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TAK-128

Phase 2

Diabetic Neuropathies | Small molecule | Neurology |Takeda Pharmaceutical Company Limited|Last Updated: Feb 28, 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 Enrollment343
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00229437Efficacy and Safety Study of TAK-128 in Treating Subjects With Diabetic Peripheral NeuropathyPHASE2 COMPLETED 343Mar 1, 2005May 1, 2006Feb 28, 201248 United States, Canada
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Study Endpoints
Primary Endpoints
Change from Baseline in composite measure of maximal nerve conduction velocity (Nerve Conduction Studies).
Week 24 or Final Visit
Secondary Endpoints
Change from Baseline in the electrophysiologic parameters for individual nerves, including amplitudes (Nerve Conduction Studies).
Week 24 or Final Visit
Change from Baseline in vibration perception threshold measurements (Quantitative Sensory Testing).
Weeks 12, 24 or Final Visit
Change from Baseline in pain scores (Short-Form McGill Pain Questionnaire).
Weeks: 8, 12, 16, 20, 24 or Final Visit
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TAK-128 5 mg QDEXPERIMENTAL -
TAK-128 50 mg QDEXPERIMENTAL -
TAK-128 100 mg QDEXPERIMENTAL -
Placebo QDPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
TAK-128DRUGTAK-128 5 mg, tablets, orally, once daily for up to 6 months.
PlaceboDRUGTAK-128 placebo-matching tablets, orally, once daily for up to 6 months.
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites48

Inclusion Criteria: * Female subjects of childbearing potential must be nonpregnant, nonlactating and on an acceptable form of contraception. * The subject has fasting clinical laboratory evaluations within the normal reference range for the testing laboratory, or if not, the results must be deemed...

Countries:United StatesCanada
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