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OpenTrials
Completed

NCT Number: NCT00557011

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

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.

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NRP104

Drug

30 mg, 50 mg or 70 mg capsules taken orally once daily in the morning

Other names: lisdexamfetamine dimesylate

Adderall XR

Drug

10 mg capsules taken once daily in the morning at dosages of either 1x10mg, 2x10mg or 3x10mg

Other names: mixed salts of a single-entity amphetamine

Placebo

Drug

Placebo capsule taken once daily in the morning

Primary outcomes

  1. SKAMP-DS scores across a treatment assessment day

    Time frame: 1 week

Secondary outcomes

  1. SKAMP Attention Scale, PERMP attempted score, PERMP correct score, and CGI scores across the treatment assessment day

    Time frame: 1 week

  2. Treatment emergent adverse events

    Time frame: 1 week

  3. PK profile and PK/PD relationship of NRP104

    Time frame: After multiple doses

Sponsors and collaborators

Lead sponsor

New River Pharmaceuticals

Industry

Registry information

Official study 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)

Important dates

Study start
2004
Study completion
2004
First posted
Nov 12, 2007
Registry last updated
May 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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