NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD
Phase 2
Completed
- Conditions
- Attention Deficit Disorder With Hyperactivity
- Interventions
- Registration Number
- NCT00557011
- Lead Sponsor
- New River Pharmaceuticals
- Brief Summary
The purpose of this study is to assess, in a controlled environment, the efficacy and safety of NRP104 and Adderall XR compared to placebo in treatment of children, aged 6-12, with ADHD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
Inclusion Criteria
- males and non-pregnant females, aged 6-12 years DSM-IV-TR criteria for diagnosis of ADHD, combined or hyperactive-impulsive subtypes
- on stable regimen of stimulants for at least one month in the last six months and has shown adequate response to stimulants without unacceptable side effects
Exclusion Criteria
- co-morbid psychiatric diagnosis such as psychosis, bipolar illness, severe OCD, severe depressive or anxiety disorder
- history of seizure during the last 2 years, a tic disorder or Tourette's
- clinically significant ECG or laboratory abnormalities at screening or baseline
- taking clonidine or anticonvulsant drugs
- taking medications that affect blood pressure or heart rate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 NRP104 NRP104 2 Adderall XR Adderall XR 3 Placebo Placebo
- Primary Outcome Measures
Name Time Method SKAMP-DS scores across a treatment assessment day 1 week
- Secondary Outcome Measures
Name Time Method SKAMP Attention Scale, PERMP attempted score, PERMP correct score, and CGI scores across the treatment assessment day 1 week Treatment emergent adverse events 1 week PK profile and PK/PD relationship of NRP104 After multiple doses