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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662763
Recruitment Status : Completed
First Posted : September 7, 2018
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Maastricht University Medical Center

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder Drug: Extended-release Guanfacine Hydrochloride (SPD503) Drug: Placebo oral capsule Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : December 2013


Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo oral capsule
Experimental: Extended-release Guanfacine Hydrochloride (SPD503) 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.
Other Names:
  • Extended-release Guanfacine Hydrochloride
  • SPD503




Primary Outcome Measures :
  1. Attention Deficit Hyperactivity Disorder-Rating Scale -IV [ Time Frame: 13 weeks ]

Secondary Outcome Measures :
  1. Clinical Global Impressions-Severity score [ Time Frame: 13 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662763


Locations
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Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Shire
Investigators
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Principal Investigator: Andries Korebrits, prof. Dr. psychiatrie
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03662763    
Other Study ID Numbers: 101081
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Guanfacine
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs