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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Attention Deficit Disorder

Intervention / Treatment
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* Drug: Extended-release Guanfacine Hydrochloride (SPD503)
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo oral capsule<br> <br> |
| Experimental: Extended-release Guanfacine Hydrochloride (SPD503)<br> | Drug: Extended-release Guanfacine Hydrochloride (SPD503)<br>* 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.<br>* Other names: SPD503;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attention Deficit Hyperactivity Disorder-Rating Scale -IV |  | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impressions-Severity score |  | 13 weeks |