SPD503 (Guanfacine Hydrochloride) in ADHD Plus Oppositional Symptoms

ADHD Clinical Trial

Official title:

A Double-Blind, Randomized, Multi-Center, Flexible Dose Study Evaluating the Efficacy and Safety of SPD503 (Guanfacine Hydrochloride) in Children Aged 6-12 With Symptoms of Oppositionality and a Diagnosis of Attention Deficit/Hyperactivity Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00367835
• Other study ID #: SPD503-307
• Status: Completed
• Phase: Phase 3
• Start date: December 4, 2006
• Est. completion date: January 4, 2008

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess efficacy and safety of SPD503(guanfacine hydrochloride) in subjects with ADHD and oppositional symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: January 4, 2008
• Est. primary completion date: January 4, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Healthy subjects with ADHD and oppositional symptoms
• ADHD-RS>=24
• CGI >=4
• T-score of Opp subscale CPRS-R:L >=65
• Normal ECG and BP
• >= 55 lbs

Related Conditions & MeSH terms

• ADHD

Intervention

Drug:
• SPD503 (Guanfacine hydrochloride)
Subjects will start at 1mg tablet each morning and will subsequently be titrated (in 1 mg weekly increments) to optimal dose based upon tolerance and response to investigational product (not to exceed 4 mg/day).
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Piedmont Neuropsychiatry	Charlotte	North Carolina
United States	University of Cincinnati	Cincinnati	Ohio
United States	CRI Worldwide, LLC	Clementon	New Jersey
United States	Discovery and Wellness Center for Children	Cleveland	Ohio
United States	Duke Child & Family Study Center	Durham	North Carolina
United States	Valley Clinical Research	El Centro	California
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	University of Florida	Gainesville	Florida
United States	NeuroScience, Inc	Herndon	Virginia
United States	Amedica Research Institute, Inc	Hialeah	Florida
United States	Claghorn-Lesem Research Clinic Inc	Houston	Texas
United States	Red Oak Psychiatry Associates, PA	Houston	Texas
United States	Eastside Therapeutic Resource	Kirkland	Washington
United States	Capstone Clinical Research	Libertyville	Illinois
United States	CORE Research, Inc	Maitland	Florida
United States	Miami Research Associates	Miami	Florida
United States	Dominion Clinical Research	Midlothian	Virginia
United States	BHI Inc	Moore	Oklahoma
United States	Mount Sinai School of Medicine	New York	New York
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Clinical Neuroscience Solutions, Inc	Orlando	Florida
United States	Vince and Associates Clinical Research	Overland Park	Kansas
United States	Pedia Research	Owensboro	Kentucky
United States	Four Rivers Clinical Research	Paducah	Kentucky
United States	CRI Worldwide, LLC	Philadelphia	Pennsylvania
United States	HOPE Research Institute	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Oregon Center for Clinical Investigations, Inc	Portland	Oregon
United States	University of Rochester, School of Medicine and Dentistry	Rochester	New York
United States	Peninsula Research Associates Inc	Rolling Hills Estates	California
United States	Oregon Center for Clinical Investigations, Inc	Salem	Oregon
United States	SUNY Upsate Medical University	Syracuse	New York
United States	Childrens Developmental Center	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

References & Publications (1)

Connor DF, Findling RL, Kollins SH, Sallee F, López FA, Lyne A, Tremblay G. Effects of guanfacine extended release on oppositional symptoms in children aged 6-12 years with attention-deficit hyperactivity disorder and oppositional symptoms: a randomized, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Oppositional Subscale of the Conners' Parent Rating Scale-Revised Long Form (CPRS-R:L) Score at Up to 8 Weeks	The oppositional subscale of the CPRS-R:L contains 10 items designed to reflect criteria for oppositional defiance disorder (ODD). Each item is scored on a range from 0 (not true at all) to 3 (very much true) with total scores ranging from 0 to 30. Higher scores are reflective of more severe symptoms.	Baseline and up to 8 weeks
Secondary	Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) Total Score at Up to 8 Weeks	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 up to 8 weeks
Secondary	Assessment of Clinical Global Impression-Severity of Illness (CGI-S)	CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)	up to 8 weeks
Secondary	Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I)	CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.	up to 8 weeks
Secondary	Change From Baseline in the 40-Item Conduct Problem Scale of the New York Parent's Rating Scale-School-aged (NYPRS-S) Score at Up to 8 Weeks	Each item on the NYPRS-S is scored from a range of 0 (not at all) to 3 (very much) with total scores ranging from 0 to 120. Higher scores are reflective of increased disease severity.	Baseline and up to 8 weeks
Secondary	Change From Baseline in the Parent Stress Index-Short Form (PSI/SF) Score at Up to 8 Weeks	The response to each of the 36 items on the PSI/SF is converted to a five-point scale from 1 (strongly agree) to 5 (strongly disagree) with total scores ranging from 36 to 180. A higher score is reflective of less stress for the parents.	Baseline and up to 8 weeks
Secondary	Number of Participants With Overall Satisfaction on the Medication Satisfaction Survey (MSS)	The Medication Satisfaction Survey (MSS) consists of 11 questions each being answered with one of six responses (strongly agree, agree, somewhat agree, somewhat disagree, disagree, strongly disagree). Overall satisfaction with their child taking the study medication, Question #11, with a response of "strongly agree" or "agree".	up to 8 weeks
Secondary	Change From Baseline in Electrocardiogram Results (QTcF Interval) at Up to 8 Weeks	QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate (e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.	Baseline and up to 8 weeks
Secondary	Change From Baseline in Pulse Rate at Up to 8 Weeks		Baseline and up to 8 weeks
Secondary	Change From Baseline in Systolic Blood Pressure at Up to 8 Weeks		Baseline and up to 8 weeks
Secondary	Change From Baseline in Diastolic Blood Pressure at Up to 8 Weeks		Baseline and up to 8 weeks

External Links

•   FDA recall information
•   FDA-approved label