Quillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)

NCT00904670

Last updated date
Study Location
UC Irvine Child Development Center
Irvine, California, 92612, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Attention Deficit Hyperactivity Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-12 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female from 6 to 12 years of age at the time of screening, inclusive.

- Diagnosis of ADHD by a Psychiatrist, Psychologist, Developmental Pediatrician, or a Pediatrician meeting diagnostic criteria for ADHD (DSM-IV). A Schedule for Affective Disorders and Schizophrenia for School Age Children (K-SADS)16 was administered on all subjects to assist in diagnostic process.

- A clinician-administered Clinical Global Impression of Severity (CGI-S) score of 3 or greater. An Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) score at screening or baseline greater than or equal to the 90th percentile normative values for gender and age in at least one of the following categories: the hyperactive-impulsive subscale, inattentive subscale or the total score.

- Subject must have been in need of pharmacological treatment for ADHD.

- Subjects taking a medication to control ADHD at the time of screening must have been experiencing suboptimal efficacy, a safety or tolerability issue or in need of a long-acting liquid formulation.

- For subjects taking any daily medication at screening aside from ADHD medication: parent or legal guardian agreed that there would be no elective changes in subject's medications during the study (10 weeks total).

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Excluded comorbid psychiatric diagnoses: DSM-IV Axis I diagnosis (active) other than
ADHD, with the exception of Specific Phobias, Learning Disorders, Motor Skills
Disorders, Communication Disorders, Oppositional Defiant Disorder, Elimination
Disorders, Sleep Disorders, and Adjustment Disorders.


- Clinically significant cognitive impairment as assessed in the clinical judgment of
the Investigator. In cases where this was not clear, study staff were permitted to
administer a Wechsler Abbreviated Scale of Intelligence (WASI)17 to estimate the
intelligence quotient (IQ). Significant cognitive impairment for this protocol was
defined as an estimated IQ below 80.


- Subjects with chronic medical illnesses including seizure disorder (excluding a
history of febrile seizures), severe hypertension, thyroid disease, structural cardiac
disorders, serious cardiac conditions, serious arrhythmias, cardiomyopathy, glaucoma,
Tourette's Disorder, family history of Tourette's Disorder or tics.


- Use of monoamine oxidase inhibitors within 30 days of the screening visit.


- Use of any psychotropic medication (except sedative hypnotics prescribed as a sleep
aid at a stable dose for at least 30 days prior to screening, at bedtime only). Use of
stimulant medication for control of ADHD at screening was permitted if inclusion
criterion number 6 was met.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Quillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
Official Title  ICMJE NWP06 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)- A Laboratory Classroom Study
Brief Summary The objective of this study was to establish that an optimal dose of Quillivant XR oral suspension would result in a significant reduction in signs and symptoms of ADHD compared to placebo treatment in pediatric patients ages 6-12 years with ADHD.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Attention Deficit Hyperactivity Disorder
Intervention  ICMJE
  • Drug: Quillivant Oral Suspension XR
    Oral Suspension 25mg/5mL; 20-60 mg/day
    Other Name: methylphenidate hydrochloride oral suspension
  • Drug: Placebo
    Matching Placebo Oral Suspension 25mg/5mL; 20-60 mg/day
  • Drug: Placebo
    Matching placebo was a solution that was identical in taste and appearance to the Active drug that was used in this study.
Study Arms  ICMJE
  • Experimental: Active
    Interventions:
    • Drug: Quillivant Oral Suspension XR
    • Drug: Placebo
  • Placebo Comparator: Comparator
    Intervention: Drug: Placebo
Publications * Wigal SB, Childress AC, Belden HW, Berry SA. NWP06, an extended-release oral suspension of methylphenidate, improved attention-deficit/hyperactivity disorder symptoms compared with placebo in a laboratory classroom study. J Child Adolesc Psychopharmacol. 2013 Feb;23(1):3-10. doi: 10.1089/cap.2012.0073. Epub 2013 Jan 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2009)
45
Original Estimated Enrollment  ICMJE
 (submitted: May 19, 2009)
40
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female from 6 to 12 years of age at the time of screening, inclusive.
  • Diagnosis of ADHD by a Psychiatrist, Psychologist, Developmental Pediatrician, or a Pediatrician meeting diagnostic criteria for ADHD (DSM-IV). A Schedule for Affective Disorders and Schizophrenia for School Age Children (K-SADS)16 was administered on all subjects to assist in diagnostic process.
  • A clinician-administered Clinical Global Impression of Severity (CGI-S) score of 3 or greater. An Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) score at screening or baseline greater than or equal to the 90th percentile normative values for gender and age in at least one of the following categories: the hyperactive-impulsive subscale, inattentive subscale or the total score.
  • Subject must have been in need of pharmacological treatment for ADHD.
  • Subjects taking a medication to control ADHD at the time of screening must have been experiencing suboptimal efficacy, a safety or tolerability issue or in need of a long-acting liquid formulation.
  • For subjects taking any daily medication at screening aside from ADHD medication: parent or legal guardian agreed that there would be no elective changes in subject's medications during the study (10 weeks total).

Exclusion Criteria:

  • Excluded comorbid psychiatric diagnoses: DSM-IV Axis I diagnosis (active) other than ADHD, with the exception of Specific Phobias, Learning Disorders, Motor Skills Disorders, Communication Disorders, Oppositional Defiant Disorder, Elimination Disorders, Sleep Disorders, and Adjustment Disorders.
  • Clinically significant cognitive impairment as assessed in the clinical judgment of the Investigator. In cases where this was not clear, study staff were permitted to administer a Wechsler Abbreviated Scale of Intelligence (WASI)17 to estimate the intelligence quotient (IQ). Significant cognitive impairment for this protocol was defined as an estimated IQ below 80.
  • Subjects with chronic medical illnesses including seizure disorder (excluding a history of febrile seizures), severe hypertension, thyroid disease, structural cardiac disorders, serious cardiac conditions, serious arrhythmias, cardiomyopathy, glaucoma, Tourette's Disorder, family history of Tourette's Disorder or tics.
  • Use of monoamine oxidase inhibitors within 30 days of the screening visit.
  • Use of any psychotropic medication (except sedative hypnotics prescribed as a sleep aid at a stable dose for at least 30 days prior to screening, at bedtime only). Use of stimulant medication for control of ADHD at screening was permitted if inclusion criterion number 6 was met.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00904670
Other Study ID Numbers  ICMJE NWP06-ADD-100
B7491007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP