NCT00904670CompletedPhase 3
NWP06 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)- A Laboratory Classroom Study
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores at Hour 4 Post-Dose
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Active
Experimental
Intervention: Quillivant Oral Suspension XR (Drug)
Active
Experimental
Intervention: Placebo (Drug)
Comparator
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores at Hour 4 Post-Dose
Time Frame: Hour 4 post-dose
The SKAMP scale measures the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP composite score was obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment.
Secondary Outcomes
- Onset and Duration of Clinical Effect Based on SKAMP-Combined Scale(0.75, 2, 8, 10, 12 hours post-dose)
- SKAMP Deportment Subscale Score Over 12 Hours(0.75, 2, 4, 8, 10, 12 hours post-dose)
- SKAMP Attention Subscale Score Over 12 Hours(0.75, 2, 4, 8, 10, 12 hours post-dose)
- Permanent Product Measure of Performance (PERMP) Score Over 12 Hours(0.75, 2, 4, 8, 10, 12 hours post-dose)
- SKAMP Combined Scores Over 12 Hours(0.75, 2, 8, 10, 12 hours post-dose)
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Phase 1
Pharmacokinetic Study of Bilastine in Children From 2 to < 12 Years of Age With Either Allergic Rhinoconjunctivitis (AR) or Chronic Urticaria (CU)Allergic RhinoconjunctivitisChronic UrticariaNCT01081574Faes Farma, S.A.36
Completed
Phase 3
Multicenter Study for Pediatric Subjects Evaluating Pharmacokinetics and Safety of EXPARELPostoperative Pain ManagementNCT03682302Pacira Pharmaceuticals, Inc98
Completed
Not Applicable
Determining Optimal Treatment Intensity for Children With Language ImpairmentLanguage ImpairmentNCT04501536University of Texas at Austin59
Completed
Phase 3
A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children With Atopic Dermatitis (TRuE-AD3)Atopic DermatitisNCT04921969Incyte Corporation330
Not yet recruiting
Phase 2
Addressing Treatment NonrespondersLanguage Development DisordersNCT05921227University of Arizona16