Phase 3 Randomized Double-Blind Placebo-Controlled Study of NRP104 in Children Aged 6-12 With ADHD

New River Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Drug: NRP104; Drug: Placebo; Drug: NRp104

Study type: Interventional

Funder types: Industry

Identifiers

NCT00556296

NRP104.301

Details and patient eligibility

About

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.

Enrollment: 297 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

297 participants in 4 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: NRP104

Drug: NRP104

2

Experimental group

Treatment:

Drug: NRP104

Drug: NRP104

3

Experimental group

Treatment:

Drug: NRp104

4

Placebo Comparator group

Treatment:

Drug: Placebo