NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD

New River Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Drug: Placebo; Drug: NRP104; Drug: Adderall XR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00557011

NRP104.201

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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52 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

NRP104

Treatment:

Drug: NRP104

2

Active Comparator group

Description:

Adderall XR

Treatment:

Drug: Adderall XR

3

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo