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

June 20, 2011 updated by: New River Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

297

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Drug: NRP104
NRP104 30mg capsule once daily in a.m.
Drug: NRP104
NRP104 50mg capsule once daily in a.m.
EXPERIMENTAL: 2
Drug: NRP104
NRP104 30mg capsule once daily in a.m.
Drug: NRP104
NRP104 50mg capsule once daily in a.m.
EXPERIMENTAL: 3
Drug: NRp104
NRP104 70mg capsule once daily in a.m.
PLACEBO_COMPARATOR: 4
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change score from baseline of the ADHD-RS
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of therapeutic responses using the CPRS ADHD Index
Time Frame: At treatment endpoint, separately for morning, afternoon and evening responses
At treatment endpoint, separately for morning, afternoon and evening responses
Clinical global impression of severity(CGI-S) and improvement (CGI-I)
Time Frame: Treatment endpoint
Treatment endpoint
Treatment emergent AEs
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New River Pharmaceuticals

Collaborators

Shire

Investigators

  • Study Director: Suma Krishnan, New River Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Completion (ACTUAL)

September 1, 2005

Study Registration Dates

First Submitted

November 7, 2007

First Submitted That Met QC Criteria

November 7, 2007

First Posted (ESTIMATE)

November 9, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

June 21, 2011

Last Update Submitted That Met QC Criteria

June 20, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRP104.301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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