NCT00150618

Brief Summary

The purpose of this study is to determine the efficacy of SPD503 compared to placebo in the treatment of children and adolescents aged 6-17 with ADHD.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
324

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2004

Shorter than P25 for phase_3

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

March 30, 2004

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2004

Completed
11 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
4.1 years until next milestone

Results Posted

Study results publicly available

October 15, 2009

Completed
Last Updated

June 10, 2021

Status Verified

May 1, 2021

Enrollment Period

6 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 Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Score at 6 Weeks

    Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.

    Baseline and 6 weeks

Secondary Outcomes (4)

  • Change From Baseline in Conner's Parent Rating Scale-revised Short Version (CPRS-R) Score at 6 Weeks

    Baseline and 6 weeks

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

    6 weeks

  • Number of Participants With Improvement in Parent Global Assessment (PGA)

    6 weeks

  • Change From Baseline in Child Health Questionnaire-Parent Form (CHQ-PF50) Score at 6 Weeks

    Baseline and 6 weeks

Study Arms (5)

SPD503 (Guanfacine HCl) (1 mg)

EXPERIMENTAL
Drug: SPD503 (1 mg)

SPD503 (2 mg)

EXPERIMENTAL
Drug: SPD503 (2 mg)

SPD503 (3 mg)

EXPERIMENTAL
Drug: SPD503 (3 mg)

SPD503 (4 mg)

EXPERIMENTAL
Drug: SPD503 (4 mg)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SPD503 (1 mg)DRUG
Also known as: Guanfacine hydrochloride
SPD503 (Guanfacine HCl) (1 mg)
SPD503 (2 mg)DRUG
SPD503 (2 mg)
SPD503 (3 mg)DRUG
SPD503 (3 mg)
SPD503 (4 mg)DRUG
SPD503 (4 mg)
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
  • Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test
  • Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements

You may not qualify if:

  • Subject has a current, uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as severe comorbid Axis II disorders or severe Axis I disorders
  • Subject weighs less than 55 lbs or is morbidly overweight with a BMI =\> 35
  • Subject has a history of seizure during the last 2 years or a serious tic disorder, including Tourette's Disorder
  • Subject is pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sallee FR, McGough J, Wigal T, Donahue J, Lyne A, Biederman J; SPD503 STUDY GROUP. Guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder: a placebo-controlled trial. J Am Acad Child Adolesc Psychiatry. 2009 Feb;48(2):155-65. doi: 10.1097/CHI.0b013e318191769e.

    PMID: 19106767RESULT

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 3
Allocation
RANDOMIZED
Masking
DOUBLE
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

March 30, 2004

Primary Completion

October 7, 2004

Study Completion

October 7, 2004

Last Updated

June 10, 2021

Results First Posted

October 15, 2009

Record last verified: 2021-05