Attention Deficit Disorder With Hyperactivity
Conditions
Brief summary
This study will evaluate the long-term safety of MTS in the symptomatic treatment of children aged 6-12 diagnosed with ADHD
Detailed description
Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will evaluate the long-term safety of SPD485 in the symptomatic treatment of children aged 6-12 diagnosed with ADHD
Interventions
MTS Patch 27.5mg, 41.3mg, 55mg, and 82.5mg for 7 Weeks
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 participated in and completed SPD485-201 or participated in and completed a minimum of five of the seven weeks of double-blind treatment in study SPD485-302. Subjects who are participating in N17-021 may enroll in this study following completion of the End of Study/Termination visit procedures. * Females of childbearing potential must have a negative urine pregnancy test at Baseline and must abstain from sexual activity that could result in pregnancy, or use acceptable contraceptives.
Exclusion criteria
* Subject was terminated from SPD485-102, SPD495-201, SPD485-302 OR N17-021 for non-compliance or experienced a serious adverse event resulting in termination from the antecedent protocols * Female subject is pregnant or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment emergent adverse events over 12 months. | Weekly |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Global Impressions Scale | Weekly |
| Child's Sleep Habits Questionnaire | Weekly |
| ADHD-RS-IV scores | Weekly |
| Parent Global Assessment | Weekly |
Outcome results
None listed