Prader-Willi 症候群 (PWS) の 30 歳までの小児および成人における CBDV とプラセボの比較
2026年4月16日 更新者：Eric Hollander
Prader-Willi症候群（PWS）の30歳までの小児および成人におけるカンナビジバリン（CBDV）とプラセボの比較
この試験は、PWS の子供の治療としてのカンナビジバリン (CBDV) の有効性と安全性を研究することを目的としています。
調査の概要
詳細な説明
この臨床研究試験は、プラダー・ウィリー症候群（PWS）の小児および若年成人におけるフィトカンナビノイドカンナビジオール（CBD）の天然ホモログであるカンナビジバリン（CBDV）の有効性と安全性を研究することを目的としています。
CBDV は、CB1 および CB2 受容体の活性化とは無関係に効果があり、安全性が良好です。
この提案は、プラダー ウィリー リサーチ財団の 5 年間の PWS リサーチ プランに対応しています。プログラム 1、臨床ケア リサーチ: PWS とその家族。
GW ファーマシューティカルズは、CBDV 薬と対応するプラセボ、および追加の資金をサイトに提供します。
研究の種類
介入
入学 (実際)
6
段階
- フェーズ2
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
-
-
New York
-
The Bronx、New York、アメリカ、10467
- Montefiore Medical Center, Albert Einstein College of Medicine
-
-
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
5年～30年 (子、大人)
健康ボランティアの受け入れ
はい
説明
包含基準
- 5歳から30歳までの男性または女性の外来患者。
- 遺伝子検査および患者の医療記録と病歴によって確認された PWS の診断。
- -研究開始前の4週間、および研究期間中の安定した薬理学的、教育的、行動的、および/または食事介入。
- PWSの基準内にある身体検査と検査結果を持っている
- -参加に同意し、研究全体の患者の発達と行動に関する完全な評価を行うことができる親/介護者/保護者の存在。 子供の同意は、対象者が 7 歳以上であり、書面による同意書を理解して署名する、および/または口頭で同意する精神的能力がある場合に取得されます。
- -ベースラインでのClinical Global Impression Scale Severity（CGI-S）≥4（中程度の重症度）のスコア。
- -ベースラインでの異常行動チェックリスト-過敏性（ABC-I）のスコアが18以上。
- 機械を運転したり操作したりしないことに同意します。
除外基準
- -無作為化前の30日間の治験薬への曝露。
- -CBDまたはCBDVによる以前の慢性治療。
- -スクリーニング訪問時の尿検査または繰り返し確認検査時のベースライン訪問によるTHCまたは他の乱用薬物の陽性検査。
- 大麻使用障害を含む薬物乱用障害の病歴
- 双極性障害、精神病、統合失調症、PTSDまたはMDDを含む、PWS以外の主要な精神医学的診断。 これらの患者は、潜在的な交絡結果のために除外されます。
- -被験者の研究への参加能力に深刻な影響を与える、研究の実施を妨害する、研究結果の解釈を混乱させる、または被験者の健康を危険にさらす病状（肝臓または腎臓の障害および心血管疾患を含むがこれらに限定されない）。
- -CBDVまたは製剤に使用される賦形剤に対する既知または疑われるアレルギー（すなわち、 ごま）。
- -BUN /クレアチニンの正常上限を超える値、血清リパーゼおよびアミラーゼ、血小板の正常上限の2倍の値によって証明される、腎、膵臓、または血液機能障害の臨床的徴候
- -ベースラインスクリーニング時のECG異常、またはスクリーニング時の収縮期血圧の臨床的に有意な姿勢低下。 最初のスクリーニング ECG が 460 ミリ秒を超える QTcB を示した場合、5 分間隔で同じ場所に 2 つの追加の ECG が実施されます。 スクリーニングで認識されない場合、すべての包含/除外基準を満たすために、平均QTcBが460ミリ秒以下であることを示す完全な3回繰り返し
- 妊娠中の女性被験者は研究から除外されます。 女性被験者が妊娠できる場合、研究に参加する前に妊娠検査を受けます。 女性被験者は、CBDV を服用している間は妊娠しないように通知されます。 女性被験者は、研究中に妊娠した場合、研究者に伝え、産科医または母体胎児専門医に相談する必要があります。
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：カンナビジバリン (CBDV)
CBDV 10 mg/kg/日の体重ベースの投与量を 12 週間
|
CBDV is obtained from the Cannabis sativa L. plant and contains a negligible quantity (less than 0.2%) of Tetrahydrocannabinol (THC).
|
|
プラセボコンパレーター：一致したプラセボ
プラセボ 10 mg/kg/日の体重ベースの投与を 12 週間
|
プラセボ経口溶液には、対応する賦形剤が含まれています。
|
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 |
|---|---|---|
|
Irritability Based on Aberrant Behavior Checklist-Irritability (ABC-I) Subscale
時間枠：Baseline, Week 4, Week 8, Week 12
|
Irritability will be assessed using the Aberrant Behavior Checklist-Irritability Subscale (ABC-I).
The ABC-I is a well-characterized outcome that is accepted by the FDA for the purpose of labeling and is one of the best and most validated outcome measures in the developmental disabilities.
The ABC-Irritability subscale consists of 15 questions that address the presence of irritability, aggression, tantrums and/or self-injury.
Each item is rated on a scale ranging from 0 ("Not at all a problem") to 3 ("Severe problem"), resulting in a total score range of 0-45, such that higher ABC-I scores are indicative of more severe behavioral problems.
Subjects must score an 18 or higher at screening to be included in the study.
ABC-I scores for Week 4, Week 8, and Week 12 are summarized in the table by study arm using descriptive statistics.
Baseline results for this outcome can be found in the Baseline Characteristics module.
|
Baseline, Week 4, Week 8, Week 12
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Repetitive Behavior Based on the Repetitive Behavior Scale-Revised (RBS-R).
時間枠：Baseline, Week 4, Week 8, Week 12
|
Repetitive behavior will be evaluated using the RBS-R.
RBS-R is a 43-item self-report questionnaire used to measure the breadth or repetitive behaviors in children, adolescents, and adults with ASD.
The RBS-R consists of 6 subscales: Stereotyped Behavior, Self-injurious Behavior, Compulsive Behavior, Ritualistic Behavior, Sameness Behavior, and Restricted Behavior that have no overlap of item content.
Each of the 43 items are rated on a 4-point Likert scale ranging from 0 ("Behavior does not occur") to 3 ("Behavior occurs and is a severe problem"), yielding an overall scoring range of 0-129, such that higher scores are associated with increased severity of the problem behavior.
RBS-R scores for Week 4, Week 8, and Week 12 are summarized in the table by study arm using descriptive statistics.
Baseline results for this outcome can be found in the Baseline Characteristics module.
|
Baseline, Week 4, Week 8, Week 12
|
|
Repetitive Behaviors Based on Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
時間枠：Baseline, Week 4, Week 8, Week 12
|
Obsessive-compulsive symptoms will be assessed using the CY-BOCS.
The CY-BOCS is 10-item clinician-rated measure designed to assess the severity of obsessive-compulsive symptoms in children/adolescents over the prior week.
It consists of 5 primary sections: Time, Distress, Interference, Resistance, and Control of Symptoms.
The 10 items are rated on a scale from 0 ("No symptoms") to 4 ("Extreme symptoms"), for an overall possible range of 0-40, with higher scores indicative of greater severity of symptoms.
CY-BOCS scores for Week 4, Week 8, and Week 12 are summarized by study arm using descriptive statistics.
Baseline results for this outcome can be found in the Baseline Characteristics module.
|
Baseline, Week 4, Week 8, Week 12
|
|
Hyperphagia
時間枠：Baseline, Week 4, Week 8, Week 12
|
Hyperphagia will be assessed using the Hyperphagia Questionnaire for Clinical Trials (HQ-CT).
The HQ-CT is a 9-item caregiver-reported measure of the frequency and intensity of food-seeking behaviors in participants with Prader-Willi Syndrome (PWS) over the prior two-week period.
The 9 items are graded on a Likert scale ranging from 0 ("No Hyperphagia") to 4 ("Most severe hyperphagia"), yielding an overall possible scoring range of 0-36, with higher scores indicating greater, more severe hyperphagia.
HQ-CT scores for Week 4, Week 8, and Week 12 are summarized by study arm using descriptive statistics.
Baseline results for this outcome can be found in the Baseline Characteristics module.
|
Baseline, Week 4, Week 8, Week 12
|
|
Global Functioning
時間枠：Week 4, Week 8, Week 12
|
Global Functioning will be assessed using the Clinical Global Impression Scale - Improvement (CGI-I).
The CGI-I is a global assessment which measures the change in a participant's illness severity, relative to a baseline, considering all symptoms, behaviors, and functional impairment.
It consists of a 7-point clinician-rated scale as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.
such that higher scores are indicative of worsening global function.
CGI-I scores for Week 4, Week 8, and Week 12 are summarized by study arm using basic descriptive statistics.
|
Week 4, Week 8, Week 12
|
|
Caregiver Strain
時間枠：Baseline, Week 4, Week 8, Week 12
|
Caregiver Strain will be evaluated using the Caregiver Strain Questionnaire (CSQ).
The CSQ is a 21-item self-report questionnaire, consisting of 3 subscales, developed to assess caregiver strain/stress for families with a child living with an emotional or behavioral disorder.
Items 1-11 assess Objective Strain.
Items 12, 16-18, and 20-21 assess Subjective Internalized Strain.
Items 13-15, and 19 assess Subjective Externalize Strain.
All CSQ items are rated from 1 ("Not at all a problem") to 5 ("Very much a problem").
Scores are calculated by averaging items within each subscale to handle missing data and calculating a Global Score by summing the 3 subscale means for a total possible scale range of 3-15.
Higher Global Scores are associated with increased Caregiver Strain.
Global results scores for Week 4, Week 8, and Week 12 are summarized by study arm using descriptive statistics.
Baseline results for this outcome can be found in the Baseline Characteristics module.
|
Baseline, Week 4, Week 8, Week 12
|
|
Rigid Behavior - Based on the Montefiore-Einstein Rigidity Scale-Revised-Prader-Willi Syndrome Scale (MERS-R-PWS)
時間枠：Week 12
|
Rigid behavior will be assessed based using the MERS-R-PWS. The MERS-R-PWS is a clinician-rated scale designed to assess 3 domains of rigid behavior in individuals with PWS: Behavioral Rigidity (e.g., Insistence on sameness, things must be done in his/her way, etc.) Cognitive Rigidity (e.g., Special interests, inflexible adherence to rules, etc.) Protest (in response to deviation from rigidity; e.g., tantrum, irritability, arguing) Each domain consists of 4 items rated on a 5-point scale ranging from 0 ("No/None/Not difficult") to 4 ("Extreme/Extremely Difficult"), yielding a range of 0-16. Scores at Week 12 will only be completed for subjects who display rigid behaviors at baseline, week 4, week 8 and week 12. A total MERS-R-PWS score (0-48) is obtained by summing subscale score. Individual subscale scores (0-16) are also summarized. Higher MERS-R-PWS scores are indicative of greater rigidity within each domain and overall rigidity. |
Week 12
|
|
Aberrant Behavior
時間枠：Baseline, Week 4, Week 8, Week 12
|
Aberrant Behavior will be assessed using the Aberrant Behavior Checklist (ABC).
The ABC is a 58-item informative rating instrument used to measure maladaptive behaviors in individuals with developmental disabilities and ASD which resolves into 5 subscales: Irritability (15 items); Lethargy/Social withdrawal (16 items); Stereotypic behavior (7 items); Hyperactivity/noncompliance (16 items); and Inappropriate speech (4 items).
The ABC is completed by a parent/caregiver who knows the participant well.
The ABC measures behavior on a 4-point Likert severity scale: (0 = "Not all a problem," 1 = "Slight problem," 2 = "Moderately serious problem," and 3 = "Severe problem").
Scores for 4 of the 5 subscales are reported below (ABC-I results reported as part of the primary outcome).
Higher ABC subscale scores indicate greater behavioral severity/dysfunction of that subscale.
Week 4, Week 8, and Week 12 scores are summarized by study arm.
See Baseline Characteristics module for baseline data.
|
Baseline, Week 4, Week 8, Week 12
|
|
Sleep Quality
時間枠：Baseline through Week 12
|
Sleep quality will be assessed using ActiGraph GT9X-BT® activity monitors.
Successfully screened patients will receive the actigraphy device prior to the onsite baseline visit and will record a minimum of three days of baseline activity data prior to study initiation.
The ActiGraph GT9X-BT activity monitors are a well validated activity and sleep monitoring device widely utilized in clinical trials and health research.
For this study the ActiGraph monitors will measure: Sleep Latency (the time it takes to fall asleep), Total Sleep Time (the total amount of time spent asleep), and sleep efficiency (percentage of time in bed actually spent sleeping).
Sleep data is captured automatically via cloud service.
All parameters will be reported in hours/minutes and summarized by study arm.
|
Baseline through Week 12
|
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
捜査官
- 主任研究者：Eric Hollander, MD、Montefiore Medical Center/Albert Einstein College of Medicine
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
- Kalsner L, Chamberlain SJ. Prader-Willi, Angelman, and 15q11-q13 Duplication Syndromes. Pediatr Clin North Am. 2015;62(3):587-606.
- Angulo MA, Butler MG, Cataletto ME. Prader-Willi syndrome: a review of clinical, genetic, and endocrine findings. J Endocrinol Invest. 2015;38(12):1249-1263.
- Miller J, Wagner M. Prader-Willi syndrome and sleep-disordered breathing. Pediatr Ann. 2013;42(10):200-204.
- Butler MG, Hossain W, Sulsona C, Driscoll DJ, Manzardo AM. Increased plasma chemokine levels in children with Prader-Willi syndrome. Am J Med Genet A. 2015;167A(3):563-571.
- Viardot A, Sze L, Purtell L, et al. Prader-Willi syndrome is associated with activation of the innate immune system independently of central adiposity and insulin resistance. J Clin Endocrinol Metab. 2010;95(7):3392-3399.
- Irizarry KA, Miller M, Freemark M, Haqq AM. Prader Willi Syndrome: Genetics, Metabolomics, Hormonal Function, and New Approaches to Therapy. Adv Pediatr. 2016;63(1):47-77.
- Rout U, Abdul-Rahman OA, Dhossche DM. An immunological basis of hyperphagia driven by GABAergic dysfunction in Prader-Willi Syndrome. Med Hypotheses. 2012;78(4):462-464.
- Knuesel I, Chicha L, Britschgi M, et al. Maternal immune activation and abnormal brain development across CNS disorders. Nat Rev Neurol. 2014;10(11):643-660.
- Blackmon K. Structural MRI biomarkers of shared pathogenesis in autism spectrum disorder and epilepsy. Epilepsy Behav. 2015;47:172-182.
- Washington J, 3rd, Kumar U, Medel-Matus JS, Shin D, Sankar R, Mazarati A. Cytokinedependent bidirectional connection between impaired social behavior and susceptibility to seizures associated with maternal immune activation in mice. Epilepsy Behav. 2015;50:40- 45.
- Basavarajappa BS, Nixon RA, Arancio O. Endocannabinoid system: emerging role from neurodevelopment to neurodegeneration. Mini Rev Med Chem. 2009;9(4):448-462.
- Kerr DM, Downey L, Conboy M, Finn DP, Roche M. Alterations in the endocannabinoid system in the rat valproic acid model of autism. Behav Brain Res. 2013;249:124-132.
- Klein TW, Cabral GA. Cannabinoid-induced immune suppression and modulation of antigen-presenting cells. J Neuroimmune Pharmacol. 2006;1(1):50-64.
- Devinsky O, Cilio MR, Cross H, et al. Cannabidiol: pharmacology and potential therapeutic role in epilepsy and other neuropsychiatric disorders. Epilepsia. 2014;55(6):791-802.
- Siniscalco D, Bradstreet JJ, Cirillo A, Antonucci N. The in vitro GcMAF effects on endocannabinoid system transcriptionomics, receptor formation, and cell activity of autism-derived macrophages. J Neuroinflammation. 2014;11:78.
- Jean-Gilles L, Gran B, Constantinescu CS. Interaction between cytokines, cannabinoids and the nervous system. Immunobiology. 2010;215(8):606-610.
- Anavi-Goffer S, Baillie G, Irving AJ, et al. Modulation of L-alpha-lysophosphatidylinositol/GPR55 mitogen-activated protein kinase (MAPK) signaling by cannabinoids. J Biol Chem. 2012;287(1):91-104.
- Rock EM, Sticht MA, Duncan M, Stott C, Parker LA. Evaluation of the potential of the phytocannabinoids, cannabidivarin (CBDV) and Delta(9) -tetrahydrocannabivarin (THCV), to produce CB1 receptor inverse agonism symptoms of nausea in rats. Br J Pharmacol. 2013;170(3):671-678.
- Pagano E, Romano B, Iannotti FA, et al. The non-euphoric phytocannabinoid cannabidivarin counteracts intestinal inflammation in mice and cytokine expression in biopsies from UC pediatric patients. Pharmacol Res. 2019;149:104464.
- De Petrocellis L, Ligresti A, Moriello AS, et al. Effects of cannabinoids and cannabinoidenriched Cannabis extracts on TRP channels and endocannabinoid metabolic enzymes. Br J Pharmacol. 2011;163(7):1479-1494.
- Deiana S, Watanabe A, Yamasaki Y, et al. Plasma and brain pharmacokinetic profile of cannabidiol (CBD), cannabidivarine (CBDV), Delta(9)-tetrahydrocannabivarin (THCV) and cannabigerol (CBG) in rats and mice following oral and intraperitoneal administration and CBD action on obsessive-compulsive behaviour. Psychopharmacology (Berl). 2012;219(3):859-873.
- Olah A, Markovics A, Szabo-Papp J, et al. Differential effectiveness of selected nonpsychotropic phytocannabinoids on human sebocyte functions implicates their introduction in dry/seborrhoeic skin and acne treatment. Exp Dermatol. 2016;25(9):701-707.
- Coiro P, Padmashri R, Suresh A, et al. Impaired synaptic development in a maternal immune activation mouse model of neurodevelopmental disorders. Brain Behav Immun. 2015;50:249-258.
- Uzunova G, Pallanti S, Hollander E. Excitatory/inhibitory imbalance in autism spectrum disorders: Implications for interventions and therapeutics. World J Biol Psychiatry. 2016;17(3):174-186.
- Hill AJ, Mercier MS, Hill TD, et al. Cannabidivarin is anticonvulsant in mouse and rat. Br J Pharmacol. 2012;167(8):1629-1642.
- Hill TD, Cascio MG, Romano B, et al. Cannabidivarin-rich cannabis extracts are anticonvulsant in mouse and rat via a CB1 receptor-independent mechanism. Br J Pharmacol. 2013;170(3):679-692.
- Burstein S. Cannabidiol (CBD) and its analogs: a review of their effects on inflammation. Bioorg Med Chem. 2015;23(7):1377-1385.
- Murillo-Rodriguez E, Sarro-Ramirez A, Sanchez D, et al. Potential effects of cannabidiol as a wake-promoting agent. Curr Neuropharmacol. 2014;12(3):269-272.
- Scopinho AA, Guimaraes FS, Correa FM, Resstel LB. Cannabidiol inhibits the hyperphagia induced by cannabinoid-1 or serotonin-1A receptor agonists. Pharmacol Biochem Behav. 2011;98(2):268-272.
- Kuo HY, Liu FC. Molecular Pathology and Pharmacological Treatment of Autism Spectrum Disorder-Like Phenotypes Using Rodent Models. Front Cell Neurosci. 2018;12:422.
- McCracken JT, McGough J, Shah B, et al. Risperidone in children with autism and serious behavioral problems. N Engl J Med. 2002;347(5):314-321.
- Marcus RN, Owen R, Kamen L, et al. A placebo-controlled, fixed-dose study of aripiprazole in children and adolescents with irritability associated with autistic disorder. J Am Acad Child Adolesc Psychiatry. 2009;48(11):1110-1119.
- Lam KS, Aman MG. The Repetitive Behavior Scale-Revised: independent validation in individuals with autism spectrum disorders. J Autism Dev Disord. 2007;37(5):855-866.
- Schertz HH, Odom SL, Baggett KM, Sideris JH. Parent-Reported Repetitive Behavior in Toddlers on the Autism Spectrum. J Autism Dev Disord. 2016;46(10):3308-3316.
- Ventola PE, Yang D, Abdullahi SM, Paisley CA, Braconnier ML, Sukhodolsky DG. Brief Report: Reduced Restricted and Repetitive Behaviors after Pivotal Response Treatment. J Autism Dev Disord. 2016;46(8):2813-2820.
- Goodman WK, Price LH, Rasmussen SA, et al. The Yale-Brown Obsessive Compulsive Scale. I. Development, use, and reliability. Arch Gen Psychiatry. 1989;46(11):1006-1011.
- McCandless SE, Yanovski JA, Miller J, et al. Effects of MetAP2 inhibition on hyperphagia and body weight in Prader-Willi syndrome: A randomized, double-blind, placebocontrolled trial. Diabetes Obes Metab. 2017;19(12):1751-1761.
- Arora T, Broglia E, Pushpakumar D, Lodhi T, Taheri S. An investigation into the strength of the association and agreement levels between subjective and objective sleep duration in adolescents. PLoS One. 2013;8(8):e72406.
- Baum KT, Shear PK, Howe SR, Bishop SL. A comparison of WISC-IV and SB-5 intelligence scores in adolescents with autism spectrum disorder. Autism. 2015;19(6):736745.
- Roid GB, R. . Essentials of Stanford-Binet Intelligence Scales (SB5) Assessment. Hoboken, New Jersey: John Wiley & Sons, Inc; 2004.
- Luther K, Fung GM, Khorassani F. Cost Comparison of Atypical Antipsychotics: Paliperidone ER and Risperidone. Hosp Pharm. 2019;54(6):389-392.
- Al Saabi A, Allorge D, Sauvage FL, et al. Involvement of UDP-glucuronosyltransferases UGT1A9 and UGT2B7 in ethanol glucuronidation, and interactions with common drugs of abuse. Drug Metab Dispos. 2013;41(3):568-574.
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)
2020年11月23日
一次修了 (実際)
2024年10月31日
研究の完了 (実際)
2024年10月31日
試験登録日
最初に提出
2019年2月19日
QC基準を満たした最初の提出物
2019年2月19日
最初の投稿 (実際)
2019年2月20日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月7日
QC基準を満たした最後の更新が送信されました
2026年4月16日
最終確認日
2026年4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
- 2019-9914
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
公開結果の根底にあるすべての IPD
IPD 共有時間枠
Following publication for an indefinite period.
IPD 共有アクセス基準
Contact Principal Investigator for availability of IPD data.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
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。