A Study of Dex-methylphenidate Extended Release in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD)

NCT00564954 | Completed Phase 4 Results

• 1 other identifier: CRIT124EUS19
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 5

Brief Summary

This study compared the efficacy of dex-methylphenidate extended release 20 mg versus placebo during an 8-hour laboratory classroom day.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; children; laboratory classroom; Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• Change From Pre-dose (0 hr [Hour]) on the Swanson, Kotkin, Agler, M-Flynn & Pelham (SKAMP) Rating Scale Combined Score at 0.5 Hour During the 8- Hour Laboratory Classroom Day

  SKAMP rating scale is comprised of 13 questions (7 questions on attention and 6 questions on deportment) evaluating classroom behavior; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78.

  0 hr and 0.5 hr post-dose

Secondary Outcomes (5)

• Change From Pre-dose (0 hr) in SKAMP Combined Score at All Times Excluding the 0.5 Hour Timepoint (Hours 1, 2, 4, 6, 8)

  0, 1, 2, 4, 6, and 8 hr

• Change From Pre-dose in SKAMP Attention Score at All Timepoints (0.5, 1, 2, 4, 6, 8)

  0, 0.5, 1, 2, 4, 6, and 8 hours

• Change From Pre-dose in SKAMP Deportment Score

  0, 0.5, 1, 2, 4, 6 and 8 hours

• Change From Pre-dose (0 hr.) in Permanent Product Measure of Performance (PERMP) Math Test-Attempted Scores at All Timepoints (0.5, 1, 2, 4, 6, 8)

  0, 0.5, 1, 2, 4, 6 and 8 hours

• Change From Pre-dose in Number of Math Questions Answered Correctly on the Permanent Product Measure of Performance (PERMP) Math Test

  0, 0.5, 1, 2, 4, 6 and 8 hours

Study Arms (2)

Dex-methylphenidate hydrochloride (Focalin XR)

EXPERIMENTAL

20 mg capsule orally once a day for 7 days

Drug: Dex-methylphenidate hydrochloride extended-release (Focalin XR)

Placebo

PLACEBO COMPARATOR

orally once a day for 7 days

Drug: Placebo

Interventions

Dex-methylphenidate hydrochloride extended-release (Focalin XR) DRUG

20 mg capsule orally once a day for 7 days

Also known as: Focalin XR

Dex-methylphenidate hydrochloride (Focalin XR)

Placebo DRUG

orally once a day for 7 days

Placebo

Eligibility Criteria

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

You may qualify if:

• Male and female subjects aged 6-12 years, inclusive.
• Subjects meeting the DSM-IV criteria for ADHD of any type, as established by the K-SADS-PL (Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version). If a DSM-IV-defined ADHD diagnosis is difficult to establish due to possible co-morbidity, the subject will not be enrolled into the study.
• Subjects should be on a stabilized total daily dose or nearest equivalent of 40-60 mg methylphenidate or 20-30 mg of d-methylphenidate for at least two weeks prior to screening visit (Concerta® 36 mg and 54 mg is allowable)

You may not qualify if:

• Parent or guardian unable or unwilling to complete the Conner's ADHD/DSM-IV Scale for Parents (CADS-P) and the Daily Diary Card
• Diagnosed with a tic disorder or Tourette's syndrome
• History of seizure disorder
• The presence of a known medical condition that would preclude the use of methylphenidate. A history (within the past year) or presence of clinically significant cardiovascular, cerebrovascular, renal, hepatic, gastrointestinal, pulmonary, immunological, hematological, endocrine, or neurological disease
• ALT, AST, GGPT or serum creatinine greater then 2X the ULN at Screening
• A history of psychiatric illness or substance use disorder (e.g., schizophrenia, bipolar disorder, autism, abuse or dependence, depression, severe Conduct Disorder or severe Oppositional defiant disorder)
• Subjects who have participated in an investigational trial within the past 4 weeks (28 days) are excluded
• Subjects who are currently taking antidepressants or other psychotropic medication
• Subjects who have initiated psychotherapy during the three months prior to randomization
• Subjects with a positive urine drug screen
• Subjects who have a history of poor response or intolerance to methylphenidate or d-methylphenidate

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (5)

Novartis Investigative Site

Little Rock, Arkansas, 72205, United States

Location

Novartis Investigative Site

Winter Park, Florida, 32792, United States

Location

Novartis Investigative Site

Las Vegas, Nevada, 89128, United States

Location

Novartis Investigative Site

Houston, Texas, 77007, United States

Location

Novartis Investigative Site

Lubbock, Texas, 79423, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Dexmethylphenidate Hydrochloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methylphenidate; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2007
• First Posted: November 29, 2007
• Study Start: October 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: April 27, 2012
• Results First Posted: March 30, 2009

Record last verified: 2012-04

Locations

US (5)