Study to assess the long term safety and efficacy of Guanfacine-Hydrochloride in Children and Adolescents aged 6-17 years old, with Attention- Deficit/Hyperactivity Disorder

Phase 1

• Conditions: Attention-Deficit/Hyperactive Disorder (ADHD); MedDRA version: 14.1Level: LLTClassification code 10068451Term: ADHD, combined typeSystem Organ Class: 100000004873; MedDRA version: 14.1Level: LLTClassification code 10068453Term: ADHD, predominantly inattentive typeSystem Organ Class: 100000004873; MedDRA version: 14.1Level: LLTClassification code 10068452Term: ADHD, predominantly hyperactive-impulsive typeSystem Organ Class: 100000004873; MedDRA version: 14.1Level: LLTClassification code 10064104Term: ADHDSystem Organ Class: 100000004873; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2009-018161-12-BE
• Lead Sponsor: Shire Development Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-22
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 510

Inclusion Criteria

1. Male or female, aged 6 to 17 years at the time of consent/assent at Screening/Visit 1.
2. Subject meets Diagnostic and Statistical Manual of Mental Disorders, 4th ed. Text Revision (DSM IV TR) criteria for a primary diagnosis of ADHD, combined sub-type, hyperactive/impulsive sub-type, or inattentive sub-type based on a detailed psychiatric evaluation using the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime version (K-SADS-PL).
3. Subject has a minimum ADHD-RS-IV total score of 32 at Enrolment/Visit 2.
4. Subject has a minimum CGI-S score of 4 at Enrolment/Visit 2. 5. Subject is able to swallow intact tablets.
Are the trial subjects under 18? yes
Number of subjects for this age range: 510
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subject has a current, controlled (requiring a prohibited medication or behavioural modification program) or uncontrolled, co-morbid psychiatric diagnosis, except Oppositional Defiant Disorder (ODD), including any severe comorbid Axis II disorders or severe Axis I disorders such as Post Traumatic Stress Disorder, bipolar illness, psychosis, pervasive developmental disorder, obsessive-compulsive disorder, substance abuse disorder, or other symptomatic manifestations or lifetime history of bipolar illness, psychosis, or conduct disorder that, in the opinion of the Investigator, contraindicate SPD503 treatment or confound efficacy or safety assessments.
2. Subject has a known history or presence of structural cardiac abnormalities, serious heart rhythm abnormalities, syncope, cardiac conduction problems (e.g., clinically significant heart block), exercise related cardiac events including syncope and pre-syncope, or clinically significant bradycardia.
3. Subject with orthostatic hypotension or a known history of controlled or uncontrolled hypertension.
4. Current use of any prohibited medication or other medications, including herbal supplements, that affect blood pressure (BP) or heart rate or that have central nervous system (CNS) effects or affect cognitive performance, such as sedating antihistamines and decongestant sympathomimetics (inhaled bronchodilators are permitted) or a history of chronic use of sedating medications (i.e., antihistamines) in violation of the protocol specified washout criteria at Enrolment/Visit 2.
5. Subject is significantly overweight based on Centre for Disease Control and Prevention Body Mass Index (BMI)-for-age gender specific charts. Significantly overweight is defined as a BMI >95th percentile.
6. Children aged 6-12 years with a body weight of <25.0kg or adolescents aged 13-17 years with a body weight of <34.0kg or >91.0kg at Screening/Visit 1.
7. Subject has a history of alcohol or other substance abuse or dependence, as defined by DSM IV TR (with the exception of nicotine) within the last 6 months.
8. Subject is currently considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator (see protocol for additional guidance).
9. History of failure to respond to an adequate trial of an alpha2-agonist for the treatment of ADHD (consisting of an appropriate dose and adequate duration of therapy in the opinion of the Investigator) 10. Subject is well-controlled on their current ADHD medication with acceptable tolerability and the parent/caregiver does not object to the current ADHD medication.
10. Subject is well-controlled on their current ADHD medication with acceptable tolerability and the parent/caregiver does not object to the current ADHD medication.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified