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OROS*-Methylphenidate

Phase 3

Attention Deficit Hyperactivity Disorder | Small molecule | Other |Johnson & Johnson|Last Updated: May 17, 2011

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment147
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00304681An Effectiveness and Safety Study of CONCERTA* vs. Immediate Release Methylphenidate (IR MPH) in Attention Deficit Hyperactivity Disorder ChildrenPHASE3 COMPLETED 147 -Feb 1, 2004May 17, 2011 -
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Study Endpoints
Primary Endpoints
Change in average SNAP-IV(Swanson, Nolan and Pelham -IV) score from baseline at end of study and the remission of symptoms between groups, defined as an average SNAP-IV score of <=1 at end of study
Secondary Endpoints
changes at end of study for Parenting Stress Index, Conners Parent Rating Scale, IOWA Conners Parent Rating Scale, Visual Analogue Scale for homework and social play, Resource Use Questionnaire, parent satisfaction, Clinical Global Impression
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
OROS*-MethylphenidateDRUG -
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Eligibility Criteria
Age Range6 Years — 12 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients must be between 6 and 12 years of age inclusive, have a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) as defined by the DSM-IV established through clinical interview by the investigator and corroborated by the SNAP-IV parent rating scale, who in the opi...

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