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SPD465

Phase 2

Attention-Deficit/Hyperactivity Disorder | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Jun 3, 2021

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 Enrollment86
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00928148The Safety and Efficacy of SPD465 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)PHASE2 COMPLETED 86 — — Jun 14, 2004Nov 20, 2004Jun 3, 2021 - —
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Study Endpoints
Primary Endpoints
To assess the duration of efficacy of SPD465 compared to placebo and immediate release amphetamine formulation in adults with ADHD using the Permanent Product Measure of Performance (PERMP) math test
-0.5, 2, 4, 8, 12, 14 and 18 hours post-dose
Secondary Endpoints
To assess the duration of efficacy of SPD465 compared with placebo and immediate release amphetamine on ADHD symptoms as determined by the ADHD-rating scale (ADHD-RS)
5, 10 and 15 hours post-dose
To assess the duration of efficacy of SPD465 compared with placebo and immediate release amphetamine on ADHD symptoms as determined by the Swanson, Kotkin, Agler, M. Flynn, and Pelham (SKAMP) scale
5, 10, and 15 hours post-dose
To assess the impact of SPD465 compared with placebo and immediate release amphetamine on sleep as measured by the modified Pittsburgh Sleep Quality Index (PSQI)
21 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SPD465 (50 or 75 mg)EXPERIMENTAL -
Immediate Release Amphetamine salt (25 mg)ACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
SPD465DRUG50 or 75 mg once daily for 7 days
Immediate Release Amphetamine SaltDRUG25 mg once daily for 7 days
PlaceboDRUGOnce daily for 7 days
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Adult men and non-pregnant women between the ages of 18 and 55 * Confirmed diagnosis of ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) * Baseline ADHD score of at least 24 Exclusion Criteria: * Weight l...

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