Phase 3 Randomized Double-Blind Placebo-Controlled Study of NRP104 in Children Aged 6-12 With ADHD
Phase 3
Completed
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- Drug: Placebo
- Registration Number
- NCT00556296
- Lead Sponsor
- New River Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 297
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4 Placebo - 1 NRp104 - 2 NRp104 - 3 NRp104 -
- Primary Outcome Measures
Name Time Method Change score from baseline of the ADHD-RS 4 weeks
- Secondary Outcome Measures
Name Time Method 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