Not Signed In -
Methylphenidate |
Methylin; Ritalin |
Clinical Trial: Efficacy, Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed with ADHD
This study is no longer recruiting patients.
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Purpose
Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will assess the efficacy, duration of effect, tolerability and safety of 4- and 6- hour wear times of SPD485 in 6-12 year old subjects diagnosed with ADHD.
| Condition | Intervention | Phase |
|---|---|---|
| Attention Deficit Disroder with Hyperactivity | Drug: ''''d, I (threo)-methylphenidate, Methylphenidate Transdermal System | Phase II |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title: A Phase IIB, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Dose-Optimization, 3-Way Cross-Over, Analog Classroom Study to Assess the Efficacy, Duration of Effect, Tolerability and Safety of 4- and 6- Hour Wear Times of Methylphenidate Transdermal System (MTS) in Pediatric Subjects Aged 6-12 with Attention-Deficit/Hyperactivity Disorder (ADHD)
Further Study Details:
Primary Outcomes: SKAMP deportment rating scale
Secondary Outcomes: PERMP age-adjusted math test; Clinician-rated ADHD-RS-IV; CGI-I; Parent Global Assessment; Connors'''' Parent Rating Scale; ADHD Impact Module-Children; SKAMP-total and inattention subscales
Expected Total Enrollment: 128
Secondary Outcomes: PERMP age-adjusted math test; Clinician-rated ADHD-RS-IV; CGI-I; Parent Global Assessment; Connors'''' Parent Rating Scale; ADHD Impact Module-Children; SKAMP-total and inattention subscales
Expected Total Enrollment: 128
Study start: May 2005
Eligibility
Ages Eligible for Study: 6 Years - 12 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Subjects have primary diagnosis of ADHD
- Females of childbearing potential must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test
- Subject has an IQ score of >_ 80
- Subject is able to complete as least the Basic Test of the PERMP assessment
Exclusion Criteria:
- Subject has a comorbid psychiatric diagnosis such as Axis II disorders or severe Axis I disorders
- Subject is taking Strattera(r)
- Subject has a recent history of suspected substance abuse or dependence disorder
More Information
Study ID Numbers: SPD485-304
Last Updated: September 8, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00151970
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 8, 2005
Record first received: September 7, 2005
ClinicalTrials.gov Identifier: NCT00151970
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
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