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

This study has been completed.
Sponsor:
Collaborator:
Shire Development LLC
Information provided by:
New River Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00556296
First received: November 7, 2007
Last updated: June 20, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
 Drug: NRP104
Drug: NRp104
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by New River Pharmaceuticals:

Primary Outcome Measures:
  • Change score from baseline of the ADHD-RS [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Duration of therapeutic responses using the CPRS ADHD Index [ Time Frame: 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 emergent AEs [ Time Frame: 4 weeks ]

Enrollment: 297
Study Start Date: October 2004
Study Completion Date: September 2005
Arms Assigned Interventions
Experimental: 1 Drug: NRP104
NRP104 30mg capsule once daily in a.m.
Experimental: 2 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

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00556296

Sponsors and Collaborators
New River Pharmaceuticals
Shire Development LLC
Investigators
Study Director: Suma Krishnan New River Pharmaceuticals
  More Information

Additional Information:
FDA-approved label, US only  This link exits the ClinicalTrials.gov site
FDA Recall Information  This link exits the ClinicalTrials.gov site
FDA Medical Product Safety Alerts  This link exits the ClinicalTrials.gov site

Publications:
Faraone SV, Spencer TJ, Kollins SH and Glatt SJ. Moderators of Dose-Response Effects of Lisdexamfetamine Dimesylate Treatment in Children With ADHD. Journal of ADHD and Related Disorders 1(3):16-24, 2010

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00556296     History of Changes
Other Study ID Numbers: NRP104.301
Study First Received: November 7, 2007
Last Updated: June 20, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
 Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013