Extended-release Guanfacine Hydrochloride in Children/Adolescents With Attention-deficit/Hyperactivity (SPD503-315)

Maastricht University Medical Centre (MUMC)

Status and phase

Completed

Phase 3

Conditions

Attention Deficit Disorder

Treatments

Drug: Placebo oral capsule

Drug: Extended-release Guanfacine Hydrochloride (SPD503)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03662763

101081

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

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.