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TAK-583

Phase 2

Neuralgia, Postherpetic | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Feb 2, 2012

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment399
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00377598Efficacy, Safety and Tolerability Study of TAK-583 in Subjects With Postherpetic NeuralgiaPHASE2 COMPLETED 399 — — Oct 1, 2006Feb 1, 2008Feb 2, 201248 Australia, Bulgaria +7
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Study Endpoints
Primary Endpoints
Change from Baseline in average daily pain intensity score for the previous 7 days
Week 8 or Final Visit
Secondary Endpoints
Change from baseline to each study visit in average daily pain intensity score for the last 7 days
At All Visits
Change from baseline in pain assessment as assessed by Short form McGill Pain Questionnaire
Week 8 or Final Visit
Change from baseline in weekly mean sleep interference scores (assessed on an 11-point numerical scale in the subject's sleep diary)
Week 8 or Final Visit
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TAK-583 5 mg QDEXPERIMENTAL -
TAK-583 25 mg QDEXPERIMENTAL -
TAK-583 50 mg QDEXPERIMENTAL -
TAK-583 100 mg QDEXPERIMENTAL -
Placebo QDPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
TAK-583DRUGTAK-583 5 mg, tablets, orally, once daily for up to 8 weeks
PlaceboDRUGTAK-583 placebo-matching tablets, orally, once daily for up to 8 weeks
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Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites48

Inclusion Criteria: * Male and female subjects with postherpetic neuralgia whose pain has been present for \>3 months following healing of the herpes zoster rash. * Subjects with an mean pain intensity score of 4 or more (determined from at least 4 daily recordings of pain intensity on an 11-point ...

Countries:AustraliaBulgariaCzechiaGermanyNetherlandsPolandRussiaSouth AfricaUnited Kingdom
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