NCT00557011

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2004

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 12, 2007

Completed
Last Updated

May 25, 2011

Status Verified

May 1, 2011

First QC Date

November 9, 2007

Last Update Submit

May 23, 2011

Conditions

Attention Deficit Disorder With Hyperactivity

Outcome Measures

Primary Outcomes (1)

  • SKAMP-DS scores across a treatment assessment day

    1 week

Secondary Outcomes (3)

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

    1 week

  • Treatment emergent adverse events

    1 week

  • PK profile and PK/PD relationship of NRP104

    After multiple doses

Study Arms (3)

1

EXPERIMENTAL

NRP104

Drug: NRP104

2

ACTIVE COMPARATOR

Adderall XR

Drug: Adderall XR

3

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

NRP104DRUG

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

Also known as: lisdexamfetamine dimesylate
1
Adderall XRDRUG

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

Also known as: mixed salts of a single-entity amphetamine
2
PlaceboDRUG

Placebo capsule taken once daily in the morning

3

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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. 2007 Nov 1;62(9):970-6. doi: 10.1016/j.biopsych.2007.04.015. Epub 2007 Jul 12.

    PMID: 17631866RESULT

  • 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: 20215923DERIVED

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Lisdexamfetamine DimesylateSLI381

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DextroamphetamineAmphetamineAmphetaminesPhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Joseph Biederman, M.D.

    Harvard Medical School (HMS and HSDM)

    PRINCIPAL INVESTIGATOR

  • Samuel Boellner, M.D.

    Clinical Study Centers, LLC

    PRINCIPAL INVESTIGATOR

  • Ann Childress, M.D.

    Center for Psychiatry And Behavioral Medicine Inc.

    PRINCIPAL INVESTIGATOR

  • Frank Lopez, M.D.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 9, 2007

First Posted

November 12, 2007

Study Start

September 1, 2004

Study Completion

December 1, 2004

Last Updated

May 25, 2011

Record last verified: 2011-05