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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03662763
Other study ID # 101081
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2011
Est. completion date December 2013

Study information

Verified date September 2018
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date December 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender All
Age group 6 Years to 17 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
Placebo oral capsule


Locations

Country Name City State
Netherlands Maastricht University Medical Centre Maastricht

Sponsors (2)

Lead Sponsor Collaborator
Maastricht University Medical Center Shire

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Attention Deficit Hyperactivity Disorder-Rating Scale -IV 13 weeks
Secondary Clinical Global Impressions-Severity score 13 weeks
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