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Focalin

Phase 3

ADHD | Small molecule | Psychiatry |Novartis AG|Last Updated: Dec 21, 2007

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment180
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00141063Safety and Efficacy Study of Dexmethylphenidate in Children With ADHDPHASE3 COMPLETED 90 — — Jun 1, 2005Aug 1, 2005Dec 21, 20071 United States
NCT00141050Safety and Efficacy Study of Dexmethylphenidate in Children With ADHDPHASE3 COMPLETED 90 — — May 1, 2005Jul 1, 2005Dec 21, 20071 United States
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Study Endpoints
Primary Endpoints
Change in attention and deportment measured at 2 hours post-dose
Secondary Endpoints
Onset of effect at 0.5, 1, 2, 3, 4, 6, 8, 10, 11, and 12 hours post-dose
Parent's assessment of patient behavior across all treatment periods as measured by the change from baseline
Safety and tolerability of two doses of dexmethylphenidate compared to two doses of an approved, long-acting, marketed medication for ADHD and placebo in children ages 6-12 diagnosed with ADHD.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
Focalin XRDRUG -
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Eligibility Criteria
Age Range6 Years — 12 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * DSM-IV diagnosis of ADHD * Males and females aged 6-12 Exclusion Criteria: * Inability of understand or follow instructions * Is pregnant * Diagnosis of tic disorder * History of seizure disorder

Countries:United States
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Competitive Landscape -ADHD 3 trials
CompanyTickerTrialsLead PhaseDrugs
Supernus Pharmaceuticals, Inc.SUPN1PHASE3SPN-812
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