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PK/PD Pediatric ADHD Classroom Study

2019年11月23日 更新者：Thomas J. Spencer, MD、Massachusetts General Hospital

Pharmacokinetic Pharmacodynamic Studies of Methylphenidate Extended Release Products in Pediatric Attention Deficit Hyperactivity Disorder

The purpose of this study is to evaluate the association between blood drug levels and the corresponding scores of commonly used behavioral instruments based upon data collected following administration of three different methylphenidate hydrochloride extended-release drug products in children with ADHD.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

This is a randomized, double-blind, 4-treatment and 4-period crossover study conducted in a school laboratory environment to evaluate the hour-by-hour behavioral instrument scores and hour-by-hour PK of 3 different extended-release MPH formulations as well as placebo in children with ADHD. The complete study consists of three periods: Screening, Dose Titration and Double-Blind Crossover in a Laboratory Classroom.

The double-blind phase will consist of four periods (or four weeks): each week will consist of blinded administration with one of the three active methylphenidate hydrochloride treatments or placebo from Sunday through Saturday. On the last day of each period (Saturday), study participants will be evaluated in a laboratory classroom setting. On Saturdays, the blinded doses of each study drug will be administered at the school site by study staff on the morning of the test laboratory classroom day. On the other days, the medication will be taken in the morning at home.

研究の種類

介入

入学 (実際)

88

段階

  • 適用できない

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、02114
        • Massachusetts General Hospital
    • Nevada
      • Las Vegas、Nevada、アメリカ、89128
        • Center for Psychiatry and Behavioral 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

6年～12年 (子)

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:

  1. Male and female outpatients
  2. Ages 6-12 years at time of screening
  3. Judged by the investigator to be physically healthy and suitable for participation in the study
  4. Diagnosis of DSM-5ADHD combined, predominantly inattentive or hyperactive/impulsive presentation, per clinical evaluation and confirmed by the MINI-KID
  5. Clinical Global Impressions-Severity (CGI-S) ≥ 3
  6. ≥ 90th percentile normative value for gender and age on the ADHD RS-IV total score at screening or baseline
  7. Study participant has a parent/legal guardian who is willing and able to give written informed consent for him/her to participate in the study
  8. Study participant must be able to give assent to participate in the trial
  9. Study participant and legal guardian must be able to speak and understand English
  10. Able to tolerate multiple finger pricks
  11. Willing to comply with all study procedures

Exclusion Criteria:

  1. Current (last month) psychiatric diagnosis other than specific phobia, motor skills disorders, oppositional defiant disorder, sleep disorders, elimination disorders, adjustment disorders, learning disorders, or communication disorders. Participants with school phobia or separation anxiety will not be eligible
  2. Cognitively impaired, in the investigator's opinion
  3. Any clinically significant chronic medical condition that, in the judgment of the investigator, may interfere with the participant's ability to participate in the study
  4. Seizure disorder excluding a history of febrile seizures
  5. Thyroid disease
  6. Tourette's disorder or chronic tic disorder (mild medication induced tics are allowed)
  7. Serious cardiac condition including cardiomyopathy, serious arrhythmias, structural cardiac disorders, or severe hypertension
  8. Glaucoma
  9. Current or recent (within the past 6 months) DSM-5 drug dependence or substance abuse (excluding nicotine and caffeine)
  10. Pregnant or nursing females. Females must have a negative urine pregnancy test at screening as well as four additional visits and must be abstinent or use adequate and reliable contraception throughout the study
  11. Currently treated and satisfied with ADHD medication
  12. Current psychotropic medications other than sedative hypnotics for sleep
  13. Use of atomoxetine, clonidine, guanfacine or a monoamine oxidase inhibitor within 28 days of the baseline visit
  14. Participation in another investigational medication study within 30 days prior to screening
  15. Clinically significant abnormal laboratory result, electrocardiogram (ECG) result, physical examination, or vital signs at screening that the investigator considers to be inappropriate to allow participation in the study
  16. Planned use of prohibited drugs from the baseline visit through the end of the trial
  17. History of allergic reaction or a known or suspected sensitivity to any substance that is contained in the study drugs
  18. Food allergies that are determined by the PI as too severe to be easily accommodated for during the study
  19. Inability to swallow study medication

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：クロスオーバー割り当て
  • 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
アクティブコンパレータ：Methylphenidate HCl ER tablets 1
During the open-label optimization phase, one of the methylphenidate hydrochloride extended-release products will be titrated at weekly intervals of 18mg increments until an optimal dose is achieved or a maximum of 72mg per day is reached. During the double-blind phase, participants will receive blinded treatment each week. The dose of each methylphenidate hydrochloride extended-release product will be determined by the optimized dose during the open-label optimization phase
薬：Methylphenidate HCl ER tablets 1
プラセボコンパレーター：Placebo
During the double-blind period, in one of the 4 study weeks, the study participant will take a blinded placebo instead of one of the the 3 active comparators.
薬：プラセボ
アクティブコンパレータ：Methylphenidate HCl ER tablets 2
During the open-label optimization phase, one of the methylphenidate hydrochloride extended-release products will be titrated at weekly intervals of 18mg increments until an optimal dose is achieved or a maximum of 72mg per day is reached. During the double-blind phase, participants will receive blinded treatment each week. The dose of each methylphenidate hydrochloride extended-release product will be determined by the optimized dose during the open-label optimization phase
薬：Methylphenidate HCl ER tablets 2
アクティブコンパレータ：Methylphenidate HCl ER for suspension
During the open-label optimization phase, one of the methylphenidate hydrochloride extended-release products will be titrated at weekly intervals of 18mg increments until an optimal dose is achieved or a maximum of 72mg per day is reached. During the double-blind phase, participants will receive blinded treatment each week. The dose of each methylphenidate hydrochloride extended-release product will be determined by the optimized dose during the open-label optimization phase
薬：Methylphenidate HCl ER for suspension

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
Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products
時間枠：0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose on each classroom day
The Permanent Product Measure of Performance (PERMP) involves objective individualized mathematics tests. Scores will be obtained ten times on each classroom day at pre-dose, and at approximately 0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose. PERMP Attempted is reported here. Scale ranges 0 math questions answered to 400 math questions answered. The more number of questions answered (better score), the higher the PERMP Attempted score is.
0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose on each classroom day
Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for Three Methylphenidate Hydrochloride Extended-release Drug Products
時間枠：0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose on each classroom day
The Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) scale is a validated, 13-item rating of subjective impairment of classroom behaviors (0 = normal/no impairment; 1 = slight impairment; 2 = mild impairment; 3 = moderate impairment; 4 = severe impairment; 5 = very severe impairment; 6 = maximal impairment). The SKAMP consists of four subscales: SKAMP-Attention, SKAMP-Deportment, SKAMP-Quality of Work, and SKAMP-Compliance, in addition to SKAMP-Total (reported here). SKAMP-Total is a sum of the four sub-scales and has a range of 0-78. The higher the score, the higher the impairment. Scores will be obtained during each classroom cycle during each full laboratory classroom day at pre-dose, and at 0.5, 1.5, 2.5, 4, 5, 6, 8, 10, and 12 hours post-dose. The scores will be based on the child's behavior during 20 minutes of each cycle.
0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose on each classroom day
Maximum Drug Concentration Observed (Cmax) for Three Methylphenidate Hydrochloride Extended-release Drug Products
時間枠：0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose on each classroom day
PK samples will be taken eight times on each classroom day at approximately 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose, and Cmax will be measured. The objectives of this measure is to estimate PK metrics, including Cmax, appropriate for characterizing rate and extent of absorption in each phase of the drug release and the evaluate the disposition and eliminating processes for each medication studied. The minimum value is pg/mL and there is was no maximum defined prior to the interventions.
0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose on each classroom day
Time to Reach Cmax (Tmax) for Three Methylphenidate Hydrochloride Extended-release Drug Products
時間枠：0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose on each classroom day
PK samples will be taken eight times on each classroom day at approximately 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose, and Tmax will be measured
0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose on each classroom day

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

Massachusetts General Hospital

協力者

Food and Drug Administration (FDA)
Center for Psychiatry And Behavioral Medicine Inc.

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)

2016年5月1日

一次修了 (実際)

2018年7月1日

研究の完了 (実際)

2018年7月1日

試験登録日

最初に提出

2015年8月24日

QC基準を満たした最初の提出物

2015年8月26日

最初の投稿 (見積もり)

2015年8月31日

学習記録の更新

投稿された最後の更新 (実際)

2019年12月10日

QC基準を満たした最後の更新が送信されました

2019年11月23日

最終確認日

2019年11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

  • 2015P001113
  • 5U01FD005240 (米国FDA認可/契約)

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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