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

NCT00556296 | Completed Phase 3

• 1 other identifier: NRP104.301
• Study Type: interventional
• Target: 297
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• Change score from baseline of the ADHD-RS

  4 weeks

Secondary Outcomes (3)

• Duration of therapeutic responses using the CPRS ADHD Index

  At treatment endpoint, separately for morning, afternoon and evening responses

• Clinical global impression of severity(CGI-S) and improvement (CGI-I)

  Treatment endpoint

• Treatment emergent AEs

  4 weeks

Study Arms (4)

1

EXPERIMENTAL

Drug: NRP104

2

EXPERIMENTAL

Drug: NRP104

3

EXPERIMENTAL

Drug: NRp104

4

PLACEBO COMPARATOR

Drug: Placebo

Interventions

NRp104 DRUG

NRP104 30mg capsule once daily in a.m.

1

Placebo DRUG

Placebo

4

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New River Pharmaceuticals: lead
• Shire: collaborator

Related Publications (5)

• 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.

  PMID: 17577466 RESULT

• 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

  RESULT

• 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.

  PMID: 22054243 DERIVED

• 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.

  PMID: 21367347 DERIVED

• 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.

  PMID: 20215923 DERIVED

Related Links

• FDA Recall Information

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Suma Krishnan

  New River Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 7, 2007
• First Posted: November 9, 2007
• Study Start: October 1, 2004
• Study Completion: September 1, 2005
• Last Updated: June 21, 2011

Record last verified: 2011-06