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再発寛解型多発性硬化症（RRMS）の小児被験者におけるBG00012の第3相有効性および安全性研究 (CONNECT)

2026年5月16日 更新者：Biogen

再発寛解型多発性硬化症の 10 歳から 18 歳未満の小児における BG00012 の非盲検、無作為化、多施設、複数回投与、実薬対照、並行群間、有効性および安全性試験、任意の非盲検延長を伴う

パート 1 の主な目的は次のとおりです。RRMS の小児被験者における BG00012 の安全性、忍容性、および有効性を、疾患修飾治療と比較して評価し、健康転帰および障害の進行を評価すること。 パート 2 の主な目的は、試験 109MS306 のパート 1 で 96 週を完了した被験者における BG00012 の長期的な安全性を評価することです。 パート 2 の第 2 の目的は、研究 109MS306 のパート 1 で 96 週を完了した被験者における BG00012 の長期 MS アウトカムを説明することです。

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

156

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
    • Massachusetts
      • Boston、Massachusetts、アメリカ、2115
        • Boston Children's Hospital
    • Virginia
      • Charlottesville、Virginia、アメリカ、22903
        • The Rector and Visitors of the University of Virginia
  • イギリス
    • Greater London
      • London、Greater London、イギリス、WC1N 3BG
        • The National Hospital for Neurology & Neurosurgery
      • London、Greater London、イギリス、WC1N 3JH
        • Great Ormond Street Hospital for Children
      • London、Greater London、イギリス、SE1 7EH
        • Evelina London Children's Hospital
    • West Midlands
      • Birmingham、West Midlands、イギリス、B4 6NH
        • Birmingham Children's Hospital
  • イスラエル
      • Jerusalem、イスラエル、91120
        • Hadassah University Hospital - Ein Kerem
      • Petah Tikva、イスラエル、4920235
        • Schneider Children's Medical Center
      • Ramat Gan、イスラエル、5265601
        • Chaim Sheba Medical Center
  • イタリア
      • Bari、イタリア、70124
        • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
      • Genova、イタリア、16132
        • IRCCS Ospedale Policlinico San Martino
      • Milan、イタリア、20132
        • Ospedale San Raffaele
      • Naples、イタリア、80131
        • Azienda Ospedaliera Universitaria 'Federico II'
      • Padova、イタリア、35128
        • Azienda Ospedale-Università di Padova
      • Palermo、イタリア、90127
        • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
      • Roma、イタリア、00189
        • Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
      • Roma、イタリア、00165
        • Ospedale Pediatrico Bambino Gesu
    • Varese
      • Gallarate、Varese、イタリア、21013
        • Azienda Socio Sanitaria Territoriale della Valle Olona (presidio di Gallarate)
  • カナダ
    • Alberta
      • Calgary、Alberta、カナダ、T3B 6A8
        • University of Calgary - Alberta Children's Hospital
  • クウェート
      • Ash Shuwaykh、クウェート、12345
        • Ibn Sina Hospital
  • スウェーデン
      • Gothenburg、スウェーデン、41345
        • Sahlgrenska Sjukhuset
      • Stockholm、スウェーデン、SE-113 61
        • Karolinska
  • スペイン
      • Seville、スペイン、41009
        • Hospital Universitario Virgen Macarena
    • Barcelona
      • Esplugues de Llobregat、Barcelona、スペイン、8950
        • Hospital Sant Joan de Déu
    • Córdoba
      • Córdoba、Córdoba、スペイン、14011
        • Hospital Universitario Reina Sofia
    • Madrid
      • Torrejón de Ardoz、Madrid、スペイン、28850
        • Hospital Universitario De Torrejon
  • セルビア
      • Belgrade、セルビア、11000
        • Clinic of Neurology and Psychiatry for Children and Youth
      • Belgrade、セルビア、11000
        • Mother and Child Health Care Institute of Serbia ,,Dr Vukan Cupic''
      • Kragujevac、セルビア、34000
        • University Clinical Center Kragujevac
  • チェコ
      • Brno、チェコ、656 91
        • Fakultni nemocnice u sv. Anny v Brne
      • Hradec Králové、チェコ、500 05
        • Fakultni nemocnice Hradec Kralove
      • Jihlava、チェコ、58633
        • Nemocnice Jihlava p.o.
      • Ostrava、チェコ、708 52
        • Fakultni Nemocnice Ostrava
  • デンマーク
      • Aarhus N、デンマーク、8200
        • Århus Universitetshospital
      • Copenhagen、デンマーク、2100
        • Rigshospitalet
      • Odense、デンマーク、5000
        • Odense Universitetshospital
  • トルコ（Türkiye）
      • Ankara、トルコ（Türkiye）、06100
        • Hacettepe University Medical Faculty
      • Antalya、トルコ（Türkiye）、07070
        • Akdeniz University Faculty of Medicine
  • ドイツ
    • Bavaria
      • Augsburg、Bavaria、ドイツ、86156
        • Universitaetsklinikum Augsburg
      • Munich、Bavaria、ドイツ、80337
        • Klinikum der Universitaet Muenchen
    • North Rhine-Westphalia
      • Bochum、North Rhine-Westphalia、ドイツ、44791
        • Katholisches Klinikum Bochum gGmbH
  • ハンガリー
      • Budapest、ハンガリー、1083
        • Semmelweis Egyetem
      • Budapest、ハンガリー、1089
        • Heim Pal Orszagos Gyermekgyogyaszati Intezet
  • フランス
    • Bas Rhin
      • Strasbourg、Bas Rhin、フランス、67098
        • CHU Strasbourg - Hôpital Hautepierre
    • Bouches-du-Rhône
      • Marseille、Bouches-du-Rhône、フランス、13385
        • Hôpital de la Timone
    • Côte-d'Or
      • Dijon、Côte-d'Or、フランス、21079
        • CHU Dijon -BOCAGE CENTRAL
    • Herault
      • Montpellier、Herault、フランス、34295
        • Hôpital Gui de Chauliac
    • Ille Et Vilaine
      • Rennes、Ille Et Vilaine、フランス、35033
        • CHU Rennes - Hôpital Pontchaillou
    • Meurthe Et Moselle
      • Vandœuvre-lès-Nancy、Meurthe Et Moselle、フランス、54500
        • Hôpital de Brabois Enfants
    • Nord
      • Lille、Nord、フランス、59037
        • Hopital Roger Salengro - CHU Lille
    • Puy De Dome
      • Clermont-Ferrand、Puy De Dome、フランス、63003
        • CHU Clermont Ferrand - Hopital d'Estaing
    • Rhone
      • Bron、Rhone、フランス、69677
        • Hopital Neurologique Pierre Wertheimer
    • Somme
      • Amiens、Somme、フランス、80054
        • CHU Amiens - Hopital Sud
    • Val De Marne
      • Le Kremlin-Bicêtre、Val De Marne、フランス、94275
        • Hôpital Bicêtre
  • ブルガリア
      • Sofia、ブルガリア、1113
        • MHATNP 'Sv.Naum', EAD
  • ベルギー
      • Brussels、ベルギー、1020
        • Universitair Kinderziekenhuis Koningin Fabiola
      • Ghent、ベルギー、9000
        • Universitair Ziekenhuis Ghent
  • ポーランド
      • Bialystok、ポーランド、15-274
        • SPZOZ Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa
      • Gdansk、ポーランド、80-211
        • Uniwersyteckie Centrum Kliniczne
      • Lodz、ポーランド、93-338
        • Instytut Centrum Zdrowia Matki Polki
      • Poznan、ポーランド、60-355
        • Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu
      • Warsaw、ポーランド、04-730
        • Instytut 'Pomnik - Centrum Zdrowia Dziecka'

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

10年～17年 (子)

健康ボランティアの受け入れ

いいえ

説明

主な採用基準:

  • 体重が30kg以上あること。
  • -RRMSの診断を受けている必要があります（小児RRMSのコンセンサス定義[Krupp 2007]）。
  • -ベースラインのEDSSスコアが0〜5.5の歩行可能である必要があります。
  • -次の3つの状態のうち少なくとも1つを経験している必要があります：a）1日目の前の過去12か月以内に少なくとも1回の再発で、MSと一致する病変を示す以前の脳MRI; b) 1 日目より前の過去 24 か月以内に少なくとも 2 回の再発があり、以前の脳 MRI で MS と一致する病変が示されている; c) 1日目前の6週間以内に実施されたMRIでの脳のGd増強病変の証拠。
  • -神経学的に安定している必要があり、1日目の前50日以内に再発の証拠がなく、1日目の前30日以内にコルチコステロイド治療の証拠がない.
  • -性的に活発な出産の可能性のある被験者は、研究中に効果的な避妊を実践する意思があり、研究治療の最終投与後少なくとも30日間は避妊を続ける意思と能力がなければなりません。

主な除外基準:

  • 一次進行性、二次進行性、または進行性再発 MS ([Lublin and Reingold 1996] で定義)。 これらの状態では、少なくとも 3 か月間継続して臨床的疾患が悪化している必要があります。 これらの状態を有する被験者は、再発を重ねる場合もありますが、臨床的に安定した期間または臨床的改善がないことにより、再発寛解被験者と区別されます。
  • 他の脱髄性疾患（例：急性播種性脳脊髄炎）、全身性自己免疫疾患（例：シェーグレン病、エリテマトーデス）、代謝性疾患（例：ジストロフィー）、および感染性疾患など、MSに似た疾患。
  • -前癌性または悪性疾患の病歴。 スクリーニング前に完全に切除された基底細胞癌の被験者は、引き続き適格です。
  • -重度のアレルギー反応またはアナフィラキシー反応の病歴、またはDMF、フマル酸エステル、またはインターフェロンベータ-1a（IFNベータ-1a）に対する既知の薬物過敏症。
  • -重大な内分泌、血液、肝臓、免疫、代謝、泌尿器、腎臓、および/または臨床研究への参加を妨げるその他の主要な疾患を示す異常な検査結果の履歴。

  • -臨床的に重要な心血管、肺、GI、皮膚、成長、発達、精神（うつ病を含む）、神経（MS以外）、および/または臨床研究への参加を妨げるその他の主要な疾患の病歴。

    ・ヒト免疫不全ウイルスの歴史。

  • -1日目前の50日以内に発生したMSの再発、および/または被験者は、1日目前の以前の再発から安定していません。
  • -治験責任医師またはBiogen Idecの意見では、被験者を登録に不適切にするその他の不特定の理由。
  • 対象の PD/PK サブセットの場合: BG00012 カプセル全体を飲み込むことができない対象。

主な治療歴

  • -Fumaderm（フマル酸エステル）またはBG00012による以前の治療。
  • -次のいずれかによる前治療：リツキシマブまたはナタリズマブを除く、全リンパ球照射、クラドリビン、T細胞またはT細胞受容体ワクチン接種、治療用モノクローナル抗体。
  • -1日目の前の12か月以内に次の薬物療法のいずれかによる以前の治療：ミトキサントロン、シクロホスファミド、リツキシマブ。
  • -1日目の前6か月以内に次のいずれかの薬または手順による前治療：フィンゴリモド。テリフルノミド;ナタリズマブ;シクロスポリン;アザチオプリン;メトトレキサート;ミコフェノール酸モフェチル;ラキニモド;静脈内 (IV) 免疫グロブリン;血漿交換または細胞交換
  • -1日目の前30日以内に次の薬物療法のいずれかによる治療：ステロイド（IVまたは経口コルチコステロイド治療、コルチコステロイド経路を介して作用しない可能性のある薬剤を含む[例：低用量ナルトレキソン]）、4-アミノピリジンまたは関連製品（被験者を除く）制御放出ファンプリジンの安定した用量を3か月間）

注: 他のプロトコル定義の包含/除外基準が適用される場合があります

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：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：BG00012
参加者は、1日2回、経口で240 mgの推奨用量を受け取ります
薬：フマル酸ジメチル
経口投与
他の名前：
  • BG00012
  • テクフィデラ
アクティブコンパレータ：IFN β-1a (アボネックス)
参加者は、推奨用量の30μg（毎週）を受け取ります
薬：インターフェロンβ-1a
筋肉注射による投与
他の名前：
  • アボネックス

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
Part 1: Proportion of Participants Free of New or Newly Enlarging T2 Hyperintense Lesions on Brain Magnetic Resonance Imaging (MRI) Scans
時間枠：At Week 96
Participants who were free of new or newly enlarging T2 hyperintense lesions were assessed on Brain MRI scans.
At Week 96
Part 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
時間枠：From Week 96 up to last follow-up visit (up to Week 340)
An adverse event (AE) was any unfavorable and unintended sign (including an abnormal assessment such as an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE was any untoward medical occurrence that at any dose resulted in death, in the view of the Investigator, placed the participant at immediate risk of death, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a birth defect. TEAEs were defined as AEs occurring or worsening after beginning study treatment (after the first dose).
From Week 96 up to last follow-up visit (up to Week 340)
Part 2: Number of Participants Who Discontinued Study Treatment Due to an AE
時間枠：From Week 96 up to last follow-up visit (up to Week 340)
An AE was any unfavorable and unintended sign (including an abnormal assessment such as an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
From Week 96 up to last follow-up visit (up to Week 340)

二次結果の測定

結果測定
メジャーの説明
時間枠
Part 1: Number of New or Newly Enlarged T2 Hyperintense Lesions on Brain MRI Scans
時間枠：At Weeks 24 and Week 96
The number of new or newly enlarging T2 hyperintense lesions that developed in each participant was assessed on Brain MRI scans.
At Weeks 24 and Week 96
Part 1: Proportion of Participants Free of New or Newly Enlarging T2 Hyperintense Lesions on Brain MRI Scans
時間枠：At Weeks 24 and 48
Participants who were free of new or newly enlarging T2 hyperintense lesions were assessed on Brain MRI scans.
At Weeks 24 and 48
Part 1: Proportion of Participants Free of New MRI Activity as Measured by Brain MRI Scans
時間枠：At Weeks 24, 48, and 96
Participants free of Gd-enhancing MRI lesions and new or newly enlarging T2 MRI lesions were assessed on Brain MRI Scans.
At Weeks 24, 48, and 96
Part 1: Time to First Relapse
時間枠：Up to Week 96
Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. The time to first relapse was defined as the time from the first dose in Part 1 up to the first relapse. Time to First Relapse was estimated by Kaplan-Meier method.
Up to Week 96
Part 1: Proportion of Relapse-Free Participants
時間枠：Up to Week 96
Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. The proportion of relapse-free participants was estimated using the Kaplan-Meier method.
Up to Week 96
Part 1: Annualized Relapse Rate (ARR)
時間枠：At Weeks 48 and 96
ARR is calculated as the total number of relapses that occurred during the study divided by the total number of participant-years. ARR was analyzed using negative binomial regression model.
At Weeks 48 and 96
Part 1: Number of Participants With TEAEs and TESAEs
時間枠：From Day 1 up to Week 96
An AE was any unfavorable and unintended sign (including an abnormal assessment such as an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE was any untoward medical occurrence that at any dose resulted in death, in the view of the Investigator, placed the participant at immediate risk of death, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a birth defect. TEAEs were defined as AEs occurring or worsening after beginning study treatment (after the first dose).
From Day 1 up to Week 96
Part 1: Change From Baseline in Vital Signs (Temperature)
時間枠：Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96
Negative change from baseline indicated reduction in temperature.
Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96
Part 1: Change From Baseline in Vital Signs (Pulse Rate)
時間枠：Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96
Negative change from baseline indicated reduction in pulse rate.
Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96
Part 1: Change From Baseline in Vital Signs (Blood Pressure)
時間枠：Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96
Negative change from baseline indicated reduction in blood pressure.
Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96
Part 1: Change From Baseline in Vital Signs (Respiratory Rate)
時間枠：Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96
Negative change from baseline indicated reduction in respiratory rate.
Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96
Part 1: Number of Participants With Shifts From Baseline in Electrocardiograms (ECG) Abnormalities
時間枠：Up to Week 96
Clinical significance of abnormalities in ECG was determined based on the investigator's discretion. Shift to abnormal indicated values that were normal or unknown at baseline and shifted to abnormal values post-baseline.
Up to Week 96
Part 1: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Hematology Parameters)
時間枠：Baseline up to Week 96
Hematology parameters included leukocytes, erythrocytes, hemoglobin, hematocrit, platelets, eosinophils, lymphocytes, monocytes and neutrophils. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available. Here, shift to low indicated values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicated values that were normal, low or unknown at baseline and shifted to high postbaseline values. The categories with at least one participant with shift from baseline in these parameters are reported.
Baseline up to Week 96
Part 1: Change From Baseline in Coagulation Parameters [Activated Partial Thromboplastin Time (aPTT)]
時間枠：Baseline, Weeks 24, 48 and 96
A negative change from baseline indicated a reduction in aPTT.
Baseline, Weeks 24, 48 and 96
Part 1: Change From Baseline in Coagulation Parameters [Prothrombin Time (PT)]
時間枠：Baseline, Weeks 24, 48 and 96
A negative change from baseline indicated a reduction in PT.
Baseline, Weeks 24, 48 and 96
Part 1: Change From Baseline in Coagulation Parameters [International Normalized Ratio (INR)]
時間枠：Baseline, Weeks 24, 48 and 96
A negative change from baseline indicated a reduction in clotting time.
Baseline, Weeks 24, 48 and 96
Part 1: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Blood Chemistry Parameters)
時間枠：Baseline up to Week 96
Parameters included sodium, potassium, chloride, bilirubin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, urea nitrogen, creatinine, bicarbonate, calcium, magnesium, phosphate, urate and glucose. These parameters were flagged as low, normal or high relative to parameter's normal range or as unknown if no result was available, by Investigator. Here, shift to low indicated values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicated values that were normal, low or unknown at baseline and shifted to high values postbaseline. Categories with at least one participant with shift from baseline in these parameters are reported.
Baseline up to Week 96
Part 1: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Urinalysis Parameters)
時間枠：Baseline up to Week 96
Urinalysis included assessments of glucose, ketones, occult blood, protein, specific gravity. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicated values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicated values that were normal, low or unknown at baseline and shifted to high postbaseline. The categories with at least one participant with shift from baseline in these parameters are reported.
Baseline up to Week 96
Part 1: Fatigue Score Measured by the Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale
時間枠：Up to Week 96
The PedsQL multidimensional fatigue questionnaire was answered by the participant (self-assessment) and parent. The fatigue scale contains 18 questions in 3 fatigue dimensions: general fatigue, sleep/rest fatigue and cognitive fatigue. Each item was scored on 5-point Likert scale (0=never to 4=almost always). Each individual score was then reversed (subtracted from 4) and linearly transformed as follows: 0=100, 1=75, 2=50, 3=25, 4=0. For each dimension, total score was calculated as the sum of all the items/number of items answered. A higher total score indicated fewer problems.
Up to Week 96
Part 1: Quality of Life (QOL) as Measured by the PedsQL
時間枠：Up to Week 96
The PedsQL QOL questionnaire was answered by the participant (self-assessment) and parent. The QoL scale contains 23 questions in 4 dimensions: Physical Functioning, Emotional Fatigue, Social Fatigue and School Fatigue. Each item was scored on 5-point Likert scale (0=never to 4=almost always). Each individual score was then reversed (subtracted from 4) and linearly transformed as follows: 0=100, 1=75, 2=50, 3=25, 4=0. For each dimension, total score was calculated as the sum of all the items/number of items answered. A higher total score indicated better quality of life.
Up to Week 96
Part 1: Change From Baseline in the Expanded Disability Status Scale (EDSS) Score
時間枠：Baseline, Week 96
The EDSS measures the disability status of participants with multiple sclerosis on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The range of main categories include (0) = normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS with higher scores indicating more disability. A negative change from baseline indicated an improvement in the disability.
Baseline, Week 96
Part 2: Annualized Relapse Rate (ARR)
時間枠：From Baseline (Week 96) up to Week 336
ARR is calculated as the total number of relapses that occurred during the study divided by the total number of participant-years. ARR was analyzed using negative binomial regression model.
From Baseline (Week 96) up to Week 336
Part 2: Change From Baseline in the Expanded Disability Status Scale (EDSS) Score
時間枠：Baseline (Week 96), Week 336
The EDSS measures the disability status of participants with multiple sclerosis on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The range of main categories include (0) = normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. A negative change from baseline indicated an improvement in the disability.
Baseline (Week 96), Week 336
Part 2: Change From Baseline in Brief Visuospatial Memory Test - Revised (BVMT-R) Score
時間枠：Baseline (Week 96), Weeks 144,192, 240, 288 and 336
BVMT-R is used to assess learning/memory. In this test, six abstract designs are presented for 10 sec. The display is removed from view, and participants render the stimuli via pencil on paper, manual responses. Each design receives from 0 to 2 points, representing accuracy and location. There are three Learning Trials, and the score is reported as the total number of points earned over the trials. Thus, scores range from 0 to 12 per trial; total score range is 0 to 36 for all three trials. Scores were converted to standardized scores using normative data, ranging from 2-86. The lower the score, the more severe the cognitive impairment while higher scores reflect better visuospatial memory.
Baseline (Week 96), Weeks 144,192, 240, 288 and 336
Part 2: Change From Baseline in Symbol Digit Modalities Test (SDMT) Score
時間枠：Baseline (Week 96), Weeks 144,192, 240, 288 and 336
SDMT is used to assess processing speed. It consists of 9 abstract symbols. Each symbol is paired with a single digit. The participant is provided with a key, showing each symbol digit pair. In addition, the participants are shown several rows of the 9 symbols, which are arranged pseudo-randomly, without the digit. Participants are asked to voice the digit associated with each symbol as rapidly as possible for 90 seconds. The SDMT score ranges from 0 to 110, where higher scores indicate improvement in cognitive functioning and lower scores indicate worsening.
Baseline (Week 96), Weeks 144,192, 240, 288 and 336
Part 2: Number of Participants With or Without School Progression
時間枠：At Weeks 144, 192, 240, 288 and 336
Participants or caregivers were posed the following question: "During the past year, did [you/the participant] progress from one [class/grade-level] to the next in school?" Responses were recorded as Yes (participant advanced to the next grade) or No (participant did not advance).
At Weeks 144, 192, 240, 288 and 336
Part 2: Change From Baseline in Vital Signs (Temperature)
時間枠：Baseline (Week 96), Weeks 120,144, 168, 192, 216, 240, 264, 288, 312, 336, and 340
Negative change from baseline indicated reduction in temperature.
Baseline (Week 96), Weeks 120,144, 168, 192, 216, 240, 264, 288, 312, 336, and 340
Part 2: Change From Baseline in Vital Signs (Pulse Rate)
時間枠：Baseline (Week 96), Weeks 120,144, 168, 192, 216, 240, 264, 288, 312, 336, and 340
Negative change from baseline indicated reduction in pulse rate.
Baseline (Week 96), Weeks 120,144, 168, 192, 216, 240, 264, 288, 312, 336, and 340
Part 2: Change From Baseline in Vital Signs (Blood Pressure)
時間枠：Baseline (Week 96), Weeks 120,144, 168, 192, 216, 240, 264, 288, 312, 336, and 340
Negative change from baseline indicated reduction in blood pressure.
Baseline (Week 96), Weeks 120,144, 168, 192, 216, 240, 264, 288, 312, 336, and 340
Part 2: Change From Baseline in Vital Signs (Respiratory Rate)
時間枠：Baseline (Week 96), Weeks 120,144, 168, 192, 216, 240, 264, 288, 312, 336, and 340
Negative change from baseline indicated reduction in respiratory rate.
Baseline (Week 96), Weeks 120,144, 168, 192, 216, 240, 264, 288, 312, 336, and 340
Part 2: Number of Participants With Shifts From Baseline in ECG Abnormalities
時間枠：From Baseline (Week 96) to Week 336
Clinical significance of abnormalities in ECG was determined based on the investigator's discretion. Shift to abnormal indicated values that were normal or unknown at baseline and shifted to abnormal values post-baseline.
From Baseline (Week 96) to Week 336
Part 2: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Hematology Parameters)
時間枠：Baseline (Week 96) up to Week 340
Hematology parameters included leukocytes, erythrocytes, hemoglobin, hematocrit, platelets, eosinophils, lymphocytes, monocytes and neutrophils. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available. Here, shift to low indicated values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicated values that were normal, low or unknown at baseline and shifted to high postbaseline values. The categories with at least one participant with shift from baseline in these parameters are reported.
Baseline (Week 96) up to Week 340
Part 2: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Blood Chemistry Parameters)
時間枠：Baseline (Week 96) up to Week 340
Parameters included potassium, bilirubin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, urea nitrogen, creatinine, bicarbonate, calcium, magnesium, phosphate, urate and glucose. These parameters were flagged as low, normal or high relative to parameter's normal range or as unknown if no result was available, by Investigator. Here, shift to low indicated values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicated values that were normal, low or unknown at baseline and shifted to high values postbaseline. Categories with at least one participant with shift from baseline in these parameters are reported.
Baseline (Week 96) up to Week 340
Part 2: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Urinalysis Parameters)
時間枠：Baseline up to Week 340
Urinalysis included assessments of erythrocytes, leukocytes and specific gravity. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicated values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicated values that were normal, low or unknown at baseline and shifted to high postbaseline. The categories with at least one participant with shift from baseline in these parameters are reported.
Baseline up to Week 340
Part 2: Change From Baseline in Height
時間枠：Baseline (Week 96), Weeks 120,144, 168, 192, 216, 240, 264, 288, 312, 336, and 340
Baseline (Week 96), Weeks 120,144, 168, 192, 216, 240, 264, 288, 312, 336, and 340
Part 2: Change From Baseline in Weight
時間枠：Baseline (Week 96), Weeks 120,144, 168, 192, 216, 240, 264, 288, 312, 336, and 340
Baseline (Week 96), Weeks 120,144, 168, 192, 216, 240, 264, 288, 312, 336, and 340
Part 2: Change From Baseline in Bone Age
時間枠：Baseline (Week 96), Weeks 144, 192 and 240
Bone age was tested until the participant reached a bone age of 16 years.
Baseline (Week 96), Weeks 144, 192 and 240
Part 2: Number of Male Participants by Tanner Stage Assessment
時間枠：At Weeks 96, 144, 192, 240, 288 and 336
Tanner pubertal staging in males was assessed for testes and scrotum development and pubic hair growth, progressing from stage 1 (prepubertal) to stage 5 (adult). Assessments ended when bone age reached ≥16 years. Testes and scrotum stages were: 1-prepubertal; 2-enlargement of testes, scrotum reddens, texture change; 3-Enlargement of penis, further growth of testes; 4-Increased size of penis with growth in breadth and development of glans; testes and scrotum larger, scrotum skin darker; 5-adult genitalia. Pubic hair stages were: 1-prepubertal; 2-Sparse growth of long, slightly pigmented hair, straight or curled; 3-Darker, coarser and more curled hair, spreading sparsely over junction of pubes; 4-Hair adult in type, but covering smaller area than in adult; no spread to medial surface of thighs; 5-Adult in type and quantity, with horizontal distribution.
At Weeks 96, 144, 192, 240, 288 and 336
Part 2: Number of Female Participants by Tanner Stage Assessment
時間枠：At Weeks 96, 144, 192, 240, 288 and 336
Tanner pubertal staging in females was assessed for breast development and pubic hair growth, progressing from stage 1 (prepubertal) to stage 5 (adult). Assessments ended when bone age reached ≥16 years or the participant was post-menarche. Breast development stages: 1-prepubertal; 2-breast bud stage with elevation of breast and papilla; enlargement of areola, 3-further enlargement of breast and areola; no separation of their contour; 4-areola and papilla form secondary mound above level of breast; 5-mature stage: projection of papilla only, related to recession of areola. Pubic hair stages: 1-prepubertal (can see velus hair similar to abdominal wall); 2-sparse growth of long, slightly pigmented hair, straight or curled, mainly on labia; 3-Darker, coarser and more curled hair, spreading sparsely over junction of pubes; 4-hair adult in type, but covering smaller area than in adult; no spread to medial surface of thighs; 5-adult in type and quantity, with horizontal distribution.
At Weeks 96, 144, 192, 240, 288 and 336

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スポンサー

Biogen

捜査官

  • スタディディレクター：Medical Director、Biogen

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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 (実際)

2014年8月28日

一次修了 (実際)

2025年7月8日

研究の完了 (実際)

2025年7月8日

試験登録日

最初に提出

2014年11月3日

QC基準を満たした最初の提出物

2014年11月4日

最初の投稿 (推定)

2014年11月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月19日

QC基準を満たした最後の更新が送信されました

2026年5月16日

最終確認日

2026年5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

  • 109MS306
  • 2013-002318-11 (EudraCT番号)

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