Extended-release Guanfacine Hydrochloride in Children/Adolescents With Attention-deficit/Hyperactivity

Attention Deficit Disorder Clinical Trial

— SPD503-315  

Official title:

Phase 3,Double Blind,Placebo-controlled,Multicentre,Randomised-withdrawal,Long-term Maintenance of Efficacy&Safety Study of Extended-release Guanfacine Hydrochloride in Children/Adolescents Aged 6-17 With ADHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03662763
• Other study ID #: 101081
• Status: Completed
• Phase: Phase 3
• Start date: September 2011
• Est. completion date: December 2013

Study information

• Verified date: September 2018
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study to evaluate the long term maintenance of efficacy of using Guanfacine Hydrochloride (SPD-503) for the treatment of ADHD in Children aged 6-17 years in Europe, Australia, Canada and the US.

Description:

The SPD503-315 clinical program has studied the efficacy, safety, and tolerability of this product in treating symptoms of ADHD in children and adolescents aged 6-17 through short-term, placebo-controlled studies and long-termn, open-label studies. This study will more rigorously assess the long-term maintenance of efficacy using a placebo-controlled, randomised-withdrawal design. To date, all of the completed studies conducted as part of the SPD503 proigram have enrolled subjects from the US. This study is designed to evaluate the long-term maintenance of efficacy of SPD503 for the treatment of ADHD in children aged 6-17 years in Europe, Australia, Canada and US.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

• male or female, aged 6-17 years at the time of consent/assent at Screening/Visit 1

• subject meets DSM-IV-TR criteria for primaru diagnosis of ADHD

• subject has a minimum ADHD-RS-IV total score of 32 at enrolment/visit 2

• subject has a minimum CGI-S score of 4 at Enrolment/Visit 2

• subject is able to swallow intact tablets

Exclusion Criteria:

• subject has a current controlled or uncontrolled, co-morbid psychiatric diagnosis.

• subject has a know history or presence of structural cardiac abnormalities

• subject with orthostatic hyupotension or a known history of controlled or uncontrolled hypertension

• current use of any prohibited medication or other medications, including herbal supplements that affet blood pressure, or heart rate or that have CNS effects or affect cognitive performance

• subject is significant overweight based on Centre for disease control and prevention BMI for age gender specific charts. Significantly overweight is defined as a BMI >95 th percentile Children aged 6-12 years with a body weight ,25,0kg, or adolescents aged 13-17 years with a body weight <43 kg or >91 kg at screening/visit 1

• subject is currently considered a suicide risk in the opinion of the investigator

• history of failure to respond to an adequate trial of an alfa2-agonist for the treatment of ADHD.

Related Conditions & MeSH terms

• Attention Deficit Disorder
• Attention Deficit Disorder with Hyperactivity

Intervention

Drug:
• Extended-release Guanfacine Hydrochloride (SPD503)
dosing in all subjects will initiate with 1mg/day, and may be increased by 1 mg increments after a minimum of 1 week on the current dose to the maximum doses based on age and weight.
• Placebo oral capsule

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Shire

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attention Deficit Hyperactivity Disorder-Rating Scale -IV		13 weeks
Secondary	Clinical Global Impressions-Severity score		13 weeks