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
  Purpose

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.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: Quillivant Oral Suspension XR
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: NWP06 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)- A Laboratory Classroom Study

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Enrollment: 45
Study Start Date: April 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active 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
Placebo Comparator: Comparator Drug: Placebo
Matching placebo was a solution that was identical in taste and appearance to the Active drug that was used in this study.

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00904670

Locations
United States, California
UC Irvine Child Development Center
Irvine, California, United States, 92612
United States, Nevada
Center for Psychiatry and Behavioral Medicine, Incorporated
Las Vegas, Nevada, United States, 89128
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00904670     History of Changes
Other Study ID Numbers: NWP06-ADD-100, B7491007
Study First Received: May 18, 2009
Last Updated: February 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Hyperactivity Attention Deficit Disorder
ADHD
Pediatric Patients
Quillivant
methylphenidate

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014