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Trial record 24 of 140 for:    ADHD | Open Studies | United States | Child, Adult

PK/PD Pediatric ADHD Classroom Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Massachusetts General Hospital
Sponsor:
Collaborators:
Food and Drug Administration (FDA)
Center for Psychiatry And Behavioral Medicine Inc.
Information provided by (Responsible Party):
Thomas J. Spencer, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02536105
First received: August 24, 2015
Last updated: July 22, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention
Attention Deficit Hyperactivity Disorder
Drug: Methylphenidate HCl ER tablets 1
Drug: Placebo
Drug: Methylphenidate HCl ER tablets 2
Drug: Methylphenidate HCl ER for suspension

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Pharmacodynamic Studies of Methylphenidate Extended Release Products in Pediatric Attention Deficit Hyperactivity Disorder

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Permanent Product Measure of Performance (PERMP) for three methylphenidate hydrochloride extended-release drug products [ Time Frame: 0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose on each classroom day ] [ Designated as safety issue: No ]
    The 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.

  • Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale for three methylphenidate hydrochloride extended-release drug products [ Time Frame: 0.5, 1.5, 2.5, 4, 5, 6, 8, 10 and 12 hours post-dose on each classroom day ] [ Designated as safety issue: No ]
    The SKAMP scale is a validated, 13-item rating of subjective impairment of classroom behaviors. 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.

  • Maximum drug concentration observed (Cmax) for three methylphenidate hydrochloride extended-release drug products [ Time Frame: 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose on each classroom day ] [ Designated as safety issue: Yes ]
    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

  • Time to reach Cmax (Tmax) for three methylphenidate hydrochloride extended-release drug products [ Time Frame: 0.5, 1.5, 2.5, 4, 5, 6, 8, and 12 hours post-dose on each classroom day ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 150
Study Start Date: May 2016
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
Drug: Methylphenidate HCl ER tablets 1
Placebo Comparator: 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.
Drug: Placebo
Active Comparator: 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
Drug: Methylphenidate HCl ER tablets 2
Active Comparator: 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
Drug: Methylphenidate HCl ER for suspension

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02536105

Contacts
Contact: Sarah Kassabian 617-726-0481 skassabian@mgh.harvard.edu
Contact: Jennifer Wicks 617-726-2697 jwicks@mgh.harvard.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Sarah Kassabian    617-726-0481    skassabian@mgh.harvard.edu   
Contact: Jennifer Wicks    617-726-2697    jwicks@mgh.harvard.edu   
Principal Investigator: Thomas Spencer, MD         
United States, Nevada
Center for Psychiatry and Behavioral Medicine Recruiting
Las Vegas, Nevada, United States, 89128
Contact: Ann Childress, MD    702-545-6404    DrAnn87@aol.com   
Contact: Jayne Schneider, Ph.D.    702-545-6404    JayneSchneiderPhD@gmail.com   
Principal Investigator: Ann Childress, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Food and Drug Administration (FDA)
Center for Psychiatry And Behavioral Medicine Inc.
Investigators
Principal Investigator: Thomas Spencer, MD Massachusetts General Hospital
  More Information

Responsible Party: Thomas J. Spencer, MD, Associate Chief, Clinical and Research Program, Pediatric Psychopharmacology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02536105     History of Changes
Other Study ID Numbers: 2015P001113 
Study First Received: August 24, 2015
Last Updated: July 22, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Attention Deficit Hyperactivity Disorder
ADHD

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 27, 2016