Attention Deficit Disorder With Hyperactivity
Conditions
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.
Interventions
DRUGNRP104
30 mg, 50 mg or 70 mg capsules taken orally once daily in the morning
DRUGAdderall XR
10 mg capsules taken once daily in the morning at dosages of either 1x10mg, 2x10mg or 3x10mg
DRUGPlacebo
Placebo capsule taken once daily in the morning
Sponsors
New River Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SKAMP-DS scores across a treatment assessment day | 1 week |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed