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TD-9855

Phase 2

Attention-Deficit/Hyperactivity Disorder | Small molecule | Psychiatry |Theravance Biopharma, Inc.|Last Updated: Apr 4, 2022

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment295
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01458340A Study of TD-9855 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)PHASE2 COMPLETED 295Dec 1, 2011Nov 1, 2013Apr 4, 202217 United States
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Study Endpoints
Primary Endpoints
Change From Baseline in AISRS Total Score at Day 42
Baseline and Day 42

The AISRS is a modified version of the ADHD Rating Scale that more accurately reflects the impact and severity of ADHD among adults. It is a clinician-administered scale that measures all 18 symptoms of adult ADHD using a Likert scale from 0 (not present) to 3 (severe). The total score ranges from 0 to 54 with a negative change from baseline indicating an improvement in severity/reduction in symptoms.

Secondary Endpoints
Change From Baseline in BDEFS-SF: Self Report Total Score at Day 42
Baseline and Day 42
Change From Baseline in AISRS Inattentive Subscale at Day 42
Baseline and Day 42
Change From Baseline in AISRS Hyperactive-impulsive Subscale at Day 42
Baseline and Day 42
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TD-9855 Dose 1EXPERIMENTAL -
PlaceboEXPERIMENTAL -
TD-9855 Dose 2EXPERIMENTAL -
Interventions
NameTypeDescription
TD-9855DRUGOnce daily
PlaceboDRUGOnce daily
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Subjects must meet the following ADHD diagnostic and inclusion criteria: * Subjects must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for current ADHD subtypes (ADHD combined type, ADHD predominately inattentive...

Countries:United States
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