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

NCT03662763 | Completed Phase 3 DMC

• 1 other identifier: 101081
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Disorder

Outcome Measures

Primary Outcomes (1)

• Attention Deficit Hyperactivity Disorder-Rating Scale -IV

  13 weeks

Secondary Outcomes (1)

• Clinical Global Impressions-Severity score

  13 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo oral capsule

Extended-release Guanfacine Hydrochloride (SPD503)

EXPERIMENTAL

Drug: Extended-release Guanfacine Hydrochloride (SPD503)

Interventions

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.

Also known as: Extended-release Guanfacine Hydrochloride, SPD503

Extended-release Guanfacine Hydrochloride (SPD503)

Placebo oral capsule DRUG

Placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Shire: collaborator

Study Sites (1)

Maastricht University Medical Centre

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Andries Korebrits, prof. Dr.

  psychiatrie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: September 7, 2018
• Study Start: September 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

NL (1)