NCT00151996

Brief Summary

The purpose of this study is to assess the safety and tolerability of administering SPD503 (Guanfacine hydrochloride) with psychostimulants (amphetamine or methylphenidate) for treatment of ADHD in children and adolescents aged 6-17

Trial Health

100
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 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

August 16, 2004

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2004

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

November 26, 2009

Completed
Last Updated

June 10, 2021

Status Verified

May 1, 2021

Enrollment Period

4 months

First QC Date

September 7, 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 the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total 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)

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

    6 weeks

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

    Baseline and 6 weeks

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

    6 weeks

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

    Baseline and 6 weeks

Study Arms (2)

Methylphenidate + SPD503

EXPERIMENTAL
Drug: Methylphenidate + SPD503 (Guanfacine hydrochloride)

Amphetamine + SPD503

EXPERIMENTAL
Drug: Amphetamine + SPD503

Interventions

Methylphenidate + SPD503 (Guanfacine hydrochloride)DRUG
Methylphenidate + SPD503
Amphetamine + SPD503DRUG
Amphetamine + SPD503

Eligibility Criteria

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

You may qualify if:

  • Subjects with a primary diagnosis of ADHD
  • Subject on a stable dose of a psychostimulant approved for the treatment of ADHD for at least 1 month, with sub-optimal control in the Investigator's opinion
  • Male or non-pregnant female subject who agrees to comply with any applicable contraceptive requirements

You may not qualify if:

  • Subject has current uncontrolled comorbid psychiatric diagnosis (except ODD and mild anxiety) with significant symptoms
  • History of seizure during the last 2 years
  • Subject has any specific cardiac condition or family history of significant cardiac condition
  • Subject is pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Spencer TJ, Greenbaum M, Ginsberg LD, Murphy WR. Safety and effectiveness of coadministration of guanfacine extended release and psychostimulants in children and adolescents with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2009 Oct;19(5):501-10. doi: 10.1089/cap.2008.0152.

    PMID: 19877974RESULT

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

MethylphenidateGuanfacineAmphetamine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGuanidinesAmidinesAmphetaminesPhenethylaminesEthylaminesAmines

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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 9, 2005

Study Start

August 16, 2004

Primary Completion

December 27, 2004

Study Completion

December 27, 2004

Last Updated

June 10, 2021

Results First Posted

November 26, 2009

Record last verified: 2021-05