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Completed

NCT Number: NCT03662763

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

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.

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Key information

Conditions

Attention Deficit Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Maastricht University Medical Centre

Maastricht, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Extended-release Guanfacine Hydrochloride, SPD503

Placebo oral capsule

Drug

Primary outcomes

  1. Attention Deficit Hyperactivity Disorder-Rating Scale -IV

    Time frame: 13 weeks

Secondary outcomes

  1. Clinical Global Impressions-Severity score

    Time frame: 13 weeks

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Shire

Registry information

Official study 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

Acronym: SPD503-315

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 7, 2018
Registry last updated
Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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