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.

Novartis

Status and phase: Completed; Phase 4

Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)

Treatments: Drug: Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00776009

CRIT124EUS21

Details and patient eligibility

About

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.

Enrollment: 165 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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165 participants in 3 patient groups, including a placebo group

Dex-Methylphenidate hydrochloride (Focalin® XR) 30 mg

Experimental group

Description:

Dex-Methylphenidate hydrochloride (Focalin® XR) 30 mg dose (one 20 mg capsule and one 10 mg capsule) orally once a day for 7 days.

Treatment:

Drug: Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR)

Dex-Methylphenidate hydrochloride (Focalin® XR) 20 mg

Active Comparator group

Description:

Dex-Methylphenidate hydrochloride (Focalin® XR) one 20 mg capsule orally once a day for 7 days.

Treatment:

Drug: Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR)

Placebo

Placebo Comparator group

Description:

Two Capsules taken orally once a day for 7 days

Treatment:

Drug: Placebo