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.

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00776009

Enrollment

165

Registered

2008-10-20

Start date

2008-10-31

Completion date

2008-12-31

Last updated

2011-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD)

Keywords

ADHD, children, subjects, laboratory classroom

Brief 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.

Interventions

DRUGDex-Methylphenidate hydrochloride Extended Release (Focalin® XR)

10 mg and/or 20 mg capsules

DRUGPlacebo

Placebo Comparator

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 12 Years

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/

Design outcomes

Primary

Measure	Time frame	Description
Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Combined Attention and Deportment Scores at 10, 11, and 12 Hour (Averaged) Post-dose	Pre-dose to 10, 11, and 12 hours post-dose	SKAMP is a 13-item rating scale that measures classroom manifestations of ADHD consisting of 2 subscales (7 items for Attention and 6 items for Deportment) used to generate a score at Hours 10, 11 and 12 on Day 7 of Weeks 1, 2 and 3. The ratings were based on both frequency and quality of specific behaviors. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78. The reported measure is the difference from baseline of the 2 combined subscores averaged over Hours 10, 11 and 12. A negative score indicates improvement.

Secondary

Measure	Time frame	Description
Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Attention Score at 10, 11, and 12 Hour (Averaged) Post-dose	Pre-dose to 10, 11, and 12 hours post-dose	SKAMP is a 13-item rating scale consisting of 2 subscales (7-items for Attention and 6-items for Deportment) that measures classroom manifestations of ADHD. SKAMP was used to generate a score on the Attention subscale at Hours 10, 11, and 12 on Day 7 of Weeks 1, 2, and 3. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 42 for the Attention subscale. The reported measure is the difference from baseline of the subscore averaged over Hours 10, 11, and 12. A negative score indicates improvement.
Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Deportment Score at 10, 11, and 12 Hour (Averaged) Post-dose	Pre-dose to 10, 11, and 12 hours post-dose	SKAMP is a 13-item rating scale consisting of 2 subscales (7-items for Attention and 6-items for Deportment) that measures classroom manifestations of ADHD. SKAMP was used to generate a score on the Deportment subscale at Hours 10, 11, and 12 on Day 7 of Weeks 1, 2, and 3. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 36 for the Deportment subscale. The reported measure is the difference from baseline of the subscore averaged over Hours 10, 11, and 12. A negative score indicates improvement.
Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Attempted Score at 10, 11, and 12 Hours (Averaged) Post-dose	Pre-dose to 10, 11, and 12 hours post-dose	Permanent Product Measure of Performance of Measurement (PERMP) is an age-adjusted, paper-and-pencil math test consisting of 5 pages of 80 math problems each presented in ascending order of difficulty (requiring addition, subtraction, multiplication, and division computations, respectively) during a 10-minute time period. At the end of the 10-minute math test, papers are collected and scored; the number of problems attempted and the number of problems correctly answered are generated as objective measures related to academic productivity. A positive score indicates improvement.
Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Correctly Answered Score at 10, 11, and 12 Hours (Averaged) Post-dose	Pre-dose to 10, 11, and 12 hours post-dose	Permanent Product Measure of Performance of Measurement (PERMP) is an age-adjusted, paper-and-pencil math test consisting of 5 pages of 80 math problems each presented in ascending order of difficulty (requiring addition, subtraction, multiplication, and division computations, respectively) during a 10-minute time period. At the end of the 10-minute math test, papers are collected and scored; the number of problems attempted and the number of problems correctly answered are generated as objective measures related to academic productivity. A positive score indicates improvement.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Focalin XR 20 mg First, Then Focalin XR 30 mg, Then Placebo Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days.	26
Focalin XR 30 mg First, Then Placebo, Then Focalin XR 20 mg Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.	28
Focalin XR 30 mg First, Then Focalin XR 20 mg, Then Placebo Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days .	29
Placebo First, Then Focalin XR 20 mg, Then Focalin XR 30 mg Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.	27
Focalin XR 20 mg First, Then Placebo, Then Focalin XR 30 mg Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.	28
Placebo First, Then Focalin XR 30 mg, Then Focalin XR 20 mg Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.	27
Total	165

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG004	FG005
Period 1: First Intervention	Protocol Violation	0	1	0	1	0
Period 1: First Intervention	Withdrawal by Subject	0	0	1	1	0
Period 2: Second Intervention	Protocol Violation	1	0	1	0	0
Period 2: Second Intervention	Withdrawal by Subject	0	0	0	0	1
Period 3: Third Intervention	Withdrawal by Subject	1	0	0	0	0

Baseline characteristics

Characteristic	Focalin XR 20 mg First, Then Focalin XR 30 mg, Then Placebo	Focalin XR 30 mg First, Then Placebo, Then Focalin XR 20 mg	Focalin XR 30 mg First, Then Focalin XR 20 mg, Then Placebo	Placebo First, Then Focalin XR 20 mg, Then Focalin XR 30 mg	Focalin XR 20 mg First, Then Placebo, Then Focalin XR 30 mg	Placebo First, Then Focalin XR 30 mg, Then Focalin XR 20 mg	Total
Age Continuous	9.3 Years STANDARD_DEVIATION 1.7	9.4 Years STANDARD_DEVIATION 1.7	10.0 Years STANDARD_DEVIATION 1.8	9.4 Years STANDARD_DEVIATION 2	9.5 Years STANDARD_DEVIATION 1.8	9.6 Years STANDARD_DEVIATION 2	9.6 Years STANDARD_DEVIATION 1.8
Region of Enrollment United States	26 participants	28 participants	29 participants	27 participants	28 participants	27 participants	165 participants
Sex: Female, Male Female	9 Participants	16 Participants	10 Participants	10 Participants	12 Participants	14 Participants	71 Participants
Sex: Female, Male Male	17 Participants	12 Participants	19 Participants	17 Participants	16 Participants	13 Participants	94 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	10 / 165	8 / 165	0 / 165
serious Total, serious adverse events	0 / 165	1 / 165	0 / 165

Outcome results

Primary

Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Combined Attention and Deportment Scores at 10, 11, and 12 Hour (Averaged) Post-dose

SKAMP is a 13-item rating scale that measures classroom manifestations of ADHD consisting of 2 subscales (7 items for Attention and 6 items for Deportment) used to generate a score at Hours 10, 11 and 12 on Day 7 of Weeks 1, 2 and 3. The ratings were based on both frequency and quality of specific behaviors. The rating scale is 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78. The reported measure is the difference from baseline of the 2 combined subscores averaged over Hours 10, 11 and 12. A negative score indicates improvement.