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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

297 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

NRP104

Intervention Type DRUG

NRP104 30mg capsule once daily in a.m.

2

Group Type EXPERIMENTAL

NRP104

Intervention Type DRUG

NRP104 50mg capsule once daily in a.m.

3

Group Type EXPERIMENTAL

NRp104

Intervention Type DRUG

NRP104 70mg capsule once daily in a.m.

4

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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NRP104

NRP104 30mg capsule once daily in a.m.

Intervention Type DRUG

NRP104

NRP104 50mg capsule once daily in a.m.

Intervention Type DRUG

NRp104

NRP104 70mg capsule once daily in a.m.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No