Study to Evaluate Safety & Efficacy of d-Amphetamine Transdermal System Compared to Placebo in Children & Adolescents With ADHD

The study will consist of a four-week screening period, a 3-day wash-out period (if
applicable), a five-week open-label, step-wise dose optimization period and two-week double
blind randomized crossover treatment period with weekly classroom assessments and a safety
follow-up by telephone 7 - 10 days after last dose of study drug.

Inclusion Criteria:

- Gender: Male or female;

- Age: Between 6 &17 years of age, inclusive;

- Race: All eligible;

- Females of child-bearing potential must agree to practice a clinically accepted
method of contraception during the study & for at least one month prior to study
dosing & one month following completion of the study. Acceptable contraceptive
methods include abstinence, oral contraception, surgical sterilization (bilateral
tubal ligation, bilateral oophorectomy or hysterectomy), intrauterine device, or
diaphragm in addition to spermicidal foam & condom on male partner, or systemic
contraception [e.g. Norplant System];

- Must meet Diagnostic & Statistical Manual of Mental Disorders, 4th edition - Text
Revision criteria for a primary diagnosis of ADHD combined, predominately hyperactive
impulsive type, or predominately inattentive type;

- The screening & baseline visit ADHD-RS-IV total score must be 90% or greater relative
to the general population of children by age & gender;

- Must be able to wear a patch for 9 hours. Parent or caregiver must be present to
apply & remove the patches & maintain the used & unused patches in a secure
controlled area of the home;

- Must be functioning at an age appropriate level intellectually as determined by an
intelligence quotient of ≥80 on the Wechsler Abbreviated Scale of Intelligence II™,
vocabulary & matrix reasoning components;

- Must have the ability to complete PERMP assessment;

- Have parental consent & written or verbal assent from the subject;

- Subject & parent(s)/caregiver are willing & able to comply with all the protocol
requirements & parent(s) or caregiver must be able to provide transportation for the
subject to & from the analog classroom sessions.

Exclusion Criteria:

- Has blood pressure & pulse outside the 95th percentile for age & gender;

- Is a known non-responder to amphetamine treatment;

- Has a documented allergy, intolerance, or hypersensitivity to amphetamine;

- Is currently taking an ADHD medication that is providing symptom control with no
residual impairment at home or school & has acceptable tolerability & adherence;

- Has a recent history (within the past 6 months) of suspected substance abuse or
dependence disorder (including nicotine);

- Has a history of seizures during the last 2 years (exclusive of 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 are not
exclusionary;

- Has any psychiatric disorder that could interfere with study participation or the
safety of the subject or other participants, such as conduct disorder or oppositional
defiant disorder 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;

- Has Autism or Asperger's Disorder;

- Has a family history (first degree relatives) of sudden cardiac death;

- Has 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,
considered a suicide risk, has previously attempted suicide, has prior history of or
is currently demonstrating suicidal ideation;

- Has a history of abnormal thyroid function;

- Has BMI for age greater than 95th percentile per CDC BMI-for-gender specific charts;

- Has a known history of symptomatic cardiovascular disease, advance 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;

- Has any skin abnormality present at the potential application site that is likely to
be aggravated by the study drug (i.e., infection, rash, atrophy, excessive fragility
or dryness, any cut or abrasion, or tattoo);

- Has a history of hypersensitivity, allergy to topical medication, preparation, or
adhesive dressings;

- Has 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;

- Has used any investigational drug within 30 days of the screening visit;

- Has a history of physical, sexual, or emotional abuse in the last year;

- Has a medical history of Hepatitis A, B,C or HIV;

- Has positive urine drug screen.