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PK/PD Pediatric ADHD Classroom Study

23 listopada 2019 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

88

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • Massachusetts
      • Boston, Massachusetts, Stany Zjednoczone, 02114
        • Massachusetts General Hospital
    • Nevada
      • Las Vegas, Nevada, Stany Zjednoczone, 89128
        • Center for Psychiatry and Behavioral Medicine

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

6 lat do 12 lat (Dziecko)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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
Lek: Methylphenidate HCl ER tablets 1
Komparator placebo: 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.
Lek: Placebo
Aktywny komparator: 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
Lek: Methylphenidate HCl ER tablets 2
Aktywny komparator: 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
Lek: Methylphenidate HCl ER for suspension

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Permanent Product Measure of Performance (PERMP) for Three Methylphenidate Hydrochloride Extended-release Drug Products
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Massachusetts General Hospital

Współpracownicy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 maja 2016

Zakończenie podstawowe (Rzeczywisty)

1 lipca 2018

Ukończenie studiów (Rzeczywisty)

1 lipca 2018

Daty rejestracji na studia

Pierwszy przesłany

24 sierpnia 2015

Pierwszy przesłany, który spełnia kryteria kontroli jakości

26 sierpnia 2015

Pierwszy wysłany (Oszacować)

31 sierpnia 2015

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

10 grudnia 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

23 listopada 2019

Ostatnia weryfikacja

1 listopada 2019

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2015P001113
  • 5U01FD005240 (Dotacja/umowa FDA USA)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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