JP2022064988A - カンナビジオールによる脆弱x症候群の処置 - Google Patents
カンナビジオールによる脆弱x症候群の処置 Download PDFInfo
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- A61K31/00—Medicinal preparations containing organic active ingredients
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Abstract
Description
本願は、2017年9月28日に出願された米国仮出願第62/564,834号及び2018年2月20日に出願された米国仮出願第62/632,532号の利益及び優先権を主張する。これらの各々の内容は、その全体が、参照により本明細書に組み込まれる。
合計20人の患者(平均年齢=10.8、標準偏差=4.0)が、12週の研究に参加した。FMR1全変異の分子的記録によって確認された、脆弱Xを有する6~17歳の年齢(平均=11.2、標準偏差=3.96)の患者18人(男性14人、女性4人)が、12週を通じて、非盲検でのFAB-C研究を終了した。投与されている他の医薬にCBDゲルを添加した。研究の最初の6週は、患者における投薬を用量設定するように設計された。投薬は、1日に50mgCBDで開始され、1日に250mgCBDまで増加することができた。研究の7~12週は、6週までに、1日に最大250mgCBDに確立された用量で患者が処置された維持期間から構成された。研究の完了時に、患者は、最大12ヶ月間の非盲検延長研究に入ることができた。
これは、介護者によって報告された、上記研究に参加し、延長研究を継続している7歳児に関する報告である。介護者の息子は、全変異脆弱X症候群を有している。彼は、本試験の前に、言葉を使わず、重度の知的障害、視覚的障害があり、未だおむつが必要で、2時間ごとに栄養管によって栄養補給する必要がある極めて重度の胃腸の問題を有していると報告されている。本試験を開始する前に、この小児は、アイコンタクトをしたことが全くなく、著しい精神的苦痛なしに家から外出できることは稀であり、何らかの形態の意思疎通を開始することは全くなく、両親を含めて触られることを極度に嫌い、家族でさえ隣に座ることを許さず、誰かが部屋の中に歩いて入ると部屋を出て行った。
Claims (31)
- 対象中の脆弱X症候群の1つ以上の行動上の症状を処置する方法であって、カンナビジオール(CBD)の有効量を対象に経皮的に投与することを含み、脆弱X症候群の1つ以上の行動上の症状が対象において処置される、方法。
- CBDが(-)-CBDである、請求項1に記載の方法。
- CBDの有効量が、1日に合計約50mg~約500mgの間である、請求項1に記載の方法。
- CBDの有効量が1日に50mgで開始され、1日に500mgまで用量設定される、請求項1に記載の方法。
- CBDの有効量が1日に50mgで開始され、1日に250mgまで用量設定される、請求項1に記載の方法。
- CBDの有効量が、1日に250mgで開始される、請求項1に記載の方法。
- CBDの有効量が、1日に500mgで開始される、請求項1に記載の方法。
- CBDがゲルとして処方される、請求項1に記載の方法。
- CBDが、浸透亢進ゲルとして処方される、請求項8に記載の方法。
- CBDが1日単回投与量として投与される、請求項1に記載の方法。
- CBDが1日2回投与量としてとして投与される、請求項1に記載の方法。
- 脆弱X症候群の1つ以上の行動上の症状を緩和することが、不安、抑うつ及び気分尺度(ADAMS)の総スコアの改善を含む、請求項1に記載の方法。
- 脆弱X症候群の1つ以上の行動上の症状を緩和することが、脆弱Xのための異常行動チェックリスト(ABC-FXS)の1つ以上の指標の改善を含む、請求項1に記載の方法。
- 1つ以上の行動上の症状が、全般性不安、社会的回避、強迫行動、躁病的/多動行動、易刺激性、嗜眠、常同及び不適切な発話からなる群から選択される、請求項1に記載の方法。
- 緩和される行動上の症状が全般性不安である、請求項1に記載の方法。
- 緩和される行動上の症状が社会的回避である、請求項1に記載の方法。
- 緩和される行動上の症状が強迫行動である、請求項1に記載の方法。
- 緩和される行動上の症状が躁病的/多動行動である、請求項1に記載の方法。
- 緩和される行動上の症状が易刺激性である、請求項1に記載の方法。
- 緩和される行動上の症状が嗜眠である、請求項1に記載の方法。
- 緩和される行動上の症状が無応答性である、請求項1に記載の方法。
- 緩和される行動上の症状が常同である、請求項1に記載の方法。
- 緩和される行動上の症状が不適切な発話である、請求項1に記載の方法。
- 緩和される行動上の症状が癇癪/気分変動である、請求項1に記載の方法。
- 緩和される行動上の症状が多動性/衝動性である、請求項1に記載の方法。
- CBDが、対象の腕に経皮的に投与される、請求項1に記載の方法。
- CBDが合成CBDである、請求項1に記載の方法。
- CBDが精製されたCBDである、請求項1に記載の方法。
- CBDが植物に由来する、請求項1に記載の方法。
- カンナビジオール(CBD)の有効量を経皮的に投与することが、CBDを経口的に投与することと比べて、少なくとも1つの有害事象の強度を低減する、請求項1に記載の方法。
- 少なくとも1つの有害事象が、傾眠、精神賦活効果、肝機能及び胃腸関連有害事象からなる群から選択される、請求項30に記載の方法。
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
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US201762564834P | 2017-09-28 | 2017-09-28 | |
US62/564,834 | 2017-09-28 | ||
US201862632532P | 2018-02-20 | 2018-02-20 | |
US62/632,532 | 2018-02-20 | ||
JP2020517930A JP7210564B2 (ja) | 2017-09-28 | 2018-09-27 | カンナビジオールによる脆弱x症候群の処置 |
PCT/IB2018/057519 WO2019064234A1 (en) | 2017-09-28 | 2018-09-27 | TREATMENT OF FRAGILE X SYNDROME WITH CANNABIDIOL |
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JP2020517930A Division JP7210564B2 (ja) | 2017-09-28 | 2018-09-27 | カンナビジオールによる脆弱x症候群の処置 |
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JP2022015432A Pending JP2022064988A (ja) | 2017-09-28 | 2022-02-03 | カンナビジオールによる脆弱x症候群の処置 |
JP2023001500A Pending JP2023040166A (ja) | 2017-09-28 | 2023-01-10 | カンナビジオールによる脆弱x症候群の処置 |
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US (11) | US10213390B1 (ja) |
EP (2) | EP3687513B1 (ja) |
JP (3) | JP7210564B2 (ja) |
KR (2) | KR20220045070A (ja) |
AU (1) | AU2018343256A1 (ja) |
BR (1) | BR112020005918A2 (ja) |
CA (1) | CA3077330A1 (ja) |
CY (1) | CY1125071T1 (ja) |
DK (1) | DK3687513T3 (ja) |
ES (1) | ES2907325T3 (ja) |
HR (1) | HRP20220277T1 (ja) |
HU (1) | HUE058102T2 (ja) |
IL (1) | IL273495A (ja) |
JO (1) | JOP20200082A1 (ja) |
LT (1) | LT3687513T (ja) |
MX (2) | MX2020003606A (ja) |
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RS (1) | RS62969B1 (ja) |
SI (1) | SI3687513T1 (ja) |
WO (1) | WO2019064234A1 (ja) |
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HUE058102T2 (hu) | 2017-09-28 | 2022-07-28 | Zynerba Pharmaceuticals Inc | Fragilis X szindróma és autizmus kezelése kannabidiollal |
GB201912760D0 (en) * | 2019-09-05 | 2019-10-23 | Healx Ltd | Treatment |
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