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OpenTrials
Completed

NCT Number: NCT00556296

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

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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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NRP104

Drug

NRP104 30mg capsule once daily in a.m.

Placebo

Drug

Placebo

Primary outcomes

  1. Change score from baseline of the ADHD-RS

    Time frame: 4 weeks

Secondary outcomes

  1. Duration of therapeutic responses using the CPRS ADHD Index

    Time frame: At treatment endpoint, separately for morning, afternoon and evening responses

  2. Clinical global impression of severity(CGI-S) and improvement (CGI-I)

    Time frame: Treatment endpoint

  3. Treatment emergent AEs

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

New River Pharmaceuticals

Industry

Collaborators

  • Shire

Registry information

Official study title

A Phase 3, Randomized, Multi-Center, Double-Blind, Parallel-Group, Placebo-Controlled Study of NRP104 in Children Aged 6-12 Years With Attention Deficit Hyperactivity Disorder

Important dates

Study start
2004
Study completion
2005
First posted
Nov 9, 2007
Registry last updated
Jun 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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