Efficacy and Safety of Dex-Methylphenidate Extended Release 20 mg Versus Placebo in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention Deficit Hyperactivity Disorder
Intervention: Dex-methylphenidate extended release (Drug); Placebo (Other)
Phase: Phase 4
Sponsored by: Novartis
This study will confirm the efficacy of dex-methylphenidate extended release 20 mg versus
placebo during an 8-hour laboratory classroom day.
Official title: A Randomized, Multi-Center, Double-Blind, Cross-Over Study Comparing the Efficacy and Safety of Dex-Methylphenidate Extended Release 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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Change in The Swanson, Kotkin, Agler, M Flynn and Pelham (SKAMP) Combined score from pre-dose (0 Hour) to 0.5, 1, 2, 4, 6 and 8 hours post-dose. The primary analysis time point is 0.5 hour post-dose.
Change from pre-dose in SKAMP Attention score (at all hours post-dose)
Change from pre-dose in SKAMP Deportment score (at all hours post-dose)
Change from pre-dose in Math Test-attempt scores (at all hours post-dose)
Change from pre-dose in Math Test-correct scores (at all hours post-dose)
Minimum age: 6 Years.
Maximum age: 12 Years.
- 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)
- 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
- Subjects with a positive urine drug screen
- Subjects who have a history of poor response or intolerance to methylphenidate or
Other protocol defined inclusion/exclusion criteria may apply
Locations and Contacts
Novartis Investigative Site, Little Rock, Arkansas 72205, United States
Novartis Investigative Site, Winter Park, Florida 32792, United States
Novartis Investigative Site, Las Vegas, Nevada 89128, United States
Novartis Investigative Site, Houston, Texas 77007, United States
Novartis Investigative Site, Lubbock, Texas 79423, United States
Starting date: October 2007
Ending date: November 2007
Last updated: December 18, 2007