Efficacy and Safety of Dex-Methylphenidate Extended Release 30 mg Versus 20 mg in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting. - Full Text View

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00776009

Purpose

This study will evaluate the efficacy and safety of Dex-Methylphenidate Extended Release 30 mg compared to 20 mg in pediatric patients ages 6-12 with Attention-Deficit Hyperactivity Disorder (ADHD) in a 12-hour laboratory classroom setting.

Condition	Intervention	Phase
Attention-Deficit/Hyperactivity Disorder (ADHD)	Drug: Dex-Methylphenidate Extended Release Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment
Official Title:	A Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Cross-Over Study Evaluating the Safety and Efficacy of Dex-Methylphenidate Extended Release 30 mg vs. 20 mg as Measured by SKAMP-Combined Scores in Children With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting.

Resource links provided by NLM:

Drug Information available for: Dexmethylphenidate hydrochloride Dexmethylphenidate Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

To evaluate the change in the Swanson, Kotkin, Agler, M Flynn and Pelham (SKAMP) combined, Attention and Deportment scores at 10, 11 and 12 hour time points (post-dose). [ Time Frame: 10, 11 and 12 hour time points (post dose) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the change in the Swanson, Kotkin, Agler, M Flynn and Pelham (SKAMP) combined, Attention and Deportment scores at 3, 6, 9, 10, 11 and 12 hour time points (post-dose). [ Time Frame: 3, 6, 9, 10, 11 and 12 hour time points (post-dose) ] [ Designated as safety issue: No ]
To evaluate the efficacy of Dex-Methylphenidate as measured by the Product Measure of Performance (math test) at hours 3, 6, 9, 10, 11 and 12 post-dose. [ Time Frame: Hours 3, 6, 9, 10, 11 and 12 post-dose ] [ Designated as safety issue: No ]

Enrollment:	165
Study Start Date:	October 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Experimental	Drug: Dex-Methylphenidate Extended Release 30 mg dose
3: Placebo Comparator	Drug: Placebo Placebo Comparator
1: Active Comparator	Drug: Dex-Methylphenidate Extended Release 20 mg dose

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 primary diagnosis of ADHD-Combined type, or predominantly hyperactive-impulsive subtype, 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.

Exclusion Criteria:

Subject or subject's guardian unable to understand or follow instructions necessary to participate in the study.
Diagnosed with or history of 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 (Alanine Amino Transferase), AST (Aspartate Amino Transferase), GGT (Gamma glutamyl transferase) or serum creatinine greater then 2X the ULN (Upper Limit of Normal) 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)
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: NCT00776009

Locations

United States, Arkansas
Clinical Study Center, LLC
Little Rock, Arkansas, United States, 72205
United States, Florida
Florida Clinical Research Center, LLC
Bradenton, Florida, United States, 34208
Miami Research Associates
South Miami, Florida, United States, 33143
United States, Kansas
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66212
United States, Nevada
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, United States, 89128
United States, Texas
Bayou City Research
Houston, Texas, United States, 77007
Behavioral Neurology
Lubbock, Texas, United States, 79423
Claghorn-Lesem Research Clinic
Houston, Texas, United States, 77008

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

Novartis

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CRIT124EUS21
Study First Received:	October 16, 2008
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00776009 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

ADHD, children, subjects, laboratory classroom

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Methylphenidate
Central Nervous System Stimulants
Dyskinesias

Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010