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

Primary Purpose

Attention Deficit Disorder

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Extended-release Guanfacine Hydrochloride (SPD503)
Placebo oral capsule
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Maastricht University Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Extended-release Guanfacine Hydrochloride (SPD503)

Arm Description

Outcomes

Primary Outcome Measures

Attention Deficit Hyperactivity Disorder-Rating Scale -IV

Secondary Outcome Measures

Clinical Global Impressions-Severity score

Full Information

First Posted
August 9, 2011
Last Updated
September 6, 2018
Sponsor
Maastricht University Medical Center
Collaborators
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT03662763
Brief Title
Extended-release Guanfacine Hydrochloride in Children/Adolescents With Attention-deficit/Hyperactivity
Acronym
SPD503-315
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 2011 (Actual)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Shire

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Extended-release Guanfacine Hydrochloride (SPD503)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Extended-release Guanfacine Hydrochloride (SPD503)
Other Intervention Name(s)
Extended-release Guanfacine Hydrochloride, SPD503
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Primary Outcome Measure Information:
Title
Attention Deficit Hyperactivity Disorder-Rating Scale -IV
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Clinical Global Impressions-Severity score
Time Frame
13 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andries Korebrits, prof. Dr.
Organizational Affiliation
psychiatrie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Centre
City
Maastricht
Country
Netherlands

12. IPD Sharing Statement

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

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