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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00904670
First received: May 18, 2009
Last updated: February 25, 2014
Last verified: February 2014

May 18, 2009
February 25, 2014
April 2009
August 2009   (final data collection date for primary outcome measure)
SKAMP-Combined Scores [ Time Frame: Hours ] [ Designated as safety issue: No ]
Change in mean pre-dose SKAMP-Cobined Score to 4-hour post-dose SKAMP-Combined Score
SKAMP [ Time Frame: Weeks 5-6 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00904670 on ClinicalTrials.gov Archive Site
  • SKAMP-Combined Scores [ Time Frame: hours ] [ Designated as safety issue: No ]

    SKAMP-Combined scores at pre-dose and each post-dose (0.75, 2, 4, 8, 10 and 12 hours) time point and each laboratory classroom day (Visits 7 and 8) included:

    • Onset of clinical effect;
    • Duration of clinical effec
  • SKAMP- Attention Scores [ Time Frame: hours ] [ Designated as safety issue: No ]
    pre-dose and each post-dose (0.75, 2, 4, 8, 10 and 12 hours) time point during each test laboratory classroom day (Visits 7 and 8)
  • SKAMP-Deportment Scores [ Time Frame: hours ] [ Designated as safety issue: No ]
    pre-dose and each post-dose (0.75, 2, 4, 8, 10 and 12 hours) time point during each test laboratory classroom day (Visits 7 and 8)
  • SKAMP-Quality of Work Scores [ Time Frame: hours ] [ Designated as safety issue: No ]
    pre-dose and each post-dose (0.75, 2, 4, 8, 10 and 12 hours) time point during each test laboratory classroom day (Visits 7 and 8)
  • SKAMP-Compliance Scores [ Time Frame: hours ] [ Designated as safety issue: No ]
    pre-dose and each post-dose (0.75, 2, 4, 8, 10 and 12 hours) time point during each test laboratory classroom day (Visits 7 and 8)
  • Written math test (PERMP) scores. [ Time Frame: hours ] [ Designated as safety issue: No ]
    pre-dose and each post-dose (0.75, 2, 4, 8, 10 and 12 hours) time point during each test laboratory classroom day (Visits 7 and 8)
PERMP [ Time Frame: Weeks 5-6 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Quillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
NWP06 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)- A Laboratory Classroom Study

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Attention Deficit Hyperactivity Disorder
  • 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.
  • Experimental: Active
    Interventions:
    • Drug: Quillivant Oral Suspension XR
    • Drug: Placebo
  • Placebo Comparator: Comparator
    Intervention: Drug: Placebo
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.
 
Completed
45
August 2009
August 2009   (final data collection date for primary outcome measure)

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.
Both
6 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00904670
NWP06-ADD-100, B7491007
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2014

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