Back to resultsQuillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Quillivant Oral Suspension XR
Placebo
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Hyperactivity Attention Deficit Disorder, ADHD, Pediatric Patients, Quillivant, methylphenidate
Eligibility 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.
Sites / Locations
- UC Irvine Child Development Center
- Center for Psychiatry and Behavioral Medicine, Incorporated
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active
Comparator
Arm Description
Outcomes
Primary Outcome Measures
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores at 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 Outcome Measures
Onset and Duration of Clinical Effect Based on SKAMP-Combined Scale
Onset and duration is determined using SKAMP combined rating scale at each post-dose time point. Onset of effect is defined as first assessment time showing statistical significance (i.e. p is less than or equal to [=<] 0.05) between NWP06 and placebo and duration of effect is defined as the as last consecutive time-point at which difference is still statistically significant between NWP06 and placebo. SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is 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 total possible combined score of 0 to 78; where higher score signified worst impairment.
SKAMP Attention Subscale Score Over 12 Hours
SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is 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 total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP attention subscale is reported which evaluates concentration in the classroom and comprises of 4 items, with a total possible score for of 0 to 24; higher score indicates worst impairment.
SKAMP Deportment Subscale Score Over 12 Hours
SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is 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 total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP deportment subscale is reported which assesses behavior in the classroom and comprises of 4 items, with a total possible score for each sub-scale of 0 to 24; higher score indicates worst impairment.
Permanent Product Measure of Performance (PERMP) Score Over 12 Hours
The PERMP is a 10-minute written test, on 80 math problems, performed as seatwork in the classroom. At the end of the 10-minute math test , the PERMP score of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session was used to measure a participant's performance. The total score range from 0-160 with higher scores indicating better performance.
SKAMP Combined Scores Over 12 Hours
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 combined 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00904670
Brief Title
Quillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
Official Title
NWP06 in the Treatment of Children With Attention Deficit Hyperactivity Disorder (ADHD)- A Laboratory Classroom Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Hyperactivity Attention Deficit Disorder, ADHD, Pediatric Patients, Quillivant, methylphenidate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Title
Comparator
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Quillivant Oral Suspension XR
Other Intervention Name(s)
methylphenidate hydrochloride oral suspension
Intervention Description
Oral Suspension 25mg/5mL; 20-60 mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo Oral Suspension 25mg/5mL; 20-60 mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo was a solution that was identical in taste and appearance to the Active drug that was used in this study.
Primary Outcome Measure Information:
Title
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores at Hour 4 Post-Dose
Description
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.
Time Frame
Hour 4 post-dose
Secondary Outcome Measure Information:
Title
Onset and Duration of Clinical Effect Based on SKAMP-Combined Scale
Description
Onset and duration is determined using SKAMP combined rating scale at each post-dose time point. Onset of effect is defined as first assessment time showing statistical significance (i.e. p is less than or equal to [=<] 0.05) between NWP06 and placebo and duration of effect is defined as the as last consecutive time-point at which difference is still statistically significant between NWP06 and placebo. SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is 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 total possible combined score of 0 to 78; where higher score signified worst impairment.
Time Frame
0.75, 2, 8, 10, 12 hours post-dose
Title
SKAMP Attention Subscale Score Over 12 Hours
Description
SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is 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 total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP attention subscale is reported which evaluates concentration in the classroom and comprises of 4 items, with a total possible score for of 0 to 24; higher score indicates worst impairment.
Time Frame
0.75, 2, 4, 8, 10, 12 hours post-dose
Title
SKAMP Deportment Subscale Score Over 12 Hours
Description
SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP combined score is 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 total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP deportment subscale is reported which assesses behavior in the classroom and comprises of 4 items, with a total possible score for each sub-scale of 0 to 24; higher score indicates worst impairment.
Time Frame
0.75, 2, 4, 8, 10, 12 hours post-dose
Title
Permanent Product Measure of Performance (PERMP) Score Over 12 Hours
Description
The PERMP is a 10-minute written test, on 80 math problems, performed as seatwork in the classroom. At the end of the 10-minute math test , the PERMP score of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session was used to measure a participant's performance. The total score range from 0-160 with higher scores indicating better performance.
Time Frame
0.75, 2, 4, 8, 10, 12 hours post-dose
Title
SKAMP Combined Scores Over 12 Hours
Description
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 combined 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.
Time Frame
0.75, 2, 8, 10, 12 hours post-dose
Other Pre-specified Outcome Measures:
Title
SKAMP Quality of Work Subscale Score Over 12 Hours
Description
SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP composite score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP composite score is 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 total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP quality of work subscale is reported which comprises of 3 items, with a total possible score of 0 to 18; higher score indicates worst impairment.
Time Frame
0.75, 2, 4, 8, 10, 12 hours post-dose
Title
SKAMP Compliance Subscale Score Over 12 Hours
Description
SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP composite score is comprised of 13 items [subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)]. SKAMP composite score is 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 total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP compliance subscale is reported which comprises of 2 items, with a total possible score of 0 to 12; higher score indicates worst impairment.
Time Frame
0.75, 2, 4, 8, 10, 12 hours post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
UC Irvine Child Development Center
City
Irvine
State/Province
California
ZIP/Postal Code
92612
Country
United States
Facility Name
Center for Psychiatry and Behavioral Medicine, Incorporated
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23289899
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=NWP06-ADD-100&StudyName=Quillivant%20Oral%20Suspension%20%28Quillivant%20XR%29%20in%20the%20Treatment%20of%20Attention%20Deficit%20Hyperactivity%20Disorder%20%28ADHD%29
Description
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Quillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
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