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

Maastricht University Medical Center12 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Attention Deficit Disorder

Interventions

Extended-release Guanfacine Hydrochloride (SPD503)DRUG

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 capsuleDRUG

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (1)

Maastricht University Medical Centre

Maastricht, Netherlands

Outcomes

Primary Outcomes

Attention Deficit Hyperactivity Disorder-Rating Scale -IV

Time frame: 13 weeks

Secondary Outcomes

Clinical Global Impressions-Severity score

Time frame: 13 weeks

Data from ClinicalTrials.gov

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