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

NCT ID: NCT00904670

Last Updated: 2014-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2009-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active

Group Type: EXPERIMENTAL

Quillivant Oral Suspension XR

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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

Comparator

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo was a solution that was identical in taste and appearance to the Active drug that was used in this study.

Interventions

Quillivant Oral Suspension XR

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Placebo

Matching placebo was a solution that was identical in taste and appearance to the Active drug that was used in this study.

Intervention Type: DRUG

Other Intervention Names

methylphenidate hydrochloride oral suspension

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

UC Irvine Child Development Center

Irvine, California, United States

Center for Psychiatry and Behavioral Medicine, Incorporated

Las Vegas, Nevada, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23289899 (View on PubMed)

Related Links

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

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Other Identifiers

B7491007

Identifier Type: -

Identifier Source: secondary_id

NWP06-ADD-100

Identifier Type: -

Identifier Source: org_study_id