Attention Deficit Hyperactivity Disorder
Conditions
Brief summary
This study is designed to assess efficacy and safety of NRP-104 administered as a daily dose of 30mg, 50mg or 70mg compared to placebo in the treatment of children aged 6-12 years with ADHD.
Interventions
Sponsors
Shire
New River Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* primary diagnosis of ADHD combined subtype or the predominantly hyperactive-impulsive subtype based on a psychiatric evaluation that reviews DSM-IV criteria * functioning at age appropriate levels intellectually * blood pressure measurements within the 95th percentile for their gender, height and age * ECG results are within the normal range
Exclusion criteria
* comorbid psychiatric diagnosis (such as psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder) or other symptomatic manifestations * history of seizures (exclusive of febrile seizure), a tic disorder, or a family history of Tourette's disorder * weighs less than 55 lbs (25 kg)or is significantly overweight or obese * clinically significant ECG abnormality * documented allergy or intolerance to amphetamines
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change score from baseline of the ADHD-RS | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Duration of therapeutic responses using the CPRS ADHD Index | At treatment endpoint, separately for morning, afternoon and evening responses |
| Clinical global impression of severity(CGI-S) and improvement (CGI-I) | Treatment endpoint |
| Treatment emergent AEs | 4 weeks |
Outcome results
None listed