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NWP09

Phase 3

Attention Deficit Hyperactivity Disorder | Small molecule | Other |Pfizer, Inc.|Last Updated: Feb 3, 2016

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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment90
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01654250NWP09 in Children With Attention Deficit Hyperactivity Disorder (ADHD)PHASE3 COMPLETED 90Jul 1, 2012Oct 1, 2012Feb 3, 20169 United States
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Study Endpoints
Primary Endpoints
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores-Average of All Post-Dose Time-Points
0.75 up to 13 hours post-dose

The SKAMP scale measured the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP composite score was obtained by summing up each item score where each item was rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment. Average of all post dose SKAMP-combined scores measured at 0.75, 2, 4, 8, 10, 12 and 13 hours post-dose was calculated.

Secondary Endpoints
Onset and Duration of Clinical Effect
0.75, 2, 4, 8, 10, 12, 13 hours post-dose
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP) SKAMP Attention and Deportment Subscale Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose
0.75, 2, 4, 8, 10, 12, 13 hours post-dose
Permanent Product Measure of Performance (PERMP) Scores at Hour 0.75, 2, 4, 8, 10, 12 and 13 Post-Dose
0.75, 2, 4, 8, 10, 12 and 13 post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ActiveEXPERIMENTALNWP09
PlaceboPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
NWP09DRUGMethylphenidate, variable dose, daily dosing, 1 week duration
PlaceboDRUGPlacebo
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Eligibility Criteria
Age Range6 Years — 12 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Children aged 6 to 12 years with ADHD who require pharmacologic treatment for this condition Exclusion Criteria: * Other serious illnesses or conditions that would put the patient at particular risk for safety events or would interfere with treatment/assessment of ADHD

Countries:United States
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