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

Attention Deficit Hyperactivity Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00556296
• Other study ID #: NRP104.301
• Status: Completed
• Phase: Phase 3
• First received: November 7, 2007
• Last updated: June 20, 2011
• Start date: October 2004
• Est. completion date: September 2005

Study information

• Verified date: June 2011
• Source: New River Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 297
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• NRP104
NRP104 30mg capsule once daily in a.m.
• NRP104
NRP104 50mg capsule once daily in a.m.
• NRp104
NRP104 70mg capsule once daily in a.m.
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
New River Pharmaceuticals	Shire

References & Publications (2)

Biederman J, Krishnan S, Zhang Y, McGough JJ, Findling RL. Efficacy and tolerability of lisdexamfetamine dimesylate (NRP-104) in children with attention-deficit/hyperactivity disorder: a phase III, multicenter, randomized, double-blind, forced-dose, paral — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change score from baseline of the ADHD-RS		4 weeks
Secondary	Duration of therapeutic responses using the CPRS ADHD Index		At treatment endpoint, separately for morning, afternoon and evening responses
Secondary	Clinical global impression of severity(CGI-S) and improvement (CGI-I)		Treatment endpoint
Secondary	Treatment emergent AEs		4 weeks

External Links

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