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Retigabine Efficacy and Safety Trial for Partial Onset Refractory Seizures in Epilepsy (RESTORE2)

2017年3月23日 更新者：GlaxoSmithKline

Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase 3 Study - Determine Efficacy and Safety of Two Doses of Retigabine (900 Mg/Day and 600 Mg/Day) Used as Adjunctive Therapy in Refractory Epilepsy Patients With Partial-Onset Seizures

This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 900 mg/day and 600 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs).

調査の概要

状態

完了

条件

介入・治療

詳細な説明

This Phase 3 study is being conducted in Europe, Israel, Australia, and South Africa to evaluate the efficacy and safety of retigabine dosed at 900 mg/day and 600 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs). The primary objective is to demonstrate a superior change in total partial seizure frequency for four weeks from baseline to the double-blind period. The proportion of responders (greater than or equal to 50% reduction in seizure frequency for four weeks from baseline to the double-blind period) will also be evaluated.

研究の種類

介入

入学 (実際)

539

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Maryland
      • Bethesda、Maryland、アメリカ、20817
        • Mid-Atlantic Epilepsy and Sleep Center
    • Texas
      • Dallas、Texas、アメリカ、75230
        • Neurological Clinic-Texas
  • イギリス
      • Blackpool、イギリス、LANARK FY3 8BP
        • Fylde Coast Hospital
      • Glasgow、イギリス、G11 6NT
        • Western Infirmary (Epilepsy)
      • Liverpool、イギリス、L9 7LJ
        • Walton Centre for Neurology & Neurosurgery
      • London、イギリス、GT LON E1 1BB
        • Royal London Hospital
    • Mersyd
      • Middlesbrough、Mersyd、イギリス、T&W TS4 3BW
        • The James Cook University Hospital
  • イスラエル
      • Ashkelon、イスラエル、78306
        • Barzilai Medical Center
      • Beer Yaakov、イスラエル、70300
        • Assaf Harofeh Medical Center
      • Haifa、イスラエル、31096
        • Rambam Medical Center
      • Holon、イスラエル、58100
        • Wolfson Medical Center
      • Nahariya、イスラエル、22100
        • Western Galilee Hospital
      • Ramat Gan、イスラエル、52621
        • Chaim Sheba Medical Center
      • Rechovot、イスラエル、76100
        • Kaplan Medical Center
      • Tel Aviv、イスラエル、64239
        • Tel-Aviv Sourasky Medical Center
  • ウクライナ
      • Dnepropetrovsk、ウクライナ、49616
        • Psychosomatic Center of Dnepropetr. Regional Clinic
      • Kharkiv、ウクライナ、61022
        • Kharkiv State Medical University
      • Kharkov、ウクライナ、61068
        • Institute of Neurology, Psychiatry and Narcology of AMS, Ukr
      • Kiev、ウクライナ、04080
        • Epilepsy Center of Municipal Clinical Psychoneurological Hospital
      • Odessa、ウクライナ、65025
        • Odessa regional clinical Hospital
  • オーストラリア
    • New South Wales
      • Camperdown、New South Wales、オーストラリア、2050
        • Royal Prince Alfred Hospital
    • Queensland
      • Maroochydore、Queensland、オーストラリア、4558
        • North Coast Neurology Centre
    • Victoria
      • Clayton、Victoria、オーストラリア、3168
        • Monash Medical Centre
      • Parkville、Victoria、オーストラリア、3050
        • Royal Melbourne Hospital
      • West Heidelberg、Victoria、オーストラリア、3084
        • Austin & Repatriation Medical Centre
  • スペイン
      • Barcelona、スペイン、08025
        • Hospital de la Santa Creu i Sant Pau
      • Bilbao、スペイン、48903
        • Hospital de Cruces
      • Granada、スペイン、18013
        • Hosp. Virgen de las Nieves
      • Madrid、スペイン、28034
        • Hospital Ruber Internacional de Madrid
      • San Sebastian、スペイン、20014
        • Hosp de Donostia
      • Zaragoza、スペイン、50009
        • Hosp. Clinico Univ. Lozano Blesa
  • ドイツ
      • Bonn、ドイツ、D-53105
        • University of Bonn -- Department for Epileptplogy
      • Erlangen、ドイツ、BY 91054
        • Zentrum Epilepsie Erlangen (ZEE) der Universitaet Erlangen
      • Goettingen、ドイツ、NI 37075
        • Georg-August-Universitaet Goettingen
      • Mainz、ドイツ、RP 55101
        • Universitaetsklinik Mainz Neurologische Klinik
      • Marburg、ドイツ、HE 35033
        • Universitaet Giessen / Marburg Neurologie
      • Munich、ドイツ、BY 80333
        • Theatinerstrasse 44
      • Ulm、ドイツ、BW 89081
        • Universitaetsklinikum Ulm
  • ハンガリー
      • Budapest、ハンガリー、1145
        • Országos Idegsebészeti Tudományos Intézet
      • Budapest、ハンガリー、1021
        • Natl. Inst. of Psychiatry and Neurology
  • フランス
      • Rennes Cedex、フランス、35033
        • CHU Pontchaillou
      • Strasbourg、フランス、67 67091
        • Hopital Civil de strasbourg
      • Tain L'Hermitage、フランス、26 26600
        • Centre Medical de La Teppe
    • Lyonnais
      • Lyon、Lyonnais、フランス、69003
        • Hôpital Neurologique Pierre Wertheimer
  • ベルギー
      • Antwerp、ベルギー、2020
        • A. Z. Middelheim -- Department of Neurology
      • Brugge、ベルギー、8000
        • AZ Sint-Jan
      • Leuven、ベルギー、3000
        • Universitaire Ziekenhuizen Gasthuisberg -- Department Neurology
      • Ottignies、ベルギー、1340
        • Centre Neurologique William Lennox
  • ポーランド
      • Bialystok、ポーランド、15-420
        • NZOZ Przychodnia Internistyczno - Stomatologiczna "Kendron"
      • Gdansk、ポーランド、80-803
        • Wojewodzki Szpital Specjalistyczny im.Mikolaja Kopernika
      • Katowice、ポーランド、40-752
        • Katedra i Klinika Neurologii Slaskiej Akademii Medycznej
      • Lublin、ポーランド、20-718
        • WSS im.Kardynala S. Wyszynskiego
      • Warsaw、ポーランド、02-957
        • Instytut Psychiatrii i Neurologii II Oddzial Neurologii
      • Warsaw、ポーランド、03-464
        • Prywatna Wielospecjalistyczna Lecznica Medyczna "Zycie"
    • Plock
      • Padlewskiego 4、Plock、ポーランド、09-402
        • Specjalistyczna Przychodnia Lekarska Medikard
  • ロシア連邦
      • Kazan、ロシア連邦、420048
        • Interregional Clinical Diagnostic Centre
      • Moscow、ロシア連邦、117049
        • City hospital # 1
      • Moscow、ロシア連邦、119021
        • Clinic of Nervous Diseases of Sechenov's Moscow Med. Academy
      • Moscow、ロシア連邦、121374
        • District Antiepileptic Centre City Clinical Hospital # 71
      • St. Petersburg、ロシア連邦、194044
        • Military Medical Academy n.a. S.M.Kirov
      • St. Petersburg、ロシア連邦、197022
        • St.Petersburg State Medical University n.a. I.P.Pavlov
  • 南アフリカ
      • Cape Town、南アフリカ、7550
        • Panorama Medi-Clinic
    • East Cape
      • Port Elizabeth、East Cape、南アフリカ、6001
        • Triple M Research
    • Gauten
      • Johannesburg、Gauten、南アフリカ、2193
        • Johannesburg Hospital
    • Gauteng
      • Bloemfontein、Gauteng、南アフリカ、9300
        • University of The Free State
      • Pretoria、Gauteng、南アフリカ、0041
        • Wilgers MR & Medical Centre
      • Sunninghill、Gauteng、南アフリカ、2157
        • Sunninghill & Kopano Clinical Trials
    • KwaZulu-Natal
      • Durban、KwaZulu-Natal、南アフリカ、4091
        • Inkosi Albert Luthuli Central Hospital
    • West Cape
      • Belville、West Cape、南アフリカ、7531
        • Carl Bremer Hospital
    • Western Cape
      • Cape Town、Western Cape、南アフリカ、7925
        • Groote Schuur Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～75年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Diagnosis of refractory epilepsy with simple or complex partial onset seizures with or without secondary generalization
  • 28-day partial seizure frequency rate of four or more partial seizures over the 8-week baseline phase
  • Currently treated with up to three established AEDs
  • Vagal Nerve Stimulator may be included

Exclusion Criteria:

  • Existing medical or psychiatric condition which could affect patient's health or compromise ability to participate in the study
  • Clinically significant abnormalities on physical exam, vital signs, ECG, or liver function tests
  • Impaired renal function (creatinine clearance less than 50 mL/minute)
  • Evidence of progressive central nervous disease, lesion, or encephalopathy
  • History of primary generalized seizures
  • History of clustering or flurries or status epilepticus within 12 months of study entry

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：プラセボ
薬：プラセボ
経口錠剤。
実験的：Retigabine 600 mg
薬：Retigabine
Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 3, patients will enter a 12 week maintenance phase.
他の名前：
  • GKE-841
  • D-23129
薬：Retigabine
Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 5, patients will enter a 12 week maintenance phase.
他の名前：
  • GKE-841
  • D-23129
実験的：Retigabine 900 mg
薬：Retigabine
Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 3, patients will enter a 12 week maintenance phase.
他の名前：
  • GKE-841
  • D-23129
薬：Retigabine
Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 5, patients will enter a 12 week maintenance phase.
他の名前：
  • GKE-841
  • D-23129

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Percent Change in the 28-day Total Partial Seizure (PS) Frequency From Baseline (BL) to the End of the Double-blind (DB) Phase (Titration and Maintenance Phases)
時間枠：Baseline (Week -7 through Week 0), DB Phase (Week 1 through Week 16)
28-day total PS (PSs [also called focal seizures] are seizures limited to a specific area of the brain) frequency in the BL period = (Number [No.] of total PSs reported in the BL period divided by the No. of days of available total PS data in the BL period) x 28 days. 28-day total PS frequency in the DB period = (No. of total PSs reported in the DB period divided by the No. of days of available total PS data in the DB period) x 28 days. Percent change = ([value in the DB period minus value at BL] divided by the BL value) x 100%. Negative valu es indicate a reduction in seizure frequency.
Baseline (Week -7 through Week 0), DB Phase (Week 1 through Week 16)
Number of Participants Classified as Responders and Non-responders During the Maintenance Phase
時間枠：Week 5 through Week 16
Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the Maintenance Phase as compared to the Baseline period.
Week 5 through Week 16

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of Participants Who Were Responders and Non-responders During the DB Phase
時間枠：Week 1 through Week 16
Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the DB Phase as compared to the Baseline period. Participants without any post-baseline data were considered non-responders.
Week 1 through Week 16
Percent Change From Baseline (BL) in the 28-day Total Partial Seizure Frequency During the Maintenance Phase
時間枠：Baseline (Week -7 through Week 0), Week 5 through Week 16
28-day total partial seizure frequency in the BL period = (No. of total partial seizures reported in the BL period divided by the No. of days of available total partial seizure data in the BL period) x 28 days. 28-day total partial seizure frequency in the Maintenance Phase = (No. of total partial seizures reported in the Maintenance Phase divided by the No. of days of available total partial seizure data in the same phase) x 28 days. Percent change = (value in the Maintenance Phase minus value at BL divided by the BL value) x 100%. Negative values indicate a reduction in seizure frequency.
Baseline (Week -7 through Week 0), Week 5 through Week 16
Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the End of DB Phase (Titration and Maintenance Phases) by Indicated Quartile Reduction Categories
時間枠：Baseline (Week -7 through Week 0), Week 1 through Week 16
Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a reduction of 75-100%, 50-<75%, 25-<50%, or <25%, in addition to having no reduction. This quartile cutting was specified in the study protocol. Participants without any post-baseline data are included in the "No reduction" category.
Baseline (Week -7 through Week 0), Week 1 through Week 16
Number of Participants With a Reduction in the 28-day Total Partial Seizure Frequency From Baseline to the DB Phase (Titration and Maintenance Phases) by Indicated Decile Reduction and Increase Categories
時間枠：Baseline (Week -7 through Week 0), Week 1 through Week 16
Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized in decile cutting, i.e., reduction categories of 90-100%, 80-<90%, 70-<80%, 60-<70%, 50-<60%, 40-<50%, 30-<40%, 20-<30%, 10-<20%, >0-<10%, and increase categories of 0-10%, >10-20%, >20-30%, >30% (FDA endpoint). Participants without any post-baseline data were included in the category 0-10% increase category.
Baseline (Week -7 through Week 0), Week 1 through Week 16
Number of Participants With the Indicated Reduction From Baseline in the 28-day Total Partial Seizure Frequency During the Maintenance Phase
時間枠：Baseline (Week -7 through Week 0), Week 5 through Week 16
Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a >75%, a 50-75%, or a <50% reduction, in addition to having no reduction (EMEA endpoint).
Baseline (Week -7 through Week 0), Week 5 through Week 16
Number of Participants Who Experienced the Indicated Level of Exacerbation and Reduction in the 28-day Total Partial Seizure Frequency From Baseline During the Maintenance Phase
時間枠：Baseline (Week -7 through Week 0), Week 5 through Week 16
Participants who experienced an exacerbation from Baseline in the 28-day total partial seizure frequency were categorized as having a 0-25% or a >25% increase (EMEA endpoint). The number of participants experiencing a >0% reduction from Baseline in the 28-day total partial seizure frequency are also presented.
Baseline (Week -7 through Week 0), Week 5 through Week 16
Number of Participants Reporting New Seizure Types in the Indicated Categories During the DB Phase (Titration and Maintenance Phases) That Were Not Reported at Baseline
時間枠：Baseline (Week -7 through Week 0), Week 1 through Week 16
New seizure types included those seizures which were not reported by any participant at Baseline.
Baseline (Week -7 through Week 0), Week 1 through Week 16
Number of Participants Who Were Seizure-free During the DB Phase (Titration and Maintenance Phases)
時間枠：Week 1 through Week 16
Participants were considered to be seizure-free if they had not reported any seizures during the DB treatment period (Weeks 1-18). For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18.
Week 1 through Week 16
Number of Participants Who Were Seizure-free During the Maintenance Phase
時間枠：Week 5 through Week 16
Participants were considered to be seizure-free if they had not reported any seizures during the Maintenance Phase.
Week 5 through Week 16
Percentage of Seizure-free Days During the DB Phase (Titration and Maintenance Phases)
時間枠：Week 1 through Week 16
A seizure-free day was a day without any seizures. For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18. The percentage of seizure-free days was calculated as the total number of days without seizures in the DB period divided by the number of days in DB period x 100%.
Week 1 through Week 16
Percentage of Seizure-free Days During the Maintenance Phase
時間枠：Week 5 through Week 16
A seizure-free day was a day without any seizures. The percentage of seizure-free days was calculated as the total number of days without seizures in the Maintenance Phase divided by the number of days in the Maintenance Phase x 100%.
Week 5 through Week 16
Clinical Global Impression-Improvement (CGI-I) Score at the End of the Maintenance Phase
時間枠：Week 16/end of treatment phase
Clinical Global Impression of Improvement (CGI-I) is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the treatment. Scores on the scale are rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Week 16/end of treatment phase
Patient Global Impression (PGI) Score at the End of the Maintenance Phase
時間枠：Week 16/end of treatment phase
PGI is a participant-rated scale of improvement that was administered at the end of the Maintenance Phase in order to assess the participant's impression of his or her own improvement. PGI assessments were scored using a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Week 16/end of treatment phase
Quality of Life Assessed by Quality of Life in Epilepsy-Problems Questionnaire (QOLIE-31-P) at BL (Week 0) and Weeks 4, 8, and 16
時間枠：End of Baseline (Week 0), Weeks 4, 8, and 16
The QOLIE-31-P is a 31-item questionnaire evaluating a participant's QOL perception in 7 domains: seizure worry, emotional well being, energy/fatigue, cognitive functioning, medication effects, social functioning, overall QOL. Precoded numeric values for some domains are such that a higher number reflects a more favorable health state; others are such that a higher number reflects a less favorable state. Precoded values are first converted to 0-100 point scores; higher converted scores always reflect better QOL. The overall score is derived by weighting and then summing the 7 domain scores.
End of Baseline (Week 0), Weeks 4, 8, and 16
Number of Participants Whose Clinical Laboratory Values Were Deemed an Adverse Event by the Investigator (>=2% in Any Treatment Arm)
時間枠：Week 1 through Week 16
Clinically important changes in laboratory values were to be reported as an adverse event if they met one of the following criteria: (1) intervention required; (2) change in dose of study drug required; (3) other treatment/therapy required; (4) association with other diagnoses.
Week 1 through Week 16
Number of Participants Who Reported the Indicated Renal and Urinary Disorder Adverse Events at a Frequency Threshold of 2% (in Any Treatment Arm)
時間枠：Week 1 through Week 16
A summary of the adverse events classified as renal or urinary disorders and in which at least 2% (rounded to an integer) of participants in any treatment arm reported during the study is presented.
Week 1 through Week 16
Change From Baseline in Post-void Residual Urine Volume at Weeks 8 and 16 of the Maintenance Phase
時間枠：Baseline (Week -7 through 0), Weeks 8 and 16
Post-void residual (PVR) urine refers to the amount of urine remaining in the bladder after normal urination. To investigate the possible effects of retigabine on bladder function, all participants underwent post-void residual bladder ultrasound at Baseline and during the Maintenance Phase. The PVR bladder ultrasound was performed by a urologist, a qualified ultrasound technician, or a qualified study nurse who was certified to do PVR bladder ultrasound. Change from Baseline in PVR residual volume was calculated as the values at Week 10 and Week 16 minus the value at Baseline.
Baseline (Week -7 through 0), Weeks 8 and 16
Number of Participants With a >=7% Increase in Body Weight During Weeks 2 and 4 of theTitration Phase and Weeks 6, 8, 12, and 16 of the Maintenance Phase
時間枠：Weeks 2 and 4 of Titration Phase and Weeks 6, 8, 12, and 16 of Maintenance Phase
The number of participants with recorded weight gain of >=7% over their baseline weight was measured.
Weeks 2 and 4 of Titration Phase and Weeks 6, 8, 12, and 16 of Maintenance Phase

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

GlaxoSmithKline

協力者

Bausch Health Americas, Inc.

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2005年12月1日

一次修了 (実際)

2008年4月1日

研究の完了 (実際)

2008年4月1日

試験登録日

最初に提出

2005年10月6日

QC基準を満たした最初の提出物

2005年10月6日

最初の投稿 (見積もり)

2005年10月10日

学習記録の更新

投稿された最後の更新 (実際)

2017年4月21日

QC基準を満たした最後の更新が送信されました

2017年3月23日

最終確認日

2017年3月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • VRX-RET-E22-302

個々の参加者データ (IPD) の計画

試験データ・資料

  1. 研究プロトコル
    情報識別子：VRX-RET-E22-302
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  2. 個人参加者データセット
    情報識別子：VRX-RET-E22-302
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  3. 注釈付き症例報告書
    情報識別子：VRX-RET-E22-302
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  4. 臨床研究報告書
    情報識別子：VRX-RET-E22-302
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  5. 統計分析計画
    情報識別子：VRX-RET-E22-302
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  6. データセット仕様
    情報識別子：VRX-RET-E22-302
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register
  7. インフォームド コンセント フォーム
    情報識別子：VRX-RET-E22-302
    情報コメント：For additional information about this study please refer to the GSK Clinical Study Register

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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