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

September 6, 2018 updated by: Maastricht University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands
        • Maastricht University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo oral capsule
Experimental: Extended-release Guanfacine Hydrochloride (SPD503)
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.
Other Names:
  • Extended-release Guanfacine Hydrochloride
  • SPD503

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Shire

Investigators

  • Principal Investigator: Andries Korebrits, prof. Dr., Psychiatrie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2011

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 9, 2011

First Submitted That Met QC Criteria

September 6, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Actual)

September 7, 2018

Last Update Submitted That Met QC Criteria

September 6, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101081

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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