Attention Deficit Disorder With Hyperactivity
Conditions
Brief summary
This study will assess the safety and tolerability of MTS while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.
Detailed description
Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will assess the safety and tolerability of SPD485 while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.
Interventions
To assess the efficacy of 4- and 6-hour wear times of SPD485 (MTS) compared to placebo
Sponsors
Noven Pharmaceuticals, Inc.
Noven Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Subject must have a primary diagnosis of ADHD * Subject must be adequately controlled on a stable dose of one of the following medications for a 30 day period: Ritalin LA(r), Concerta(r), or Metadate DC(r), not to exceed 54 mg per day * Females of childbearing potential must have a negative serum beta Human Chorionic Gonadotropin pregnancy test
Exclusion criteria
* A history of mental retardation that would indicate that the subject is not functioning at an age appropriate level intellectually * A recent history of suspected substance abuse or dependence disorder * Subject is taking Strattera * Clinical signs and symptoms of skin irritation or hyper/hypopigmentation at the potential application sites
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Score on ADHD Rating Scale at 4 weeks | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Parent Global Assessment | 30 days |
| Medication Satisfaction Survey | 30 days |
| Parent rating scale | 30 days |
| Clinical Global Impressions Scale | 30 days |
| Adverse events, lab tests, dermal evaluations, ECGs | 30 days |
| ADHD Impact Module | 30 days |
Countries
United States
Outcome results
None listed