Efficacy & Safety of KAPVAY™ Extended-Release in Children & Adolescents With Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: clonidine hydrochloride; Placebo
Intervention description: KAPVAY™ (clonidine hydrochloride) 0.1 mg, 0.2 mg, 0.3 mg, or 0.4 mg from Weeks 11-36; KAPVAY™ (clonidine hydrochloride) 0.1 mg, 0.2 mg, or 0.3 mg at Week 11; KAPVAY™ 0.1 mg, KAPVAY™ 0.2 mg, or placebo at Week 12; KAPVAY™ 0.1 mg or placebo at Week 13; placebo from Weeks 14-36
Intervention MeSH terms: Clonidine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 135.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Attention Deficit Hyperactivity Disorder

Summary:

      The purpose of this study is to determine the long-term efficacy and safety of KAPVAY™
      (clonidine hydrochloride) extended-release in children and adolescents with Attention Deficit
      Hyperactivity Disorder (ADHD)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, aged 6 to 17 years inclusive

          -  Subject as well as parent/guardian is able to sign the informed assent or consent form

          -  Subject meets Diagnostic and Statistical Manual of Mental Disorders 4th edition, Text
             Revision (DSM-IV-TR) criteria for a primary diagnosis of Attention Deficit
             Hyperactivity Disorder (ADHD), combined subtype, hyperactive/impulsive subtype, or
             inattentive sub-type based on a detailed psychiatric evaluation using the Shorter
             version of the Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and
             Lifetime (MINI-Kid) or DSM-IV TR based checklist for ADHD

          -  Subject has a minimum of Attention Deficit Hyperactivity Disorder-Rating Scale-4th
             edition (clinician version) total score of 28 at baseline (Visit 2)

          -  Subject has a minimum of Clinical Global Impressions-Severity of Illness Scale of 4 at
             baseline (Visit 2)

          -  Subject is able to swallow intact tablets based upon interview and screening
             procedures

          -  Subject is functioning at an age-appropriate level intellectually with an estimated
             intelligence quotient of at least 70 based on interview and history

          -  Subject and parent/guardian understand, are willing, to fully comply with the study
             requirements, procedures, and restrictions defined in this protocol

          -  Subject has a supine and standing blood pressure measurement within the 95th
             percentile for age, gender, and height

          -  If a female has experienced menarche, she must have a negative serum beta human
             chorionic gonadotropin pregnancy test at screening (Visit 1), negative urine pregnancy
             test at baseline (Visit 2), agree to be abstinent from sexual activity that could
             result in pregnancy, or use acceptable contraceptives throughout the period of the
             study drug exposure and for 30 days after the last dose of the study drug

        Exclusion Criteria:

          -  Subject has a current comorbid psychiatric condition (except oppositional defiant
             disorder) that is controlled (requiring a prohibited medication or behavioral
             modification program) or uncontrolled.

          -  Subject has any condition or illness including clinically significant abnormal
             screening (Visit 1) laboratory values that, in the opinion of the investigator,
             represents an inappropriate risk to the subject and/or could confound the
             interpretation of the study

          -  Subject has a known history or presence of structural cardiac abnormalities, serious
             heart rhythm abnormalities, syncope, cardiac conduction problems (eg, clinically
             significant heart block), exercise-related cardiac events including syncope and
             presyncope, or clinically significant bradycardia

          -  Subject is pregnant or nursing (lactating) or deemed by the investigator and staff to
             be at a significant risk of becoming pregnant.

          -  Subject has orthostatic hypotension or a known history of controlled or uncontrolled
             hypertension

          -  Subject has clinically significant electrocardiogram (ECG) findings as judged by the
             investigator with consideration of the central ECG laboratory's interpretation.

          -  Current use of any prohibited medication or other medications including herbal
             supplements that affect blood pressure, or heart rate, or that have central nervous
             system 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 (ie, antihistamines) in violation of the protocol
             specified washout criteria at baseline (Visit 2)

          -  Subject has used an investigational product within 30 days prior to baseline (Visit 2)

          -  Subject is significantly overweight based on body mass Index (BMI) for age-and
             gender-specific charts compiled by Center for Disease Control and Prevention.
             Significantly overweight is defined as a BMI of ≥95th percentile

          -  Subject is significantly underweight based on BMI for age-and gender-specific charts
             compiled by Center for Disease Control and Prevention.

          -  Subject has a known or suspected allergy, hypersensitivity, or clinically significant
             intolerance to clonidine hydrochloride

          -  Clinically important abnormality on drug and alcohol screening (excluding the
             subject's current ADHD stimulant if applicable) at screening (Visit 1)

          -  Subject has a history of alcohol, other substance abuse, or dependence as defined by
             DSM-IV-TR (with the exception of nicotine) within the last 6 months.

          -  Subject is currently considered a suicidal risk in the opinion of the investigator,
             has previously made a suicide attempt, has a prior history of, or is currently
             demonstrating active suicidal ideation based on the Columbia Suicide Severity Rating
             Scale (C-SSRS).

          -  Subject has a history of failure to respond to an adequate trial of an alpha 2-agonist
             with stimulant or non-stimulant drug alone or in combination for the treatment of
             ADHD.

          -  Subject has a history of a seizure disorder (other than a single childhood febrile
             seizure occurring before the age of 3 years) or the presence of a serious tic disorder
             (including Tourette syndrome)

          -  Subjects who have been treated with an immediate release clonidine and/ KAPVAY™ or
             guanfacine (INTUNIV™) within the past 30 days