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

NCT ID: NCT03662763

Last Updated: 2018-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-12-31

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.

Conditions

Attention Deficit Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

Extended-release Guanfacine Hydrochloride (SPD503)

Group Type: EXPERIMENTAL

Extended-release Guanfacine Hydrochloride (SPD503)

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Placebo oral capsule

Intervention Type: DRUG

Other Intervention Names

Extended-release Guanfacine Hydrochloride; SPD503

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andries Korebrits, prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

psychiatrie

Locations

Maastricht University Medical Centre

Maastricht, , Netherlands

Countries

Netherlands

Other Identifiers

101081

Identifier Type: -

Identifier Source: org_study_id