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.
Information source: Novartis
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Attention-Deficit/Hyperactivity Disorder (ADHD)
Intervention: Dex-Methylphenidate Extended Release (Drug); Dex-Methylphenidate Extended Release (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis
Overall contact:
Novartis Pharmaceuticals, Phone: 862-778-8300
Summary
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.
Clinical Details
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.
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment
Primary outcome: 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).
Secondary outcome: 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).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.
Eligibility
Minimum age: 6 Years.
Maximum age: 12 Years.
Gender(s): Both.
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
Locations and Contacts
Novartis Pharmaceuticals, Phone: 862-778-8300
Clinical Study Center, LLC, Little Rock, Arkansas 72205, United States; Active, not recruiting
Florida Clinical Research Center, LLC, Bradenton, Florida 34208, United States; Active, not recruiting
Miami Research Associates, South Miami, Florida 33143, United States; Active, not recruiting
Vince and Associates Clinical Research, Overland Park, Kansas 66212, United States; Active, not recruiting
Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, Nevada 89128, United States; Active, not recruiting
Bayou City Research, Houston, Texas 77007, United States; Recruiting
Kathy Harpst, Phone: 832-251-7000
Behavioral Neurology, Lubbock, Texas 79423, United States; Active, not recruiting
Claghorn-Lesem Research Clinic, Houston, Texas 77008, United States; Active, not recruiting
Additional Information
Starting date: October 2008
Last updated: October 16, 2008
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