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

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ClinicalTrials.gov Identifier: NCT00556296
Recruitment Status : Completed
First Posted : November 9, 2007
Last Update Posted : June 21, 2011
Information provided by:
New River Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: NRP104 Drug: NRp104 Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 297 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2004
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00556296

Sponsors and Collaborators
New River Pharmaceuticals
Study Director: Suma Krishnan New River Pharmaceuticals

Additional Information:
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

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
First Posted: November 9, 2007    Key Record Dates
Last Update Posted: June 21, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lisdexamfetamine Dimesylate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents