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

NCT00904670 | Completed Phase 3 Results

• 2 other identifiers: NWP06-ADD-100B7491007
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Hyperactivity Attention Deficit Disorder; ADHD; Pediatric Patients; Quillivant; methylphenidate

Outcome Measures

Primary Outcomes (1)

• 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.

  Hour 4 post-dose

Secondary Outcomes (5)

• Onset and Duration of Clinical Effect Based on SKAMP-Combined Scale

  0.75, 2, 8, 10, 12 hours post-dose

• SKAMP Attention Subscale Score Over 12 Hours

  0.75, 2, 4, 8, 10, 12 hours post-dose

• SKAMP Deportment 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

Other Outcomes (2)

• SKAMP Quality of Work Subscale Score Over 12 Hours

  0.75, 2, 4, 8, 10, 12 hours post-dose

• SKAMP Compliance Subscale Score Over 12 Hours

  0.75, 2, 4, 8, 10, 12 hours post-dose

Study Arms (2)

Active

EXPERIMENTAL

Drug: Quillivant Oral Suspension XR; Drug: Placebo

Comparator

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Quillivant Oral Suspension XR DRUG

Oral Suspension 25mg/5mL; 20-60 mg/day

Also known as: methylphenidate hydrochloride oral suspension

Active

Placebo DRUG

Matching Placebo Oral Suspension 25mg/5mL; 20-60 mg/day

Active

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

UC Irvine Child Development Center

Irvine, California, 92612, United States

Location

Center for Psychiatry and Behavioral Medicine, Incorporated

Las Vegas, Nevada, 89128, United States

Location

Related Publications (1)

• 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.

  PMID: 23289899 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

Results for primary outcome is presented as absolute values and not as change from pre-dose and the secondary outcomes are presented at each post-dose time-point and not pre-dose, as planned.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2009
• First Posted: May 20, 2009
• Study Start: April 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: June 26, 2014
• Results First Posted: June 26, 2014

Record last verified: 2014-05

Locations

US (2)