Status:
COMPLETED
Classroom Study to Assess Efficacy and Safety of MTS in Pediatric Patients Aged 6-12 With ADHD
Lead Sponsor:
Noven Therapeutics
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
6-12 years
Phase:
PHASE2
Brief Summary
Evaluate the behavioral effects of MTS in children aged 6-12 with ADHD
Detailed Description
Evaluate the behavioral effects measured by the SKAMP deportment scale of MTS compared to placebo in children aged 6-12 with ADHD
Eligibility Criteria
Inclusion
- Primary diagnosis ADHD
- Total score of greater than or equal to 26 on ADHD-RS-IV
- IQ of greater than or equal to 80
- Blood pressure measurements within 95th percentile for age, gender, height at screening and baseline
Exclusion
- Current controlled (requiring a restricted medication) or uncontrolled, comorbid psychiatric diagnosis (except ODD)
- Known nonresponder to psychostimulant treatment
- BMI for age greater than 90th percentile
- History of seizures during last 2 years
- Conduct Disorder
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT00466791
Start Date
August 1 2004
End Date
May 1 2005
Last Update
June 25 2015
Active Locations (1)
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1
UCI Child Development Center
Irvine, California, United States, 92612