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

Novartis

Status and phase: Completed; Phase 4

Conditions: Attention Deficit Hyperactivity Disorder

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00564954

CRIT124EUS19

Details and patient eligibility

About

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

Enrollment: 86 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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86 participants in 2 patient groups, including a placebo group

Dex-methylphenidate hydrochloride (Focalin XR)

Experimental group

Description:

20 mg capsule orally once a day for 7 days

Treatment:

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

Placebo

Placebo Comparator group

Description:

orally once a day for 7 days

Treatment:

Drug: Placebo