Clinical trial NCT00556296: Phase 3 Randomized Double-Blind Placebo-Controlled Study of NRP104 in Children Aged 6-12 With ADHD
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: New River Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Shire
First posted: 2007-11-09
Enrollment: 297
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change score from baseline of the ADHD-RS
timeFrame: 4 weeks
Secondary outcomes:
measure: Duration of therapeutic responses using the CPRS ADHD Index
timeFrame: At treatment endpoint, separately for morning, afternoon and evening responses
measure: Clinical global impression of severity(CGI-S) and improvement (CGI-I)
timeFrame: Treatment endpoint
measure: Treatment emergent AEs
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: New River Pharmaceuticals
name: Suma Krishnan
role: STUDY_DIRECTOR
References:
citation: 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, parallel-group study. Clin Ther. 2007 Mar;29(3):450-63. doi: 10.1016/s0149-2918(07)80083-x.
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
citation: Jain R, Babcock T, Burtea T, Dirks B, Adeyi B, Scheckner B, Lasser R. Efficacy of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder previously treated with methylphenidate: a post hoc analysis. Child Adolesc Psychiatry Ment Health. 2011 Nov 4;5(1):35. doi: 10.1186/1753-2000-5-35.
citation: Waxmonsky JG, Waschbusch DA, Glatt SJ, Faraone SV. Prediction of placebo response in 2 clinical trials of lisdexamfetamine dimesylate for the treatment of ADHD. J Clin Psychiatry. 2011 Oct;72(10):1366-75. doi: 10.4088/JCP.10m05979pur.
citation: Faraone SV, Spencer TJ, Kollins SH, Glatt SJ. Effects of lisdexamfetamine dimesylate treatment for ADHD on growth. J Am Acad Child Adolesc Psychiatry. 2010 Jan;49(1):24-32. doi: 10.1097/00004583-201001000-00006.