NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

A Phase 2, Randomized, Double-Blind, Placebo- and Active-Controlled, 3-Treatment, 3-Period, Crossover Study With One Week Per Treatment and Once-a-Day Dosing of Either NRP104, Adderall XR, or Placebo in Children Aged 6 to 12 Years With Attention-Deficit Hyperactivity Disorder (ADHD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00557011
• Other study ID #: NRP104.201
• Status: Completed
• Phase: Phase 2
• First received: November 9, 2007
• Last updated: May 23, 2011
• Start date: September 2004
• Est. completion date: December 2004

Study information

• Verified date: May 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

The purpose of this study is to assess, in a controlled environment, the efficacy and safety of NRP104 and Adderall XR compared to placebo in treatment of children, aged 6-12, with ADHD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• males and non-pregnant females, aged 6-12 years DSM-IV-TR criteria for diagnosis of ADHD, combined or hyperactive-impulsive subtypes

• on stable regimen of stimulants for at least one month in the last six months and has shown adequate response to stimulants without unacceptable side effects

Exclusion Criteria:

• co-morbid psychiatric diagnosis such as psychosis, bipolar illness, severe OCD, severe depressive or anxiety disorder

• history of seizure during the last 2 years, a tic disorder or Tourette's

• clinically significant ECG or laboratory abnormalities at screening or baseline

• taking clonidine or anticonvulsant drugs

• taking medications that affect blood pressure or heart rate

Study Design

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

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Drug:
• NRP104
30 mg, 50 mg or 70 mg capsules taken orally once daily in the morning
• Adderall XR
10 mg capsules taken once daily in the morning at dosages of either 1x10mg, 2x10mg or 3x10mg
• Placebo
Placebo capsule taken once daily in the morning

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
New River Pharmaceuticals

References & Publications (1)

Biederman J, Boellner SW, Childress A, Lopez FA, Krishnan S, Zhang Y. Lisdexamfetamine dimesylate and mixed amphetamine salts extended-release in children with ADHD: a double-blind, placebo-controlled, crossover analog classroom study. Biol Psychiatry. 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SKAMP-DS scores across a treatment assessment day		1 week
Secondary	SKAMP Attention Scale, PERMP attempted score, PERMP correct score, and CGI scores across the treatment assessment day		1 week
Secondary	Treatment emergent adverse events		1 week
Secondary	PK profile and PK/PD relationship of NRP104		After multiple doses

External Links

•   FDA Recall information