Phase 4
Completed N=86
A Study of Dex-methylphenidate Extended Release in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD)
Source: ClinicalTrials.gov NCT00564954 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Mar 2009
Primary outcomePrimary: Change From Pre-dose (0 hr [Hour]) on the Swanson, Kotkin, Agler, M-Flynn & Pelham (SKAMP) Rating Scale Combined Score at 0.5 Hour During the 8- Hour Laboratory Classroom Day — -0.969; 3.336 score on a scale
Summary
This study compared the efficacy of dex-methylphenidate extended release 20 mg versus placebo during an 8-hour laboratory classroom day.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Pre-dose (0 hr [Hour]) on the Swanson, Kotkin, Agler, M-Flynn & Pelham (SKAMP) Rating Scale Combined Score at 0.5 Hour During the 8- Hour Laboratory Classroom Day |
-0.969; 3.336 | — |
| SECONDARY Change From Pre-dose (0 hr) in SKAMP Combined Score at All Times Excluding the 0.5 Hour Timepoint (Hours 1, 2, 4, 6, 8) |
-6.358; 5.670; -11.573; 5.467; -11.395; 3.925 | — |
| SECONDARY Change From Pre-dose in SKAMP Attention Score at All Timepoints (0.5, 1, 2, 4, 6, 8) |
-0.825; 0.862; -4.208; 2.304; -6.591; 2.465 | — |
| SECONDARY Change From Pre-dose in SKAMP Deportment Score |
0.127; 2.226; -1.863; 3.103; -4.850; 2.881 | — |
| SECONDARY Change From Pre-dose (0 hr.) in Permanent Product Measure of Performance (PERMP) Math Test-Attempted Scores at All Timepoints (0.5, 1, 2, 4, 6, 8) |
6.93; -4.74; 33.26; -12.18; 45.52; -10.19 | — |
| SECONDARY Change From Pre-dose in Number of Math Questions Answered Correctly on the Permanent Product Measure of Performance (PERMP) Math Test |
7.10; -5.96; 31.10; -13.21; 44.92; -11.09 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00564954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.