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

Purpose

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

Condition	Intervention	Phase
Attention Deficit Hyperactivity Disorder	Drug: Dex-methylphenidate hydrochloride extended-release (Focalin XR) Drug: Placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Multi-center, Double-blind, Cross-over Study Comparing the Efficacy and Safety of Focalin® XR 20 mg Versus Placebo at the 0.5 Hour Timepoint (Post-dose) in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate Methylphenidate hydrochloride Dexmethylphenidate hydrochloride

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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 [ Time Frame: 0 hr and 0.5 hr post-dose ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

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) [ Time Frame: 0, 1, 2, 4, 6, and 8 hr ] [ Designated as safety issue: No ]
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.
Change From Pre-dose in SKAMP Attention Score at All Timepoints (0.5, 1, 2, 4, 6, 8) [ Time Frame: 0, 0.5, 1, 2, 4, 6, and 8 hours ] [ Designated as safety issue: No ]
SKAMP attention sub-scale is comprised of 7 questions evaluating concentration in the classroom; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 42.
Change From Pre-dose in SKAMP Deportment Score [ Time Frame: 0, 0.5, 1, 2, 4, 6 and 8 hours ] [ Designated as safety issue: No ]
SKAMP deportment sub-scale is comprised of 6 questions on behavior in the classroom; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 36.
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) [ Time Frame: 0, 0.5, 1, 2, 4, 6 and 8 hours ] [ Designated as safety issue: No ]
Number of math questions attempted within a 10 minute period.
Change From Pre-dose in Number of Math Questions Answered Correctly on the Permanent Product Measure of Performance (PERMP) Math Test [ Time Frame: 0, 0.5, 1, 2, 4, 6 and 8 hours ] [ Designated as safety issue: No ]
Number of math questions answered correctly within a 10 minute period.

Enrollment:	86
Study Start Date:	October 2007
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Dex-methylphenidate hydrochloride (Focalin XR) 20 mg capsule orally once a day for 7 days	Drug: Dex-methylphenidate hydrochloride extended-release (Focalin XR) 20 mg capsule orally once a day for 7 days Other Name: Focalin XR
Placebo Comparator: Placebo orally once a day for 7 days	Drug: Placebo orally once a day for 7 days

Eligibility

Ages Eligible for Study:	6 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Other protocol defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564954

Locations

United States, Arkansas
Novartis Investigative Site
Little Rock, Arkansas, United States, 72205
United States, Florida
Novartis Investigative Site
Winter Park, Florida, United States, 32792
United States, Nevada
Novartis Investigative Site
Las Vegas, Nevada, United States, 89128
United States, Texas
Novartis Investigative Site
Houston, Texas, United States, 77007
Novartis Investigative Site
Lubbock, Texas, United States, 79423

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00564954 History of Changes
Other Study ID Numbers:	CRIT124EUS19
Study First Received:	November 27, 2007
Results First Received:	November 25, 2008
Last Updated:	April 20, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

ADHD
children
laboratory classroom
Attention Deficit Hyperactivity Disorder

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate

Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013