Study to Evaluate Safety & Efficacy of d-Amphetamine Transdermal System vs Placebo in Children & Adolescents With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Intervention: d-Amphetamine Transdermal Patch; Placebo patch
Intervention description: The study was conducted in 2 parts: a 5 week, open-label, step-wise Dose Optimization Period and a 2-week, randomized, cross-over Double-Blind Treatment Period.
Patches will be worn for 9 hours every day. After 9 hours the patch will be removed. Every day a new patch will be applied.; The study was conducted in 2 parts: a 5 week, open-label, step-wise Dose Optimization Period and a 2-week, randomized, cross-over Double-Blind Treatment Period.
Patches will be worn for 9 hours every day. After 9 hours the patch will be removed. Every day a new patch will be applied.
Intervention MeSH terms: Amphetamine; Dextroamphetamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 110.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: ADHD

Summary:

      This study will evaluate safety and efficacy of d-Amphetamine Transdermal System for the
      treatment of Attention Deficit Hyperactivity Disorder in children and adolescents.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Gender: Male or female

          2. Age: Between 6 and 17 years of age (inclusive)

          3. Race: All eligible

          4. Females of child-bearing potential must have agreed to practice a clinically accepted
             method of contraception during the study and for at least 1 month prior to study
             dosing and 1 month following completion of the study. Acceptable contraceptive methods
             included abstinence, oral contraception, surgical sterilization (bilateral tubal
             ligation, bilateral oophorectomy, or hysterectomy), intrauterine device, diaphragm in
             addition to spermicidal foam and condom on male partner, or systemic contraception
             (e.g., Norplant System)

          5. Must have met Diagnostic and Statistical Manual of Mental Disorders, 4th edition -
             Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD combined,
             hyperactive/impulsive subtype, or predominately inattentive subtype

          6. The Screening and Baseline visit ADHD-RS-IV total score must have been ≥90% of the
             general population of children by age and gender

          7. Able to wear a patch for 9 hours (for children and, if applicable, for adolescents,
             parent or caregiver must be present to apply and remove the patches and maintain the
             used and unused patches in a secure, controlled area of the home)

          8. Functioning at an age-appropriate level intellectually as determined by an
             intelligence quotient (IQ) of ≥80 on the Wechsler Abbreviated Scale of Intelligence
             II™ (WASI II™) vocabulary and matrix reasoning components

          9. Must have been able to complete PERMP assessment

         10. Must have provided parental consent (signed ICF) and obtained written/verbal assent
             from the subject

         11. Subject and parent(s)/ caregiver must have been willing and able to comply with all
             the protocol requirements and parent(s) or caregiver must be able to provide
             transportation for the subject to and from the analog classroom sessions

        Exclusion Criteria:

          1. Blood pressure outside the 95th percentile for age and gender

          2. Pulse of <50 (age 6 - 17), or >120 (age 6 - 12), or >125 (age 13 - 17)

          3. Known non-responder to amphetamine treatment

          4. Documented allergy, intolerance, or hypersensitivity to amphetamine

          5. Currently taking an ADHD medication that is providing symptom control with no residual
             impairment at home or school and has acceptable tolerability and adherence

          6. Recent history (within the past 6 months) of suspected substance abuse or dependence
             disorder (including nicotine)

          7. History of seizures during the last 2 years (excluding infantile febrile seizures), a
             tic disorder (exclusive of transient tic disorder), a current diagnosis, and/or a
             family history of Tourette's Disorder. Mild medication-induced tics were not
             exclusionary

          8. Any psychiatric disorder that could interfere with study participation or the safety
             of the subject or other participants, such as conduct disorder (CD) or oppositional
             defiant disorder (ODD) with a history of prominent aggressive outbursts. Children
             meeting CD or ODD but without prominent aggression will be allowed to enroll at the
             discretion of the Investigator

          9. Autism or Asperger's Disorder

         10. Family history (first degree relatives) of sudden cardiac death

         11. Current controlled (requiring medication) or uncontrolled comorbid psychiatric
             conditions such as post-traumatic stress disorder, psychosis, bipolar illness, severe
             obsessive compulsive disorder, severe depressive or severe anxiety disorder, was
             considered a suicide risk, had recent (last 6 months) suicidal ideation, or any
             lifetime self-harm event

         12. History of abnormal thyroid function

         13. Has a body mass index (BMI) for age greater than 95th percentile per Centers for
             Disease Control BMI (for gender-specific charts)

         14. Known history of symptomatic cardiovascular disease, advanced arteriosclerosis,
             structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities,
             coronary artery disease, or other serious cardiac problems that may place them at
             increased vulnerability to the sympathomimetic effects of a stimulant drug

         15. Any skin abnormality present at the potential application site (i.e., infection, rash,
             atrophy, excessive fragility or dryness, any cut or abrasion, or tattoo)

         16. History of hypersensitivity, allergy to topical medication, preparation, or adhesive
             dressings

         17. Concurrent chronic or significant acute illnesses (such as severe allergic rhinitis or
             an infectious process requiring antibiotics, unless expected to resolve or has
             resolved by Day 0) disability or any unstable medical condition that in the
             Investigator's opinion would lead to difficulty complying with the protocol
             requirements

         18. Used any investigational drug within 30 days of the Screening visit

         19. History of physical, sexual, or emotional abuse in the last year

         20. Medical history of hepatitis A/B/C or HIV

         21. Positive urine drug screen for drugs of abuse