NCT00150592

Brief Summary

The purpose of this study is to determine the effects of SPD503 compared to placebo on tasks of sustained attention in children and adolescents aged 6-17 diagnosed with ADHD.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
182

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2005

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

May 12, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2005

Completed
4 years until next milestone

Results Posted

Study results publicly available

October 14, 2009

Completed
Last Updated

June 10, 2021

Status Verified

May 1, 2021

Enrollment Period

5 months

First QC Date

September 6, 2005

Results QC Date

September 10, 2009

Last Update Submit

May 29, 2021

Conditions

Attention Deficit Disorder With Hyperactivity

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Choice Reaction Time (CRT) at 6 Weeks

    Choice reaction time (CRT) is a computerized assessment that trains the subject in holding down a press-pad and releasing the press-pad in response to stimuli presented on the screen. The task requires the subject to react as soon as a yellow dot appears in one of five locations, and the subject must respond by lifting their hand from the press-pad. This is the reaction time (RT) and ranges from 100 to 5000 msec. Lower scores indicate better performance.

    Baseline and 6 weeks

Secondary Outcomes (7)

  • Change From Baseline in Digital Symbol Substitution Task/Coding Test (DSST/Coding) Scores at 6 Weeks in Age Category 8-17 Years

    Baseline and 6 weeks

  • Change From Baseline in DSST/Coding Scores at 6 Weeks in Age Category 6-7 Years

    Baseline and 6 weeks

  • Change From Baseline in Spatial Working Memory (SWM) Scores at 6 Weeks

    Baseline and 6 weeks

  • Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at 6 Weeks

    Baseline and 6 weeks

  • Number of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I) at 6 Weeks

    6 weeks

  • +2 more secondary outcomes

Study Arms (2)

SPD503 (Guanfacine HCl)

EXPERIMENTAL
Drug: SPD503 (Guanfacine HCl)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SPD503 (Guanfacine HCl)DRUG
SPD503 (Guanfacine HCl)
PlaceboDRUG
Placebo

Eligibility Criteria

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

You may qualify if:

  • Subjects with a primary diagnosis of ADHD
  • Minimum baseline visit ADHD-RS-IV score of 24 and a baseline CGI-S score =\>4
  • Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements
  • Subject weighs \> 55 lbs and is not morbidly overweight

You may not qualify if:

  • Subject has a comorbid psychiatric diagnosis (except ODD) with significant symptoms such as any severe comorbid Axis II disorders or severe Axis I disorders
  • Subject has a history of seizure disorder
  • Subject has any specific cardiac condition or family history of significant cardiac condition
  • Subject is pregnant, lactating or within six month post-partum

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kollins SH, Lopez FA, Vince BD, Turnbow JM, Farrand K, Lyne A, Wigal SB, Roth T. Psychomotor functioning and alertness with guanfacine extended release in subjects with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2011 Apr;21(2):111-20. doi: 10.1089/cap.2010.0064. Epub 2011 Apr 10.

    PMID: 21476931RESULT

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Guanfacine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsPhenylacetatesAcids, CarbocyclicCarboxylic Acids

Results Point of Contact

Title
Study Director
Organization
Shire
ClinicalTransparency@shire.com
+1 866 842 5335

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

May 12, 2005

Primary Completion

October 5, 2005

Study Completion

October 5, 2005

Last Updated

June 10, 2021

Results First Posted

October 14, 2009

Record last verified: 2021-05