Extended-release Guanfacine Hydrochloride in Children/Ado... | NCT03662763

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

NCT03662763

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Sep 7, 2018Actual

Enrollment

12Actual

Phase

Phase 3

Conditions

Attention Deficit Disorder

Interventions

Extended-release Guanfacine Hydrochloride (SPD503)
Placebo oral capsule

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011Actual

Primary Completion Date

Aug 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Aug 9, 2011

First Submission Date that Met QC Criteria

Sep 6, 2018

First Posted Date

Sep 7, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2018

Last Update Posted Date

Sep 7, 2018Actual

Name	Class
Shire	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Drug: Placebo oral capsule
Extended-release Guanfacine Hydrochloride (SPD503)	Experimental		Drug: Extended-release Guanfacine Hydrochloride (SPD503)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

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

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

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Andries Korebrits, prof. Dr.	psychiatrie	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

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