依存性や中毒、糞便や尿失禁、早漏、呼吸困難、及び特に癌、神経変性疾患、更年期障害、外傷性脳損傷、ウイルス感染もしくは後脊髄炎、又は線維筋痛症に起因する、疲労、
に罹患した患者において、モダフィニルの覚醒効果を増強するため、及び/又はその安全性を改善するため、及び/又はモダフィニルの作用の持続時間を増加させるため、使用するための、フレカイニドに関する。
不十分な睡眠時間、中枢性睡眠時無呼吸、(脱力発作の有無にかかわらず)ナルコレプシー、閉塞性睡眠時無呼吸/低呼吸(SAHOS)、特発性過眠症、反復性過眠症(クライン・レビン症候群)、概日リズム障害(時差ぼけ)、睡眠制限又は睡眠不足後の障害(注意障害、覚醒障害及び眠気)、下肢静止不能症候群(RLS)と周期性四肢運動障害(PLMD)、一般に眠気と関連する神経学的状態(例えばパーキンソン病、多発性硬化症、脳卒中、神経筋障害又は構造的脳障害)、一般的に眠気に関連する医学的状態(呼吸器障害、慢性腎不全、肝不全、リウマチ性疾患)、気分障害、不安障害、統合失調症、又は薬物療法に誘導された眠気(ベンゾジアゼピンに、バルビツール酸塩、睡眠薬、抗うつ薬、抗精神病薬、等)である。
1.1.材料及び方法
細胞培養:
GJIC欠損、ラットインスリノーマRIN細胞株(del Corsso et al, 2006)を、10%ウシ胎児血清を補充したOptiMem培地中で増殖させた。GJB6(Cx30)、GJB1(CX32)、GJB2(Cx26)、GJA5(CX40)及びGJA1(Cx43)オープンリーディングフレームを、ヒトcDNAから増幅した。オープンリーディングフレームは、pcDNA3.1/V5−His−TOPO(Invitrogen)においてクローニングした。細胞を、リポフェクタミンを用いてトランスフェクションし、さらにジェネティシンを用いて選択した。
細胞を播種し、2種の蛍光色素、カルセインアセトキシメチルエステル、ギャップ結合浸透性色素、及びVybrant Dil、メンブレン親油性色素を負荷した。翌日、細胞を分離し、先に播種した非負荷細胞の存在下、及びフレカイニドラセミ体70、140又は280μΜ、メフロキン10μΜ又はメクロフェナム酸(MFA)100μΜの存在下で、4時間インキュベートした。フローサイトメトリーは、FACScanで行った。
RIN20,000個を、96ウェルプレート中の100μLの培地に播種した。48時間培養後、細胞をいくつかの濃度で以前に同定された化学化合物で4時間処理した。細胞をPBS中でリンスし、新鮮な培地で24時間増殖させた。細胞生存率をWST−1(Roche)を用いて測定した。
細胞モデルは、文献に記載された2つの古典的な阻害剤、メクロフェナム酸(MFA)(Dhein,2004)(100μΜ)及びメフロキン(Cruikshank et al, 2004)(10μΜ)を使用することによって検証された。結果は、図1Aに示される。フレカイニドは、他の抗コネクシン剤としてコネクシンをブロックするのに効率的である。
前臨床及び臨床データは、モダフィニルは、睡眠サイクルのリズムを変更し、覚醒相を促進することを示す(Lin et al, 2008)。ここでは、我々は、モダフィニルの経口負荷試験(oral challenge)後、フレカイニドこのような活動がフレカイニドによって増強されたかどうか、移植したマウスに睡眠ポリグラフ分析を用いて、げっ歯類でテストした。モダフィニルのサブ効率的な(sub-efficient)投与量を使用すると(32mg/kg)、本発明者らは、モダフィニル及びフレカイニドの組み合わせの新機能を実証した。当該組み合わせは、大幅に覚醒エピソードの全持続時間を増加させるためである。
野生型C57bl/6雄マウス(n=9/グループ)に、睡眠ポリグラフ分析のためのEEG/EMG/EOG電極を移植した。2週間の回復期間の後、マウスをビヒクル、モダフィニル32mg/kg及びモダフィニル32mg/kg+フレカイニドラセミ体1mg/kgで経口処理した。覚醒期間は、Spike2スクリプトを使用して定量化した。ここで、本発明者らは、(1−時間後に投与した後の)最初の3時間の間、覚醒の持続時間を表した。**:一元配置分散分析(One-Way ANOVA analysis)におけるp<0.01。
モダフィニルは、ヒト及びマウスにおいて覚醒を促進する分子であって、マウスにおいて、マウスらの(their)活動を用量依存的に増大させる(Simon et al, 1994)。モダフィニル32mg/kgで処置したマウスの活動を、モダフィニル32mg/kg+フレカイニド1mg/kgの併用又はビヒクルで処置したマウスの活動と比較した。
モダフィニルは、認知増強効果を誘発する(Beracochea et al, 2003)。このような特性は、交互シーケンシャルテスト、マウスにおける空間作業記憶を評価するのに広く使用されている装置を使用して、評価可能である(Beracochea&Jaffard,1987)。連続試行にわたって、T迷路デバイスの到着のコンパートメントに進入するため、彼らの選択を交互にするため、自発的交替行動(spontaneous alternation)は、げっ歯類の生得的な傾向である。所与の試行Nの間交替するため(alternate)、動物は、試験N−1で選択的に行った選択を覚えておく必要があり、且つ交替(alternating)における応答は、パフォーマンスの尺度である。迷路に入る前のモダフィニルの急性投与は、この試験におけるマウスのパフォーマンスを向上させることができる(Beracochea et al, 2001)。本発明者らの結果は、フレカイニドが著しく、モダフィニルの十分な用量の好記憶性効果を増強するのに対し、フレカイニド単独は、自らの好記憶性効果を欠いていることを示した。
交互シーケンシャルテストは、マウスにおける空間作業記憶を評価するのに広く使用されている(Beracochea&Jaffard,1987)。連続試行にわたって、T迷路デバイスの到着のコンパートメントに進入するため、彼らの選択を交互にするため、自発的交替行動(spontaneous alternation)は、げっ歯類の生得的な傾向である。所与の試行Nの間交替するため(alternate)、動物は、試験N−1で選択的に行った選択を覚えておく必要があり、それにより交替の低下は、忘却の現象を反映することになる。交替(alternating)における応答は、パフォーマンスの尺度である。シーケンシャルな交替は、より具体的には、干渉に対する感度、忘却の主要な要因を評価する。
*p<0.05、一元配置分散分析(One-Way ANOVA analysis)の後、モダフィニル群に対する(vs)テューキーの多重比較が続いた。
T迷路は、マウスにおける作業記憶を評価するための装置である。迷路に入る前のモダフィニルの急性投与は、この試験におけるマウスのパフォーマンスを向上させることができる(Beracochea et al,2001)。
モダフィニルは、ヒト及びマウスにおいて覚醒を促進する分子であって、マウスにおいて、マウスらの(their)活動を用量依存的に増大させる(Simon et al, 1994)。本発明者らの結果は、フレカイニドは、モダフィニルのサブ効率的な投与量の運動(locomotor)効果を著しく増強するのに対し、フレカイニド単独は、げっ歯類においていずれの自らの運動効果を欠いていることを示した。
モダフィニル(64mg/kg)又はモダフィニル(64mg/kg)及びフレカイニドのラセミ体(1mg/キログラム)又はフレカイニドラセミ体単独(1mg/キログラム)又はビヒクルのいずれかで、マウス(バッチ当たりn=8)を経口処理し、そしてそれらのホームケージ内に戻した(replaced)。自発運動活性は、ビデオ追跡により評価される。ビデオは、Ethovision XTソフトウェア(Noldus(登録商標))を用いて分析された。 *:二元配置分散分析(Two-Way ANOVA)においてp<0.01。
モダフィニル64mg/kgで処理したマウスの活動を、モダフィニル64mg/kg+フレカイニド1mg/kgの組み合わせで処理したマウスの活動と比較した。図4は、フレカイニドが、マウスの活動に対するモダフィニルの効果の持続を大幅に増加させることを示す。
5.1.材料と方法
動物
プレプロオレキシンノックアウト(KO)マウスはChemelli et al. [1999]によって生成されたマウス系統の子孫であった。且つC57BL/6Jゲノムバックグラウンドを維持した。9世代にわたる雄オレキシン−/−マウス及び雌野生型(WT)マウスの戻し交配後、取得したオレキシン+/−マウスは、ヘテロ接合体とホモ接合体、WTとKOとの同腹子を生産するために交配させた。オレキシン遺伝子に関するそれらの遺伝子型を決定するために、尾の生検を、PCRを使用するDNAの検出のために4週齢で行った。
手術
手術後、動物は、個別に収容され、23±1℃の周囲温度で、12時間の明/暗サイクルで維持された絶縁防音録音室(午前7時に点灯(lights-on))に配置された。7日間の回復期間後、ポリグラフの記録が開始される前の7日間、マウスを記録ケーブルに慣れさせた。何人かの著者[Chemelli et al, 1999; Mignot et al, 2005; Fujiki et al, 2006]により、ナルコレプシーエピソードもしくは睡眠開始REM期間とも呼ばれる、直接REM睡眠開始(DREMs)エピソードは、覚醒からの直接REM睡眠の発生として、即ち60秒の間5秒以上のいずれかの皮質の遅い活動によって先行されず、60秒以上続く覚醒エピソードに直接続くREMエピソードとして定義された。
外科手術からの回復及び記録ケーブルへの慣らしの後、各マウスに、午前7時に開始する、連続2日間のレコーディング・セッションを行った。投与を、ちょうど消灯(午後7時)前の午後6時45分に行った。なぜならばオレキシン−/−マウスは、もっぱら消灯相中にナルコレプシー発作を示すためである[Chemelli et al,1999]。投与の順序をランダム化した。ポリグラフ記録は、投与直後に行われ、且つ全消灯期間(12時間)の間維持された。2回の投与は、7日の期間によって分離した(休薬(washout))。マウス(バッチあたりn=8)を、モダフィニル(64mg/kg)又はモダフィニル(64mg/kg)及びフレカイニドのラセミ体(1mg/キログラム)又はフレカイニドラセミ体単独(1mg/キログラム)又はビヒクルのいずれかで経口処理した。
オレキシン(ヒポクレチンとしても知られている)は、1998年に同定された2つの視床下部の神経ペプチドである[Sakurai et al, 1998; De Lecea L. et al, 1998]。オレキシンを含むニューロンは、視床下部背外側及び脳弓周囲のエリアで確認されている。これらのニューロンは、行動覚醒に重要な役割を果たしている。エビデンスの大きなボディは、オレキシン欠損は、ヒト及び動物のナルコレプシー発病の原因であることを示している[Lin et al, 1999; Chemelli et al, 1999]。最近、オレキシンKOマウスのほとんどの主要な表現型は、
覚醒時の行動/運動障害、及び
覚醒状態から直接の奇異な(paradoxical)睡眠の突然の開始としてEEG、EMG及びビデオ録画において定義される、暗い相の間の睡眠開始REMのエピソードの発生(SOREMとして知られているDREM)であることが示されたは、[Anaclet et al,2009]。従ってSOREM/DREMは、ナルコレプシーの患者に頻繁に見られるネズミナルコレプシーの主な表現型を構成している[Lin et al, 2011]。このモデルを使用すると、モダフィニルはDREMのエピソードを持続する(persist)こと[Linら、2008]、モダフィニルは、日中の過度の眠気を改善するが、脱力発作において明らかな効果を有しないという診療所におけるのと同様の状況が示された。
フレカイニドのラセミ体を、R−フレカイニドエナンチオマーで置き換えたことを除き、実施例5と同じ材料及び方法を使用した。
1.全身(general)麻酔薬;2.エーテル;3.ジエチルエーテル、ビニルエーテル;4.ハロゲン化炭化水素;5.ハロタン、クロロホルム、エンフルラン、トリクロロエチレン、イソフルラン、デスフルラン、セボフルラン;6.バルビツール酸塩(barbiturates)、プレーン;7.メトヘキシタール、ヘキソバルビタール;8.他の薬剤と組み合わせたバルビツール酸塩;9.ナルコバルビタール;10.オピオイド麻酔薬;11.フェンタニル、アルフェンタニル、スフェンタニル、フェノペリジン、アニレリジン、レミフェンタニル;12.その他の全身麻酔薬;13.ドロペリドール、ケタミン、プロパニジド、アルファキサロン、エトミデート、プロポフォール、ナトリウムオキシベート、亜酸化窒素、エスケタミン、キセノン;
14.局所麻酔薬;アミノ安息香酸のエステル;16.メタブテタミン、プロカイン、テトラカイン、クロロプロカイン、ベンゾカイン;17.アミド;18.ブピバカイン、リドカイン、メピバカイン、プリロカイン、ブタニリカイン、シンコカイン、エチドカイン、アルチカイン、ロピバカイン、レボブピバカイン、ブピバカイン;19.安息香酸のエステル;20.コカイン;21.その他の局所麻酔薬;22.塩化エチル、ジクロニン、フェノール;カプサイシン;
23.オピオイド;24.天然アヘンアルカロイド;25.アヘン、ヒドロモルフォン、ニコモルヒネ、オキシコドン、ジヒドロコデイン、ジアモルフィン、パパベレタム、モルヒネ、コデイン;26.フェニルピペリジン誘導体;27.ケトベミドン、ペチジン;28.ジフェニルプロピルアミン誘導体;29.デキストロモラミド、ピリトラミド、デキストロプロポキシフェン、ベジトラミド、メタドン;30.ベンゾモルファン誘導体;31.ペンタゾシン、フェナゾシン;32.モルフィナン誘導体;33.ブトルファノール、ナルブフィン;34.その他のオピオイド;35.チリジン、トラマドール、デゾシン、メプタジノール、タペンタドール;
36.その他の鎮痛薬と解熱薬;37.サリチル酸及び誘導体;38.アセチルサリチル酸、アロキシピリン、サリチル酸コリン、サリチル酸ナトリウム、サリチルアミド、サルサレート、エテンザミド、サリチル酸モルホリン、ジピロセチル、ベノリラート、ジフルニサル、サリチル酸カリウム、グアセチサル、カルバサラートカルシウム;サリチル酸イミダゾール;39.ピラゾロン;40.フェナゾン、メタミゾールナトリウム、アミノフェナゾン、プロピフェナゾン、ニフェナゾン;41.アニリド;42.パラセタモール、フェナセチン、ブセチン、プロパセタモール;43.その他の鎮痛薬と解熱薬;44.リマゾリウム、グラフェニン、フロクタフェニン、ビミノール、ネフォパム、ジコノチド、メトキシフルラン、ナビキシモルス;
45.抗偏頭痛製剤(preparations);46.麦角アルカロイド;47.ジヒドロエルゴタミン、エルゴタミン、メチセルギド、リスリド;48.副腎皮質ホルモン誘導体;49.フルメドロキソン;50.選択的セロトニン(5HT1)アゴニスト;51.スマトリプタン、ナラトリプタン、ゾルミトリプタン、リザトリプタン、アルモトリプタン、エレトリプタン、フロバトリプタン;52.その他の抗偏頭痛製剤;53.ピゾチフェン、クロニジン、イプラゾクロム、ジメトチアジン、オキセトロン;
54.抗てんかん薬;55.バルビツール酸塩及び誘導体;56. メチルフェノバルビタール、フェノバルビタール、プリミドン、バルベキサクロン、メタルビタール;57.ヒダントイン誘導体;58.エトトイン、フェニトイン、アミノ(ジフェニルヒダントイン)吉草酸、メフェニトイン、ホスフェニトイン;59.オキサゾリジン誘導体;60.パラメタジオン、トリメタジオン、エタジオン;61.スクシンイミド誘導体;62.エトスクシミド、フェンスクシミド、メスクシミド;63.ベンゾジアゼピン誘導体;64.クロナゼパム;65.カルボキサミド誘導体;66.カルバマゼピン、オクスカルバゼピン、ルフィナマイド、エスリカルバゼピン;67.脂肪酸誘導体;68.バルプロ酸、バルプロミド、アミノ酪酸、ビガバトリン、プロガビド、チアガビン;69.その他の抗てんかん薬;70.スルチアム、フェナセミド、ラモトリギン、フェルバメート、トピラメート、ガバペンチン、フェネツリッド、レベチラセタム、ゾニサミド、プレガバリン、スチリペントール、ラコサミド、カリスバメート、レチガビン、ベクラミド;
71.抗コリン作動性剤;72.第3アミン;73.トリヘキシフェニジル、ビペリデン、メチキセン、プロシクリジン、プロフェナミン、デキセチミド、フェングルタルイミド、マザチコール、ボルナプリン、トロパテピン;74.抗ヒスタミン薬に化学的に近いエーテル;75.エタナウチン、オルフェナドリン;76.トロピンもしくはトロピン誘導体のエーテル;77.ベンズアトロピン、エチベンズアトロピン;
78.ドーパミン作動性剤;79.ドーパ及びドーパ誘導体;80.レボドパ、デカルボキシラーゼ阻害剤、COMT阻害剤、メレボドパ、エチレボドパ;81.アダマンタン誘導体;82.アマンタジン;83.ドーパミンアゴニスト;84.ブロモクリプチン、ペルゴリド、ジヒドロエルゴクリプチン、エシレート、ロピニロール、プラミペキソール、カベルゴリン、アポモルヒネ、ピリベジル、ロチゴチン;85.モノアミンオキシダーゼB阻害剤;86.セレギリン、ラサギリン;87.その他のドーパミン作動性剤;88.トルカポン(olcapone)、エンタカポン、ブジピン;
89.抗精神剤;90.脂肪酸側鎖を有するフェノチアジン;91.クロルプロマジン、レボメプロマジン、プロマジン、アセプロマジン、トリフルプロマジン、シアメマジン、クロルプロエタジン;92.ピペラジン構造を有するフェノチアジン;93.ジキシラジン、フルフェナジン、ペルフェナジン、プロクロルペラジン、チオプロパゼート、トリフルオペラジン、アセトフェナジン、チオプロペラジン、ブタペラジン、ペラジン;94.ピペリジン構造を有するフェノチアジン;95.ペリシアジン、チオリダジン、メソリダジン、ピポチアジン;96.ブチロフェノン誘導体;97.ハロペリドール、トリフルペリドール、メルペロン、モペロン、ピパンペロン、ブロムペリドール、ベンペリドール、ドロペリドール、フルアニソン;98.インドール誘導体;99.オキシペルチン、モリンドン、セルチンドール、ジプラシドン;100.チオキサンテン誘導体;101.フルペンチキソール、クロペンチキソール、クロルプロチキセン、チオチキセン、ズクロペンチキソール;102.ジフェニルブチルピペリジン誘導体;103.フルスピリレン、ピモジド、ペンフルリドール;104.ジアゼピン、オキサゼピン、チアゼピン及びオキセピン;105.ロキサピン、クロザピン、オランザピン、クエチアピン、アセナピン、クロチアピン;106.ベンズアミド;107.スルピリド、スルトプリド、チアプリド、レモキシプリド、アミスルプリド、ベラリプリド、;レボスルピリド;108.リチウム;109.リチウム;110.その他の抗精神病薬;111.プロチペンジル、リスペリドン、モサプラミン、ゾテピン、アリピプラゾール、パリペリドン;
112.抗不安薬;113.ベンゾジアゼピン誘導体;114.クロルジアゼポキシド、メダゼパム、オキサゼパム、クロラゼプ酸カリウム、ロラゼパム、アジナゾラム、ブロマゼパム、クロバザム、ケタゾラム、プラゼパム、アルプラゾラム、ハラゼパム、ピナゼパム、カマゼパム、ノルダゼパム、フルジアゼパム、ロフラゼプ酸エチル、エチゾラム、クロチアゼパム、クロキサゾラム、トフィソパム;115.ジフェニルメタン誘導体;116.ヒドロキシジン、カプトジアム;117.カルバメート;118.メプロバメート、エミルカメート、メブタメート;119.ジベンゾビシクロ−オクタジエン誘導体;120.ベンゾクタミン;121.アザスピロデカンジオン誘導体;122.ブスピロン;123.その他の抗不安薬;124.メフェノキサロン、ゲドカルニル、エチホキシン;
125.睡眠薬及び鎮静薬;126.バルビツール酸塩、プレーン;127.ペントバルビタール、アモバルビタール、ブトバルビタール、バルビタール、アプロバルビタール、セコバルビタール、タルブタール、ビニルビタール、ビンバルビタール、シクロバルビタール、ヘプタバルビタール、レポサール、メトヘキシタール、チオペンタール、エタロバルビタール、アロバルビタール、プロキシバルバール;128.アルデヒド及び誘導体;129.抱水クロラール、クロラロドール、アセチルグリシンアミド、ジクロラルフェナゾン、パラアルデヒド;130.ベンゾジアゼピン誘導体;131.フルラゼパム、ニトラゼパム、フルニトラゼパム、エスタゾラム、トリアゾラム、ロルメタゼパム、テマゼパム、ミダゾラム、ブロチゾラム、クアゼパム、ロプラゾラム、ドキセファゼパム、シノラゼパム;132.ピペリジンジオン誘導体;133.グルテチミド、メチプリロン、ピリチルジオン;134.ベンゾジアゼピン関連薬物;135.ゾピクロン、ゾルピデム、ザレプロン、エスゾピクロン;136.メラトニン受容体アゴニスト;137.メラトニン、ラメルテオン;138.その他の睡眠薬及び鎮静薬;139.メタカロン、クロメチアゾール、ブロムワレリル尿素(ブロミソバール,bromisoval)、カルブロマール、スコポラミン、プロピオマジン、トリクロホス、エトクロルビノール、セイヨウカノコソウ(valerian)、ヘキサプロピマート、臭化物、アプロナール、バルノクタマイド、メチルペンチノール、ニアプラジン、デクスメデトミジン;140.バルビツール酸塩を除く、組み合わせにおける睡眠薬及び鎮静薬;141.エメプロニウム、ジピペロニルアミノエタノール;
142.抗うつ薬;143.非選択的モノアミン再取り込み阻害剤;144.デシプラミン、イミプラミン、イミプラミン酸化物、クロミプラミン、オピプラモール、トリミプラミン、ロフェプラミン、ジベンゼピン、アミトリプチリン、ノルトリプチリン、プロトリプチリン、ドキセピン、イプリンドール、メリトラセン、ブトリプチリン、ドスレピン、アモキサピン、ジメタクリン、アミネプチン、マプロチリン、キヌプラミン;145.選択的セロトニン再取り込み阻害剤;146.ジメルジン、フルオキセチン、シタロプラム、パロキセチン、セルトラリン、アラプロクラート、フルボキサミン、エトペリドン、エスシタロプラム;147.モノアミンオキシダーゼ阻害剤、非選択的;148.イソカルボキサジド、ニアラミド、フェネルジン、トラニルシプロミン、イプロニアジド、イプロクロジド;149.モノアミンオキシダーゼA阻害剤;150モクロベミド、トロキサトン;151その他の抗うつ薬;152.オキシトリプタン、トリプトファン、ミアンセリン、ノミフェンシン、トラゾドン、ネファゾドン、ミナプリン、ビフェメラン、ビロキサジン、オキサフロザン、ミルタザピン、ブプロピオン、メジホキサミン、チアネプチン、ピバガビン、ベンラファキシン、ミルナシプラン、レボキセチン、ゲピロン、デュロキセチン、アゴメラチン、デスベンラファキシン;
153.精神刺激薬であって、ADHD及び向知性薬に使用される剤;154.中枢作用交感神経興奮;155.アンフェタミン、デキサムフェタミン、メタムフェタミン、メチルフェニデート、ペモリン、フェンカムファミン、モダフィニル、アルモダフィニル、フェノゾロン、アトモキセチン、フェネチリン、デクスメチルフェニデート(exmethylphenidate)、リスデキサンフェタミン;156.キサンチン誘導体;157.カフェイン、プロペントフィリン;158.その他の精神刺激薬及び向知性薬;159.メクロフェノキサート、ピリチノール、ピラセタム、デアノール、フィペキシド、シチコリン、オキシラセタム、ピリスダノール、リノピルジン、ニゾフェノン、アニラセタム、アセチルカルニチン、イデベノン、プロリンタン、ピプラドロール、プラミラセタム、アドラフィニル、ビンポセチン、ピトリサント;
160.抗認知症薬;161.抗コリンエステラーゼ;162.タクリン、ドネペジル、リバスチグミン、ガランタミン;163その他の抗認知症薬;164.メマンチン、イチョウ(ginko biloba);
165.副交感神経薬;166.抗コリンエステラーゼ;167.ネオスチグミン、ピリドスチグミン、ジスチグミン、アンベノニウム;168.コリンエステル;169.カルバコール、ベタネコール;170.その他の副交感神経薬;171.ピロカルピン、コリンアルホスセラート、セビメリン;
172.嗜癖性障害において使用される薬物;173.ニコチン依存症において使用される薬物;174.ニコチン、バレニクリン;175.アルコール依存症において使用される薬物;176.ジスルフィラム、カルシウムカルビミド、アカンプロセート、ナルトレキソン、バクロフェン;177.オピオイド依存症において使用される薬物;178.ブプレノルフィン、レバセチルメタドール、ロフェキシジン;
179.抗眩暈製剤;180.抗眩暈製剤;181.ベタヒスチン、シンナリジン、フルナリジン、アセチルロイシン;
182.その他の神経系薬;183.その他の神経系薬;184.チリラザド、リルゾール、キサリプロデン、アミファンプリジン、テトラベナジン、ファンプリジン、マジンドール。
Claims (27)
- フレカイニドと少なくとも1つの向精神薬とを有する治療用組成物であって、前記向精神薬はモダフィニルである、治療用組成物。
- 日中の過度の眠気(EDS)、睡眠障害、不十分な睡眠時間、中枢性睡眠時無呼吸、(脱力発作の有無にかかわらず)ナルコレプシー、閉塞性睡眠時無呼吸/低呼吸(SAHOS)、特発性過眠症、クライネ・レビン症候群、概日リズム障害、交代勤務睡眠障害、時差ぼけ、睡眠制限もしくは睡眠不足後の障害(注意障害、覚醒障害、眠気)、下肢静止不能症候群(RLS)と周期性四肢運動障害(PLMD)、不眠、錯眠、注意欠陥多動性障害(ADHD)、心的外傷後ストレス障害(PTSD)、一般的に傾眠もしくは眠気を伴う疾患(例えば、パーキンソン病、多発性硬化症、脳卒中、神経筋障害もしくは構造的脳障害、呼吸器障害、慢性腎不全、肝不全、リウマチ性疾患)、(ベンゾジアゼピン、バルビツレート、睡眠薬、抗うつ薬、抗精神病薬、等に起因する)薬によって誘発される傾眠、気分障害、不安障害、統合失調症、耳鳴り、うつ、倦怠感、認知症、双極性障害、肥満、過食症、躁病エピソード、強迫性障害、老衰、(ゲーム、麻薬、アルコール、タバコ等への)依存症もしくは嗜癖、糞便もしくは尿失禁、早漏、呼吸困難、及び特に癌、神経変性疾患、更年期障害、外傷性脳損傷、ウイルス感染もしくは脊髄炎、又は線維筋痛症に起因する、疲労、
を治療に使用するための、請求項1に記載の治療用組成物。 - 健常者の記憶を増強するのに及び/又は長期にわたる期間前記健常者の覚醒を維持するのに使用するための、請求項1又は2に記載の治療用組成物。
- ナルコレプシー患者において脱力発作を治療するのに使用するための、請求項1又は2に記載の治療用組成物。
- 日中の過度の眠気(EDS)、睡眠障害、不十分な睡眠時間、中枢性睡眠時無呼吸、(脱力発作の有無にかかわらず)ナルコレプシー、閉塞性睡眠時無呼吸/低呼吸(SAHOS)、特発性過眠症、クライネ・レビン症候群、概日リズム障害、交代勤務睡眠障害、時差ぼけ、睡眠制限もしくは睡眠不足後の障害(注意障害、覚醒障害、眠気)、下肢静止不能症候群(RLS)と周期性四肢運動障害(PLMD)、不眠、錯眠、注意欠陥多動性障害(ADHD)、心的外傷後ストレス障害(PTSD)、一般的に傾眠もしくは眠気を伴う疾患(例えば、パーキンソン病、多発性硬化症、脳卒中、神経筋障害もしくは構造的脳障害、呼吸器障害、慢性腎不全、肝不全、リウマチ性疾患)、(ベンゾジアゼピン、バルビツレート、睡眠薬、抗うつ薬、抗精神病薬、等に起因する)薬によって誘発される傾眠、気分障害、不安障害、統合失調症、耳鳴り、うつ、倦怠感、認知症、双極性障害、肥満、過食症、躁病エピソード、強迫性障害、老衰、(ゲーム、麻薬、アルコール、タバコ等への)依存症もしくは嗜癖、糞便もしくは尿失禁、早漏、呼吸困難、及び特に癌、神経変性疾患、更年期障害、外傷性脳損傷、ウイルス感染もしくは脊髄炎、又は線維筋痛症に起因する、疲労、
を予防及び/又は治療のため、同時、分離又はずらして使用するため、フレカイニドとモダフィニルとを有するコンビネーションプロダクト。 - 健常者の記憶を増強するのに及び/又は長期にわたる期間前記健常者の覚醒を維持するのに使用するための、請求項6に記載のコンビネーションプロダクト。
- ナルコレプシー患者において脱力発作を治療するのに使用するための、請求項6に記載のコンビネーションプロダクト。
- 抗コネクシン剤としてのフレカイニドのin vitro使用。
- コネクシン23,コネクシン25,コネクシン26,コネクシン30,コネクシン30.2,コネクシン30.3,コネクシン31,コネクシン31.1,コネクシン31.9,コネクシン32,コネクシン36,コネクシン37,コネクシン40,コネクシン40.1,コネクシン43,コネクシン45,コネクシン46,コネクシン47,コネクシン50,コネクシン59,及びコネクシン62からなる群から選択される1以上のコネクシン分子を遮断するための、請求項10又は11に記載のin vitro使用。
- コネクシン26,コネクシン30,コネクシン30.2,コネクシン32,コネクシン36,コネクシン37,コネクシン40,コネクシン43,コネクシン45,コネクシン46及びコネクシン47からなる群から選択される1以上のコネクシン分子を遮断するための、請求項10又は11に記載のin vitro使用。
- コネクシンCx40,コネクシンCx26,コネクシン30,コネクシン32,及びコネクシン43からなる群から選択される1以上のコネクシン分子を遮断するための、請求項10又は11に記載のin vitro使用。
- 向精神薬の効果を増強するため、好ましくは向精神薬の有効性及び/もしくは安全性及び/もしくは作用の持続時間を増加させるため、抗コネクシン剤として使用するためのフレカイニド。
- 前記向精神薬は、GABA作動性、ドーパミン作動性、ノルエピネフリン作動性、セロトニン作動性、ヒスタミン作動性、及びグルタミン酸作動性エフェクタ、及びヒポクレチン/オレキシン系に対する効果を有するもの、からなる群から選択される、請求項15に記載の使用のためのフレカイニド。
- 前記向精神薬は、カフェイン、マジンドール、ナトリウムオキシベート、ピトリサント、アンフェタミン、メチルフェニデート、(R)−(β−アミノベンゼンプロピル)カルバミン酸一塩酸塩、モダフィニル及びアルモダフィニルからなる群で選択される、請求項15又は16に記載の使用のためのフレカイニド。
- カフェイン、マジンドール、ナトリウムオキシベート、ピトリサント、アンフェタミン、メチルフェニデート、(R)−(β−アミノベンゼンプロピル)カルバミン酸一塩酸塩、モダフィニル及びアルモダフィニルからなる群で選択される向精神薬の効果を、好ましくはプロムネシアント効果及び/もしくは覚醒効果を増強するため、請求項15乃至17のいずれか一項に記載の使用のためのフレカイニド。
- カフェイン、マジンドール、ナトリウムオキシベート、ピトリサント、アンフェタミン、メチルフェニデート、(R)−(β−アミノベンゼンプロピル)カルバミン酸一塩酸塩、モダフィニル及びアルモダフィニルからなる群で選択される向精神薬の有効性及び/もしくは作用の持続時間を増加させるため、請求項15乃至18のいずれか一項に記載の使用のためのフレカイニド。
- 前記向精神薬はモダフィニルである、請求項15乃至19のいずれか一項に記載の使用のためのフレカイニド。
- フレカイニドと、少なくとも1の向精神薬とを有する治療用組成物であって、前記向精神薬はフルピルチンではない、治療用組成物。
- 前記向精神薬は、GABA作動性、ドーパミン作動性、ノルエピネフリン作動性、セロトニン作動性、ヒスタミン作動性、及びグルタミン酸作動性エフェクタ、及びヒポクレチン/オレキシン系に対する効果を有するもの、からなる群から選択される、請求項22に記載の治療用組成物。
- 前記向精神薬は、カフェイン、マジンドール、ナトリウムオキシベート、ピトリサント、アンフェタミン、メチルフェニデート、(R)−(β−アミノベンゼンプロピル)カルバミン酸一塩酸塩、モダフィニル及びアルモダフィニルからなる群で選択される向精神薬、好ましくはモダフィニルである、請求項22又は23に記載の治療用組成物。
- 傷、偏頭痛、感染症、薬剤誘発性肝障害、化学療法剤によって誘導される細胞毒性及び虚血からなる群から選択される疾患の治療のため、抗コネクシン剤として使用するためのフレカイニド。
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