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Methylphenidate

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 Trials1
Total Enrollment130
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00254878Placebo-Controlled Comparison of Two Different Brands of Modified-Release Oral Dosage Forms Regarding Safety and Efficacy in Children With Attention Deficit Hyperactivity Disorder (ADHD) Aged 6 - 14PHASE3 COMPLETED 130Oct 1, 2005Feb 1, 2006Dec 21, 20071 Germany
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Study Endpoints
Primary Endpoints
Attention and deportment measured at 1.5, 3.0 and 4.5 hours after drug intake
Secondary Endpoints
7 week's treatment with two different brands of modified-release oral dosage forms of methylphenidate-HCl on attention, deportment, behavior and math in children with attention deficit hyperactivity disorder (ADHD) aged 6 - 14
Safety of 7 week's treatment with two different brands of modified-release oral dosage forms of methylphenidate-HCl
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Interventions
NameTypeDescription
Methylphenidate hydrochlorideDRUG -
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Eligibility Criteria
Age Range6 Years — 14 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Patients who meet all of the following inclusion criteria will be eligible for enrollment in the study: * Male and female patients aged 6-14. * Patients having a diagnosis of ADHD of any type according to DSM-IV criteria, as established by history, psychiatric examination and a...

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