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TAK-128

Phase 2

Diabetic Neuropathies | Small molecule | Neurology |Takeda Pharmaceutical Company Limited|Last Updated: Feb 28, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment343

FDA Designations

No designations recorded

Clinical trial landscape

TAK-128 · 1 trial · 1 indication

Phase 2 1
NCT00229437Efficacy and Safety Study of TAK-128 in Treating Subjects With Diabetic Peripheral NeuropathyDiabetic Neuropathies
COMPLETED343 Analytics
PHASE2COMPLETED
Efficacy and Safety Study of TAK-128 in Treating Subjects With Diabetic Peripheral Neuropathy
Diabetic NeuropathiesUnlock trial analytics

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 to 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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Frequently asked questions about TAK-128

What is TAK-128 used for?

TAK-128 is an investigational small molecule being studied for the treatment of diabetic neuropathies, specifically diabetic peripheral neuropathy. It is a Phase 2 drug candidate developed by Takeda Pharmaceutical Company Limited. The drug is not approved and remains in clinical development.

What does TAK-128 target?

The molecular target of TAK-128 has not been disclosed in available information. It is a small molecule being investigated for diabetic peripheral neuropathy, but its specific mechanism of action is not publicly detailed.

Who makes TAK-128?

TAK-128 is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol TAK. The drug is currently in Phase 2 clinical development for diabetic neuropathies.

What phase is TAK-128 in?

TAK-128 is in Phase 2 clinical development. It has completed one Phase 2 trial, and it is not FDA approved. The drug remains investigational and has not yet advanced to Phase 3 or received regulatory approval.

What clinical trials is TAK-128 in?

TAK-128 has one completed clinical trial, NCT00229437, titled 'Efficacy and Safety Study of TAK-128 in Treating Subjects With Diabetic Peripheral Neuropathy.' This Phase 2, randomized, double-blind, placebo-controlled study enrolled 343 participants in the United States and Canada.

Is TAK-128 the same as any other drug?

No alternative names for TAK-128 have been disclosed. The drug is known only by its development code TAK-128, and no other brand or chemical names have been publicly associated with it.