Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD and Previously Participated in MTS Trials
Phase 3
Completed
- Conditions
- Attention Deficit Disorder With Hyperactivity
- Interventions
- Registration Number
- NCT00151957
- Lead Sponsor
- Noven Therapeutics
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Methylphenidate transdermal system Methylphenidate Transdermal System MTS Patch 27.5mg, 41.3mg, 55mg, and 82.5mg for 7 Weeks
- Primary Outcome Measures
Name Time Method Treatment emergent adverse events over 12 months. Weekly
- Secondary Outcome Measures
Name Time Method ADHD-RS-IV scores Weekly Parent Global Assessment Weekly Clinical Global Impressions Scale Weekly Child's Sleep Habits Questionnaire Weekly